30 jobs found in bothell

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-TC1 Biometrics . Bothell, Washington | Seattle, Washington | South San Francisco, California Description Summary: Independently serve as clinical study statistician on multiple projects with limited supervision. Provide expertise in the design and development of study protocols and case report forms. Develop statistical analysis plans, perform statistical analyses, and interpret results. Develop SAS programs of varying complexity to analyze and report clinical data. Review programming specifications and outputs. Recognize inconsistencies and initiate resolution of data problems. Collaborate in the preparation and review of clinical study reports. Ensure adherence to regulatory and company standards. Responsibilities: Perform duties of a study statistician to support clinical trials. Oversee statistical aspects in the design of clinical trials Provide statistical input to study protocols Perform sample size and power calculations Review CRFs and edit checks Develop SAP and create table, listing, and figure shells Review programming specifications and derived datasets Perform or review statistical analysis as defined in SAP Code complex statistical analyses as needed Interpret results and write sections of documents; present results Support program lead statisticians in preparations for interactions with regulatory agencies Read and understand medical/clinical literature as required by duties Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems Working knowledge of FDA regulations, ICH GCP guidelines, the drug development process Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Qualifications: MS in statistics, biostatistics, or related field with 4-7 years of experience, or PhD with 2-5 years of experience Strong SAS programming skills Working knowledge of clinical trial design Knowledge of FDA regulations, ICH GCP guidelines, the drug development process Excellent verbal and written communication skills Demonstrated initiative and motivation Good organizational skills with the ability to adapt and adjust to changing priorities Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required Able to prioritize work and complete deliverables to timelines with limited supervision Detail and process oriented Preferred: Oncology experience preferred Knowledge of R Simulation experience As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com .#LI-TC1 PI114746291

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-SP1 Facilities & Engineering . Bothell, Washington | Bothell, Washington Description Summary: The Instrumentation Technician supports the Facilities & Engineering team. The Instrumentation Technician is responsible for performing calibrations, repairs, installations, troubleshooting and documentation of instruments used in GMP, GLP, R&D laboratories, utilities systems and GMP manufacturing plant. This position reports to the GMP Equipment Supervisor, Facilities & Engineering. This position is classified as essential personnel and as such, is required to work with minimal amount of absences and during all site closures as required except in the event of a major disaster when access to the facilities is prohibited by governmental emergency personnel. Responsibilities: Perform instrument calibrations for process, utility and analytical equipment and systems Troubleshoot and repair site instrumentation and control system issues Perform advanced maintenance and repair activities on equipment and systems used in Manufacturing, Analytical Laboratory or other areas of the Bothell site Support freezer, refrigerator and incubator maintenance Assist in managing and scheduling the vendors performing Seattle Genetics Equipment Maintenance and Calibrations Assist with the equipment enrollment process in the CMMS & Starlims (equipment labeling, parts, tasks, personnel, procedures, measurement data templates, etc.) Ensure activities are accomplished in a safe manner Ensure work is completed in accordance with procedures Ensure work activities are completed correctly Maximize right the first time execution Work in a highly productive and efficient manner to maximize the quantity of activities completed Ensure work is appropriately communicated to system owners and key stakeholders. Ensure work order documentation is completed accurately and completely Identify waste, work flow interrupters, and other opportunities for improvement, recommend solutions, and assisting with implementation Identify opportunities to learn new skills and actively participate in development that will improve overall team performance Provide support when required - this may be outside of normal working hours including nights, weekends and holidays Participate in an On-call rotation for equipment monitoring & alarms Qualifications: Associate degree and 4+ years of Maintenance or Instrumentation experience OR 2 years in a technical school setting with hands-on experience and 4+ years of Maintenance or Instrumentation experience. Education: Associate degree in Maintenance or Instrumentation and Controls As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . #LI-SP1 PI114680142

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-SP1 Finance & Accounting . Bothell, Washington Description Summary: The Manager, Manufacturing Finance will be a financial controller and cross-functional business partner supporting the Technical Operations/Process Sciences (TOPS) organization. Responsibilities: Support the accounting month-end close process: Prepare month-end journal entries and related reconciliations related to clinical Contract CMO accruals Prepare journal entries and lot cost adjustments related to commercial and clinical inventory Review clinical CMO contracts, Purchase Orders, and invoice payments Review monthly transactions in the Oracle Process Manufacturing (OPM) module Prepare monthly departmental statements, including commentary Partner with operational stakeholders to analyze financial results versus Plan Support the annual LRP and Budgeting process for TOPS Collaborate in the development and maintenance of manufacturing (GMP) policies and procedures, as required Collaborate in the development and maintenance of key financial controls (Sarbanes-Oxley) and other financial policies and procedures Support the external audit function, ensuring the accurate and timely completion of quarterly/annual auditor requests Partner with operational stakeholders (Supply Ops, Manufacturing) to support world-wide growth mandates Perform other job duties as assigned Qualifications: 5+ years of increasing responsibility in accounting - cost accounting is a plus Experience in biotechnology and/or manufacturing (plant controller) is strongly preferred Excellent interpersonal and communication skills (written and verbal) Strong analytical and problem-solving skills Proven experience in a financial business partner role Experience with ERP (Oracle or SAP) and support systems CPA or CMA is a plus Education Bachelor of Science degree in Accounting As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . #LI-SP1 PI114680113

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Sales . Bothell, Washington Description Summary: As part of the sales operations team, the Sales Operations Analyst will play a key role in the commercial success for Seattle Genetics. This position will support all aspects of sales operations for the sales teams, as it relates to Sales Operations and technology that is utilized for field enablement of day to day sales activity to include Veeva CRM. The Sales Operations Analyst will be a key role in supporting the success of field sales organization. This position will support all aspects of business operations for the sales team as it relates to Customer Relationship Management (CRM), Technology Integration, Targeting and Data Stewardship. Responsibilities: Provide ongoing operational support of the sales force automation/customer relationship management system and processes Conceptualize, develop and maintain field and HQ facing CRM and sales reporting dashboards Partner with other commercial team members to understand business needs, propose solutions and lead the development of projects Deliver regular reporting and ad hoc analyses of such topics as product sales and other business performance metrics Provide support for customer targeting, field sizing and structure and territory alignments Contribute complimentary support to sales goal modeling and incentive compensation plan design Ensure ongoing data quality and optimized database structure for use in the customer master Support the acquisition of new data sources and the management of existing data streams into the SeaGen data warehouse Work cross-functionally with numerous internal teams, such as Marketing, Global Market Insights (GMI), Information Technology and Finance Participate in variety of special projects, as needed Requirements: Bachelor's/ Master's Degree preferred with specialization in Computer Science, MIS, IT or other computer related disciplines 3 or more years of relevant experience in data management, business analyses and microstrategy hands-on development Strong understanding of statistics and modeling techniques, as well as knowledge of statistical analysis software High level of proficiency with Excel, PowerPoint and Word Understanding of database technology and experience with query (business intelligence tools) Fundamental understanding of SFDC CRM applications (Veeva preferred) Work closely with the Information Technology group to determine optimum solutions Experience administering IT applications that support Commercial Operations Ability to develop complex reports and model workflow with technology solutions a plus Previous experience in pharmaceutical, biotech or related industry is preferred Must be "hands-on" and ready to roll up their sleeves to deliver immediate results Ability to distill complex concepts into easy-to-understand frameworks and presentations Proven ability to work creatively and analytically in a problem-solving environment Attention to detail; strong prioritization, communication and organization skills; solid team player As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114553290

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Clinical Affairs . Bothell, Washington Description Summary: This position will serve as the Executive Medical Director for ADCETRIS and will be responsible for developing and executing the clinical development strategy ADCETRIS and other CD30 directed therapies, in addition to overseeing the clinical trial program. Reporting to the Vice President, Clinical Development the successful candidate should have demonstrated proficiency in leading and supporting development programs across multiple functions within a company, as well as represent the program with the external clinical community. Responsibilities: Lead, develop and execute the strategic development of clinical program for ADCETRIS and other CD30 directed therapies Work across the organization and on multifunctional teams responsible for the development of ADCETRIS and other CD30 directed therapies. Will be the lead and decision maker for the Global Development Team and serve and lead clinical on the Global Product Team Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports Provide leadership to medical directors and clinical scientists who lead the ADCETRIS clinical study teams Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies in ADCETRIS Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards Conduct literature reviews and prepare summaries to support clinical development programs Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates Requirements: Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders Demonstrates a passion for helping patients with cancer and for the science of oncology Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals Is a team player, works well in a team environment both as a leader and a key contributor Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies Qualifications: MD or MD/PhD Clinical oncology experience; Board certification in oncology or hematology preferred 5-7 years industry experience in oncology drug development preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114553308

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Quality . Bothell, Washington Description Summary: The Manager/Sr. Manager of Document Management provides leadership over the GMP Document Control and Records Management groups at Seattle Genetics. The position will lead the GMP Quality and functional areas in the development and deployment of a new document hierarchy to support the global growth of Seattle Genetics. The position will oversee all day to day activities for the group, as well as represent Quality Systems and Document Management in cross-functional teams to ensure and communicate quality requirements as they relate to Quality Systems. The position will report to the Director of Quality Systems and play a key role in advancing the Document Management function to support a global biopharmaceutical company. Responsibilities: Management oversight of the GMP Document Control and Records Management functions, including the records file rooms, and the electronic document management and records management systems. Develop, revise, and refine the GMP Document hierarchy supporting GMP activities within a growing global biopharmaceutical company. Provide day to day management of staff, including setting of assignments, tracking of deliverables, establishing quality goals in alignment with corporate goals, and setting staff development objectives. Acts as business process owner of GMP Quality electronic systems including but not limited to electronic Document Management System and electronic Records Archive System Supports computer system validations for owned electronic applications Establishes, maintains, trends, and reports on leading and lagging metrics related to area of responsibility. Establishes relationships with key personnel in GMP functions to ensure collaboration, foster cooperation, and ensure positive outcomes. Contributes to the creation and revision of cross-functional policies and procedures ensuring compliance with applicable regulatory requirements, guidances, and industry best practices Works with leaders and staff of GMP functional areas to ensure new or revised policies and procedures are in alignment with company policies and document control hierarchy requirements. Provide regulatory inspection support. Represent Document Management during regulatory inspections, third party/partner audits, and Seattle Genetics internal audits. Review and approve Change Controls, Deviations, and CAPA related to area of responsibility. Applies knowledge of appropriate compliance requirements including ICH guidance, global Health Authority requirements, and industry best practices to guide the development and evolution of the GMP Document Control and Records Management function. Within cross-functional teams, participates on projects impacting multiple GMP locations or areas within a site. Actively seeks out and applies continuous improvements to functional area of responsibility and supported functional areas. Requirements: Requires a minimum of 12+ years' experience in pharmaceuticals or biopharmaceuticals, and at least 3 years of experience in people management Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships Working knowledge of cGMP is required, including ability to understand and apply regulations, guidances and industry best practices to area of responsibility Detail oriented with strong organizational, time, and project management skills Strong written and verbal communication skills Education: A minimum of a bachelor's degree As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114504874

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: The Analytical Sciences Group at Seattle Genetics is seeking an experienced and highly motivated Research Associate to join the mass spectrometry (MS) core group. This person will contribute to product characterization and comparability studies across all stages of clinical development. The ideal candidate will possess hands-on experience with protein mass spectrometry methods and data analysis. Primary responsibilities will include generation and interpretation of MS-based characterization data for monoclonal antibodies (mAbs) and Antibody drug conjugates (ADCs) in support of clinical and commercial programs. Responsibilities: Develop, conduct, and critically interpret experiments aimed at characterizing posttranslationally modified mAbs and ADCs Contribute to technical scientific discussions in group and team meetings Prepare and deliver effective presentations to cross-functional teams Generate and interpret high quality data and technical reports to support various regulatory submissions including IND, BLA, IMPD, etc. Mentor/train other employees and interns as required Requirements: BS. in Analytical Chemistry, Biochemistry or related discipline with 2-5+ years of experience in pharmaceutical or biotech field. Prior experience in research and/or development of recombinant human protein therapeutics is preferred Excellent analytical mindset and skills. Extensive hands-on experience with protein mass spectrometry, chromatographic (e.g. SEC, RP, HIC) and electrophoretic (e.g. CE-SDS, icIEF) techniques and other analytical methods is preferred Good working knowledge of fundamental biopharmaceutical principles including an understanding of protein structure and biochemistry Familiarity with MS data interpretation and analysis software such as MASCOT, Protein Metrics, Proteome Discoverer, or Skyline is a plus A proven problem-solver and team player with strong written and verbal communication skills Strong data and time organization/management skills with attention to details As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114466117

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Program & Portfolio Management . Bothell, Washington Description Summary: Seattle Genetics is seeking a highly motivated and experienced individual who will be responsible for supporting cross-functional drug development activities for high priority, late-stage program(s). This position will partner with program and functional leaders and work in close collaboration with the Global Product Team, sub-teams and co-development partners to advance priority programs. The Senior Program Manager will report directly to the Vice President, Program & Alliance Management. Responsibilities: Work collaboratively and cross-functionally to coordinate, influence and manage efforts to ensure seamless execution of the global product strategy Provide program and project management leadership and support for key functional activities including functional sub-team and working group meeting support, regulatory submission planning and management and/or commercial launch efforts Working in coordination with the Program Team Lead, Global Program Manager and functional leads, develop and maintain high-quality, integrated project plans that align with overall program strategy and drive communication, scenario planning and decision making Facilitate the identification, management and communication of key program risks and their associated mitigation and contingency plans Develop and implement stage appropriate and value-added processes, best practices and tools (integrated timelines, TPPs, stage gate process, governance, core & sub team processes) to increase efficiency and consistency of global product development and team processes/deliverables Leverage strong project and organizational knowledge, leadership and facilitation skills to optimize team meetings and facilitate effective governance and decision making Build and leverage relationships and networks to improve and enhance team dynamics; proactively identifying opportunities and removing obstacles to drive business results Advance program and alliance management best practices and contribute to the operational excellence of Seattle Genetics' Program Management function with a focus on continuous improvement Qualifications: Minimum of 7 years of multi-disciplinary experience in the pharmaceutical/biotech industry, with experience in global cross-functional drug development Late-stage program/project management, regulatory submission planning and/or commercial launch experience highly desirable; track record of successful submission management preferred Drug Development knowledge with understanding of other functions relevant to the position which may include: Research, Preclinical, Clinical, Manufacturing, Regulatory and Commercial Excellent business acumen, demonstrated ability to align teams to strategy to achieve business and project objectives Experience leading and facilitating project team meetings, cross-functional communication and decision making, and ensuring ongoing alignment with internal/external stakeholders A proactive and strategic thinker, with strong facilitation, problem-solving and issue resolution skills Highly collaborative with outstanding communication and relationship management skills, high emotional intelligence Adaptive leadership style with ability to influence teams without formal authority Ability to work effectively with cross-functional teams in a highly matrixed global organization PMP credential and experience with latest PM tools, software and processes highly valued Experience in biologics and oncology, experience working with corporate partners and alliances is desirable Education: Bachelor's Degree required. Advanced degree (MS, MBA, Ph.D.) in biomedical sciences, business or other discipline related to drug development highly preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114439327

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Regulatory Affairs . Bothell, Washington Description Summary: Seattle Genetics is hiring a Sr Manager Regulatory Affairs, come be a part of our exciting growth as we expand our Regulatory team. This position will report to a Director of Regulatory Affairs and have the opportunity to collaborate cross functionally in a scientifically-driven environment and be a part of a team that is successfully delivering a robust pipeline of oncology product to patients. As US regional lead, this position will be responsible for guiding US regulatory strategy for a new product starting with an IND filing onward through registration. In addition, this role will support evaluation of new indications in a later stage marketed product by helping to respond to health authority questions, assisting in creation of meeting materials in support of regulatory interactions, and supporting global clinical trials. The successful candidate will represent Regulatory Affairs on cross-functional teams and mentor a junior regulatory affairs position. Responsibilities: Represent Regulatory Affairs at cross-functional team meetings providing both tactical support and clarity on regulatory expectations and timelines Support initiation of large, global registration trials Prepare, maintain, and/or coordinate complex regulatory submissions in accordance with applicable regulations, including responses to health authority questions and meeting briefing packages Serve as US region lead for an early stage product; responsible for coordinating submission and maintenance of an IND Serve as a resource for more junior members of the team Requirements: Bachelor's Degree in scientific discipline or equivalent; advanced degree desirable Oncology experience is desirable 4+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent; prior experience coordinating responses to regulatory authority questions strongly desired Excellent written and verbal communication skills Able to manage conflicting priorities and adhere to tight timelines Proven ability to work with a high level of integrity, accuracy, and attention to detail Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting Ability to work with minimal oversight International clinical trial experience preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114429421

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Biometrics . Bothell, Washington | South San Francisco, California Description Summary: Seattle Genetics is seeking a Principal Statistical Programmer to join our rapidly growing Biometrics team. You are the ideal candidate for this position if you can drive for results and communicate effectively in a highly collaborative and dynamic environment. In this role, you will design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans. In a leadership role on a study or integration, you will interact with cross functional study teams at a high level to proactively determine programming tasks, timelines, assignments, and resource requirements and oversee study or integration programming efforts to ensure the timely delivery of high-quality outputs according to company and industry standards. You will contribute expertise in the review of case report forms, data management plans, and data set or reporting specifications. As a detail-oriented team member, you will recognize inconsistencies and initiate resolution of data problems when necessary. You may also assist programming management with or be the lead on cross-functional process improvement initiatives and resource allocation. Responsibilities: Develop and validate SAS® programs to produce high quality data sets, tables, figures, and listings within set timelines in accordance with company and regulatory requirements Independently implement complex analysis algorithms for assigned projects or studies Provide statistical programming support for several studies and integrations on a product Ensure compliance with company and industry standards, and contribute to specifications for assigned products based on analysis need and ensure compliance with company and industry standards Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans, table, listing, and figure shells, data management plans, data transfer plans, and case report forms Communicate clearly and proactively with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities Initiate, lead, and participate in planned departmental and cross functional initiatives that facilitate standards, infrastructure, and process enhancements Assist programming management on resource allocation Train and mentor new and junior programmers Requirements: BS and 8+ years of software development and/or programming experience in the biotech, pharmaceutical, medical device, and healthcare industries; MS/PhD and 6+ years of software development and/or programming experience in these industries 5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings and figures for Phase I-IV clinical studies 3+ years of experience in overseeing statistical programming projects 3+ years of experience in writing SAS macros Expert knowledge and understanding of SAS® programming concepts and skills Demonstrated proactivity and strong attention to detail Experience in oncology studies; experience with integrations and electronic submissions preferred Good understanding of and hands-on experience with CDISC, SDTM, and ADaM standards; understanding of electronic submission requirements and guidance preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114375048

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Quality . Bothell, Washington Description Summary: The Sr. Quality Associate, GMP Records Management will be responsible for the day to day oversight, management, and maintenance of the GMP Records filing systems for both physical and electronic records. This position will also be involved in the selection and implementation of Seattle Genetics' electronic records retention system as well as the implementation and management of digitization processes for conversion of physical records to electronic records. Responsibilities: Overall responsibility for the GMP records management program including physical and electronic records. Responsible for file receipt, cataloging, expiration dating, retrieval, and logging of requests Works closely with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in a compliant manner and are readily retrievable Participates in cross-functional teams ensuring implementation, updating, and upgrading of processes and systems related to the management of GMP records Supports GMP regulatory inspections through management of the physical and electronic records. Acts as a subject matter expert during regulatory inspections Mentors junior staff and contractors performing day to day records management activities Owner of the digitization and verification process for converting physical records to electronic records, ensuring compliance with related regulations Oversees reconciliation of completed records issued for GMP activities Identifies and implements continuous improvements with the records management function Stays abreast of changes to regulations, guidances, and industry benchmarks, making recommendations to management as necessary Tracks emerging technologies and recommends changes as necessary Engages with off-site physical and digital storage facilities, ensuring safe and compliant shipping and retrieval of GMP records Writes/revises quality procedures related to the records management process and supporting processes Requirements: Requires a minimum of 8 years' experience in the pharmaceutical and the biopharmaceutical industry working in Quality Assurance Document Control or Records management Demonstrated ability to provide strong customer service to employees at all levels of skill and authority within the company Working knowledge of GMP regulations, guidances, and industry benchmarks related to document and records management Ability to handle changing priorities in a fast-paced environment Strong written and verbal communication skills Highly organized and detail oriented Strong computer skills and working knowledge of MS office applications Education: Requires a minimum of a bachelor's degree As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114371910

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Biometrics . Bothell, Washington | South San Francisco, California Description Summary: Seattle Genetics is seeking a Statistical Programmer II to join our rapidly growing Biometrics team. You are the ideal candidate for this position if you can drive for results and communicate effectively in a highly collaborative and dynamic environment. In this role, you will design, develop, and modify efficient SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans and specifications. You may be asked to provide expertise in the review of case report forms, data management plans, and reporting or data set specifications. You will have the opportunity to act as a liaison between clinical management and study programming teams as needed and write and test programs of moderate complexity. You will bring an analytical mindset to the critical assessment of specifications before implementing them in code and you may also contribute to writing study-level requirements and specifications in line with regulatory and company standards. Responsibilities: Develop and validate SAS® programs on one or more clinical trials or integrations to produce high-quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include datasets, tables, listings and figures Independently implement routine analysis algorithms for assigned project or study Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans, table, listing and figure shells, data management plans, data transfer plans, and case report forms Communicate clearly and proactively with study teams to clarify requirements and specifications, update others on progress, and convey data irregularities Requirements: BS or equivalent relevant education and 3+ years of software development and/or programming experience; MS/PhD and 2+ years of software development and/or programming experience 2 years of programming experience using SAS® in pharmaceutical, biotechnology, medical device, or CRO industries Proficiency in SAS® programming Demonstrated proactivity and strong attention to detail Understanding of CDISC SDTM and ADaM standards Understanding of drug development process As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114325952

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Biometrics . Bothell, Washington | South San Francisco, California Description Summary: Seattle Genetics is seeking a Sr. Statistical Programmer to join our rapidly growing Biometrics team. You are the ideal candidate for this position if you can drive for results and communicate effectively in a highly collaborative and dynamic environment. In this role, you will design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans. You will contribute expertise in the review of case report forms, data management plans, and data set or reporting specifications. You'll liaise between clinical and study programming teams as needed. You will write, test, and assist with the standardization of programs and utilities up to the department level. You will write requirements and specifications with consideration of regulatory and company standards as well as cross-protocol consistency, participate in the creation of study-level documentation, and assist with the setup of new studies. You may also provide support for ongoing regulatory and safety reporting needs for regulatory submissions. Responsibilities: Develop and validate SAS® programs to produce high-quality datasets, tables, listings and figures within set timelines in accordance with company and regulatory requirements Independently implement routine and non-standard analysis algorithms for assigned projects or studies Provide statistical programming support for one or more studies Ensure compliance with company and industry standards; contribute to defining specifications for assigned studies when appropriate Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans, table, listing, and figure shells, data management plans, data transfer plans, and case report forms Communicate clearly and proactively with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities Participate in initiatives that facilitate infrastructure and process enhancements within Biometrics Train and mentor junior programmers Requirements: BS and 7+ years of software development and/or programming experience in the biotech, pharmaceutical, medical device, or healthcare industries; or MS/PhD and 5+ years of software development and/or programming experience in these industries 5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings, and figures for Phase I-IV clinical trials 3+ years of experience in writing SAS macros Advanced SAS® skills Demonstrated proactivity and strong attention to detail Good understanding of and hands-on experience with CDISC, SDTM, and ADaM standards As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114325936

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Regulatory Affairs . Bothell, Washington Description Summary: Seattle Genetics is hiring a Manager, Regulatory Affairs to be a part of our exciting growth as we expand our Regulatory team. The successful candidate will represent Regulatory Affairs on cross-functional teams, working in a collaborative scientifically driven environment to successfully deliver a robust pipeline of oncology products to patients. As a US regional lead, this position will be responsible for guiding US regulatory strategy for a new product starting with an IND filing onward through registration. In addition, this role will support global clinical trials, including preparation of regulatory documentation to health authorities, for a late stage oncology product. Responsibilities: Represent Regulatory Affairs at cross-functional team meetings providing both tactical support and clarity on regulatory expectations and timelines Provide support for large, global registration trials Prepare, maintain, and/or coordinate complex regulatory submissions in accordance with applicable regulations, including responses to health authority questions Serve as US region lead for an early stage product; responsible for coordinating submission and maintenance of an IND Requirements: Bachelor's Degree in scientific discipline or equivalent; advanced degree desirable Oncology experience is desirable 3+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent; prior experience coordinating responses to regulatory authority questions desired Excellent written and verbal communication skills Able to manage conflicting priorities and adhere to tight timelines Proven ability to work with a high level of integrity, accuracy, and attention to detail Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting Ability to work with minimal oversight International clinical trial experience preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114298525

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Information Technology . Bothell, Washington Description Summary: The Service Desk Manager provides oversight for delivery of effective IT customer support services to approximately 2,000 users in local, remote and global locations. The Senior Service Desk Manager is responsible for providing exceptional vision and leadership to a team of technology professionals who are responsible for providing end user technology support services. Responsibilities: Lead the global IT Helpdesk including US and global-based IT staff and 3rd-party IT Support partners. Ensure global coordination on processes and procedures to build consistency and continuity for all employees Plan, design, and analyze Helpdesk process framework according to IT Service Management (ITSM) best practices, while ensuring high level of customer service quality and availability. Establish and meet agreed levels of incident resolution and request fulfillment; continually improve the service desk delivery processes to ensure optimal efficiency of service quality for global customers Ensure the service desk provides and delivers high levels of support for all incidents and requests, providing reports and analysis of service desk performance including customer satisfaction, performance against agreed upon metrics and appropriate improvement plans to reduce end user issues. Publish weekly and monthly reports Manage resource utilization to provide global end user support for desktop, laptop, applications, and related technologies, including the monitoring, tracking, and coordination of Service Desk functions Maintain a customer-service oriented atmosphere for the helpdesk, which includes ensuring prompt response, effective communication and delivery of solutions for reported issues Develop, implement and communicate service desk policies, processes and procedures for the management and support of internal customer requests and impacting incidents Manage ITSM to include system management and maintenance, upgrades, system changes, feature improvements, and knowledgebase administration Assess need for any ITSM tool improvements based on request or incident trends; make recommendations and provide supporting business justification to support associated costs Monitor incident trends and anticipate potential problems for proactive resolution. Ensure case documentation is done systematically in order to build out the knowledge database for quicker resolution to issues Train helpdesk staff on operational procedures, troubleshooting techniques and new hardware/software applications as required. Develop both IT and end user training materials as appropriate Act as an escalation point of contact for problems experienced by end users, troubleshooting, diagnosing and solving issues that arise. Includes direct, over the phone, email, and remote assistance-based support Work collaboratively with cross-functional teams to ensure end user support and training are key deliverables of all deployed solutions. Collaborate with the IT team and other departments in evaluation, selection, and deployment of appropriate tools and applications for corporate deployment Execute and monitor compliance activities within IT Support such as the first and last day of work, software purchasing processes i.e. SOX, HIPAA, Internal Audit, Software license compliance, etc. Additional related duties as assigned Requirements: Expert knowledge of IT systems and customer support operations management Strong working knowledge of help desk operations Advanced ability to lead technology projects for the enterprise (desktop/tablet/smartphones) hardware/ software upgrades Ability to learn new technology and keep abreast of the latest technological advances Strong customer-focus and demonstrated experience working with/meeting business users' requirements Proven service management skills - setting and measuring SLAs and KPIs Ability to efficiently manage multiple initiatives simultaneously Strong interpersonal relationship, team building, collaboration and objective facilitation skills Strong verbal and written communication skills Manage relationship between tier 1 VAR and Seattle Genetics Education: Bachelor's degree in IT or related discipline preferred 10+ years IT operational support experience 7+ years of experience managing IT customer support operations (help desk/service desk/desktop) with 10+ staff As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114262528

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: The Analytical Sciences group at Seattle Genetics is seeking an experienced and highly motivated research associate to support development of therapeutic antibodies and antibody-drug conjugates. This person will play a critical role in method qualification, transfer and troubleshooting, and contribute to product characterization and comparability studies for programs across all stages of clinical development. The ideal candidate will have working knowledge of a variety of analytical techniques, strong critical thinking skills and a demonstrated ability to design, execute, and draw conclusions from experimental studies. The ideal candidate should have a background in analytical biochemistry or related discipline, good interpersonal skills and an ability to work effectively in cross-functional teams to achieve program goals. Responsibilities: Conduct and interpret experiments, generating high quality data for program teams and regulatory filings Perform method qualifications, provide transfer and troubleshooting support to meet program needs and timelines Perform product characterization and method development experiments for off-platform molecules Write technical reports, prepare and deliver effective presentations with minimal guidance Contribute to technical scientific discussions in group and team meetings Troubleshoot instruments and methods, cross-functionally partner with others to resolve analytical issues Mentor/train other employees and interns as required Requirements: 2-5+ years of experience in analytical method development or biomolecular analysis/characterization in a biotechnology/pharmaceutical industry setting Extensive laboratory experience with chromatographic, electrophoretic, and other protein characterization techniques Practical experience in method development, troubleshooting, and qualification Proven ability to design and critically interpret experiments that provide insight into analytical or characterization problems, leveraging scientific literature and general knowledge Ability to perform independently with attention to detail and a commitment to quality Strong organization, time management, and problem-solving skills A team player with desire to achieve both team and individual goals Strong written and verbal communication skills Education: Bachelor's Degree in Biochemistry, Chemistry, Engineering, biological sciences or related field As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114206246

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: The Pharmaceutical Sciences group at Seattle Genetics is seeking a highly motivated research associate to support development of therapeutic antibody-drug conjugates. This person will play a critical role in the formulation and drug product process development of a novel pre-clinical ADC. The ideal candidate will have working knowledge of biologics formulation development and experience in common analytical techniques, as well as strong critical thinking skills and the ability to design, execute, and draw conclusions from experimental studies with managerial guidance. The ideal candidate should have a background in formulation development or analytical biochemistry or a related discipline, good interpersonal skills, and an ability to work effectively in intra-departmental teams to achieve program goals. Responsibilities: Assist with and conduct experiments and analyze results leading to the development of robust formulations for antibody and antibody drug conjugate (ADC) drug substances and drug products Execute studies including pre-formulation characterization, liquid and lyophilized formulation development, stability studies, shipping and handling studies, evaluation of material for use in toxicology and clinical settings Process data and present findings to Pharmaceutical Sciences team and project teams Contribute to technical reports and prepare selected technical reports Assume responsibility for more sophisticated lab equipment as SME Requirements: BS or MS in pharmaceutical sciences, chemistry, biochemistry, biological sciences or a related discipline Minimum of 0-2 years (MS) or 2+ years (BS) of protein formulation or analytical experience in the academic setting or biotechnology/pharmaceutical industry Good problem-solving and critical thinking skills Strong data and time management stills with attention to detail Ability to function as a team player as well as work independently in experimental design, implementation and results interpretation Excellent analytical mindset and skills including hands-on experience with chromatographic (e.g. SEC, RP, CEX) and electrophoretic (e.g. CE-SDS, iCIEF) techniques and other analytical methods Strong fundamental knowledge of protein chemistry, degradation and stabilization mechanisms As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114144028

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: We are seeking a highly motivated individual to join our Potency Assay development team in a full-time position. The Potency Assay development team is responsible for the development, qualification and implementation of cell-based assays, binding assays as well as other methods to support the characterization and advancement of therapeutics in the Seattle Genetics pipeline. The candidate will work with the manager to develop assays and generate data to support several on-going stability and development studies. The successful candidate will have strong data analysis and time organization/management skills with attention to detail with desire to achieve team and individual goals. Responsibilities: Perform various assays, including cell-based assays, ELISAs, and binding assays Participate in general lab maintenance such as stocking, maintaining equipment and buffer preparation Present data at group meetings May be involved in the development of cell-based potency bioassays or binding assays May be involved in the development of reporter cell lines Requirements: Good communication and interpersonal skills are required Function independently as well as actively participate in team responsibilities Meticulous attention to detail, quality and compliance following assay procedures, data reporting and execution of experiments Must be comfortable working in a fast-paced environment and capable of multitasking Accurate and good pipetting ability and knowledge of different types of pipetting techniques required Cell-based assay experience and/or knowledge of theory desirable Previous laboratory experience in a development or GLP or QC setting is desirable Mammalian cell culture experience desirable Experience and/or knowledge of molecular biology and transfection techniques desirable Education: A Bachelor of Science degree in bioengineering, biology, or related field and 2+ years of laboratory experience would be preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114144045

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Sales . Bothell, Washington Description Summary: As part of the sales operations team, the Senior Business Intelligence Analyst will play a key role in the commercial success of Tucatinib and other late-stage pipeline products. This position will support all aspects of business operations for the sales and managed markets teams as it relates to Power BI business intelligence dashboards and reporting. The ideal candidate will be passionate about and highly skilled in creating and maintaining business intelligence dashboards that are simple and action-oriented; resulting in improved sales execution and performance. Must have attention to detail and strong communication skills. Responsibilities: Power BI Dashboards: Develop, enhance, and maintain KPI focused sales and managed markets business intelligence dashboards Dashboard User Support: Communicate to key user groups of dashboards refreshes and changes. Review dashboards with users to assist the team with their everyday dashboard needs. Liaise with IT teams to communicate and troubleshoot dashboard issues and concerns. Respond to dashboard inquiries from the field Queries and Ad-Hoc Reporting: Partner with other commercial team members to understand business needs, propose solutions, and query the data warehouse resulting in the delivery of insightful ad-hoc sales and managed markets reports Data Collaboration: Work cross-functionally with numerous internal teams, such as Marketing, Global Market Insights (GMI), Information Technology, and Finance to deliver accurate and scalable reporting to the business Business Support: Collaborate with Information Technology team members to ensure business processes are in place that enable consistent and accurate loading of data in our commercial data-mart Requirements: 3+ years of practical experience in BI tools in a data rich environment (Power BI, MicroStrategy, Tableau) Must have the ability to create dashboards by mining and extracting key datasets from our business intelligence data mart. Create custom metrics as determined by the business Experience in SQL and ability to query data from SQL database and data cubes preferred Fundamental understanding of SFDC CRM applications (Veeva preferred) Previous experience in pharmaceutical, biotech, or related industry is preferred High level of proficiency with Excel, PowerPoint, Word Education: Bachelor's degree preferred with specialization in Business, MIS, or IT As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI114086997

Manager/Sr. Manager, IT Business Systems Analyst Summary: The IT Manager/Sr. Manager, IT Business Systems Analyst oversees a highly skilled team who will work closely with business partners on system assessments/selection, business process mapping, user requirement definition, tracking, and confirmation of user requirement implementation. Through natural leadership strengths, the manager will contribute to a high-achieving Business Analyst Team and department culture that goes above and beyond to deliver excellent results. Competencies needed to be successful in this role include, but are not limited to, strategic agility, process development & management, planning, building and motivating effective teams, and managing/developing direct reports. The ideal candidate is passionate about people development and is process focused. Responsibilities: Build relationships with business customers who interface with business analyst team Recruit, hire, coach and develop a team of high performing analysts who work with business partners to elicit and document requirements. These include, but are not limited to, business requirements, use cases / user stories, functional requirements, configuration requirements, data and reporting requirements and integration requirements Manage team resource allocation and workload to support current and future business needs Work with leadership to continuously improve system validation (outlined in 21 CFR Part 11) processes and activities required of the team, including but not limited to, authoring requirements and authoring and/or approving report specifications, test plans and other documentation. Monitor and support day-to-day team operations and team performance Design business analysis best practices, develop and maintain department tools, templates, guidelines, scripts and systems. Continuously improve the process Create and ensure adherence to required key metrics, governance and processes that ensure adherence to requirements standards, procedures and quality Work with vendors and own vendor relationships, as needed, to support the business analyst team, work and/or processes Keep current with the latest technology and industry trends; regularly attend training in order to maintain technical and domain expertise Serve as a Subject Matter Expert (SME) for the business analysis function, ensuring staff receive proper training and ongoing support. Track staff usage and understand adoption Requirements: Experience building, managing, and motivating teams, including contract and vendor resources Strong working knowledge of various software programs to manage the teams' functions, including but not limited to Microsoft Office (Word, Excel, PowerPoint, Visio), Smartsheet, and ServiceNow Deep understanding of waterfall and agile methodologies and the ability to efficiently apply the appropriate method as the situation demands Vendor management experience, including but not limited to leading through RFP initiatives, negotiations, and professional service engagements Exceptional planning, coordination and analytical skills Ability to effectively communicate to all levels of leadership throughout the organization Strong written and oral presentation and communication skills Education: Bachelor's degree in computer- or business-related discipline or equivalent job experience required Master's degree, MBA, preferred Certified Scrum Master certification preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. PI114083721