17 jobs found in plainsboro

WuXi AppTec US Job ID 2020-6552 Overview WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. Job Summary Provides technical strategy design and technical guidance to CMC team cross various functions. Conducts effective communication with client team to align CMC strategies and establish agreed technical solutions to encountered challenges. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. Develop positive collaboration relationship with client teams. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Biologic's services in conferences/trade shows. The responsibility will also include new manufacturing site design and operation readiness preparation, and lead assigned function team when manufacture site is alive. Responsibilities Provide project and portfolio leadership supporting IND enabling and late stage product development CMC activities. Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget. Assists with development and manufacturing alliance management, product development and manufacturing strategy Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients Apply industry technical knowledge and experience to support manufacture site design and operation readiness, and lead corresponding function team to support manufacture site operation. Work with a high performance team to ensure best quality services Enhance current service offering and develop new clients Qualifications Technical Skills / Knowledge: Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas. Demonstrates good understanding of the biopharmaceutical industry and biologics molecule drug development. Minimum of 15 years of relevant biopharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. Working knowledge and understanding of current regulations and industry trends for biologics product development, manufacture and testing. Hands-on experience in drug product development program including tech transfer, formulation optimization, process characterization, process validation, filling line and lyophilization development and validation. Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required. Must have working knowledge of MS Office products, especially MS Project. Independence/Accountability: Must be a self-starter, self-motivated, and highly flexible in this homebased position with ~25% travel. Must be organized and detailed-oriented. Problem Solving: Proven experience in creating and carrying out successful plans and processes to solve complex problems. Leadership Activities: Work closely with team members across all CMC related business units and with the WuXi Biologics management team to ensure coordination of all efforts and real-time communication with all stakeholders. Communication Skills: Proficiency in both English and Mandarin is required. Excellent communications skills (verbal, written, and presentation skills). Customary Education and Experience: PhD Chemistry Engineering or related biotechnology discipline Technical experience at Biopharma Industry. Biologics manufacturing experience. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Join our Talent Community so we can keep you informed about upcoming events and opportunities that match your interests. https://careers-wuxiapptec.icims.com/connect PI119353374

WuXi AppTec US Job ID 2020-6549 Overview WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. Job Summary Provides technical strategy design and technical guidance to CMC team cross various functions. Particularly provide consultation and trouble-shooting advices onsite or remotely based on actual data generated from development and manufacturing sites on tech transfer, late stage DP programs including commercial formulation development, drug product process characterization and validation. Serve as functional sponsor to DPD scientists in tech transfer and DP related activities onsite. Conducts effective communication with client team to align CMC strategies and establish agreed technical solutions to encountered challenges. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. Develop positive collaboration relationship with client teams. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Biologic's services in conferences/trade shows. The responsibility will also include new manufacturing site design and operation readiness preparation, and lead assigned function team when manufacture site is alive. Responsibilities Provide project and portfolio leadership supporting IND enabling and late stage product development CMC activities. Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget. Assists with development and manufacturing alliance management, product development and manufacturing strategy Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients Served as technical leader and consultant for minimal 3 months per year in China to provide onsite guidance to DPD teams for various DP related tech transfer, validation and commercial manufacturing issues, as well as regulatory submission. Work with DPD team closely to develop, optimize and implement formulation and drug product manufacturing process development strategy and execution practice. Systematically train DPD project teams to support early and late stage drug product manufacturing process development and validation, and execution skills based on previous knowledge and experience. Join technical leadership team and serve as a technical advisor in building DP formulation and process platforms globally Apply industry technical knowledge and experience to support manufacture site design and operation readiness, and lead corresponding function team to support manufacture site operation based on company project needs. Work with a high performance team to ensure best quality services Enhance current service offering and develop new clients Qualifications Technical Skills / Knowledge: Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas. Demonstrates good understanding of the biopharmaceutical industry and biologics molecule drug development. Minimum of 15 years of relevant biopharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. Working knowledge and understanding of current regulations and industry trends for biologics product development, manufacture and testing. Hands-on experience in drug product development program including tech transfer, formulation optimization, process characterization, process validation, filling line and lyophilization development and validation. Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required. Must have working knowledge of MS Office products, especially MS Project. Independence/Accountability: Must be a self-starter, self-motivated, and highly flexible in this homebased position with ~25% travel. Must be organized and detailed-oriented. Problem Solving: Proven experience in creating and carrying out successful plans and processes to solve complex problems. Leadership Activities: Work closely with team members across all CMC related business units and with the WuXi Biologics management team to ensure coordination of all efforts and real-time communication with all stakeholders. Communication Skills: Proficiency in both English and Mandarin is required. Excellent communications skills (verbal, written, and presentation skills). Customary Education and Experience: PhD Chemistry Engineering or related biotechnology discipline Technical experience at Biopharma Industry. Biologics manufacturing experience. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Join our Talent Community so we can keep you informed about upcoming events and opportunities that match your interests. https://careers-wuxiapptec.icims.com/connect PI119352825

WuXi AppTec US Job ID 2020-6398 Overview The purpose of this position is to manage one or more sites of the company starting in King of Prussia, with possibility of expanding the oversight to multiple sites. Responsibilities Oversee the work during the lab demolition and construction, work with the engineering firm and contractors, provide the oversight and expertise to ensure the work is performed cost-effectively with a good quality. Provide update to the management and escalate if support is needed. Responsible for setting up the King of Prussia lab operation system, including facilities maintenance and laboratory instrument maintenance; environmental safety and health; safeguards and security; cyber and information technology, etc. Installation, maintenance of equipment and facilities, ensuring the operations of utilities and all critical operational systems (WIFI, air handler, DI water, etc.), providing engineering technical support, troubleshoot and support lab equipment (through lab support company). The work may include electrical, plumbing, mechanical, asset management, energy and utilities, controls and automations and general facility maintenance. Provide on-call support if the facility or equipment is set on alarm. Responsible for facility inspections. Ensures facility procedures comply with local, state and federal regulations. Communicates to clients regarding property profiles, emergency preparedness plans, site inspection or audits. Supervise lab support personnel on their day-to-day operations for upstream, downstream and Analytical groups, which may include and not limited to maintaining inventory and procurement of critical lab consumables, assembling critical lab required tubing sets and vessels, cleaning of Bioreactors, etc. Ensure that the laboratory and offices are cleaned and company information are safe Setting up site safety program and ensuring the site personnel and facilities are safe and site operations meet the local township environmental requirements. Work with the engineering firm on the new facility design if needed, provide recommendations to the construction services to achieve cost-effectiveness; evaluate the scope of work in the construction services and the associated cost estimate; provide feedback to the management and engineering firms. Excellent communication and good interpersonal skills, work well with diverse team members Qualifications High school diploma or general education degree (GED) required, associate's or Bachelor's degree in a scientific field preferred; A proven track record of successful facility management leadership experiences; Strong technical knowledge of the following: mechanical, electrical, plumbing, HVAC, structural, safety systems, and energy management; Minimum of 20 years experience in scientific/engineering support roles, preferably operations involving process development, within the biotechnology or pharmaceutical industry Proven project management skills gained within a large pharmaceutical or successful biotechnology company. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352877

WuXi AppTec US-NJ-Plainsboro Job ID 2020-6513 Overview WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. We are seeking an Environmental Health and Safety Specialist II for both our Plainsboro and Cranbury location. Responsibilities Job Summary: Responsible for supporting EHS compliance and risk management within New Jersey. Will develop written programs for each element of EH&S. Essential Job Functions: Recommends improvements in processes, design, procedures, and operating equipment, to minimize the hazardous Develops written programs as needed to clearly define procedures and policy requirements for all EHS program elements. Leads and conducts employee training and emergency preparedness Will develop and maintain a training matrix to define training methods and requirements for all program elements. Assist with EHS audits / inspections, and providing recommendations for corrective actions Assist with EHS management systems development, including drafting of standard operating procedures, guidance documents, and training Assist labs with implementation of SOP's or compliance with existing SOP's. Assist with the management of hazardous waste, including waste characterization, satellite area inspections, and Assist with industrial hygiene related projects, including personal air sampling, indoor air quality assessment, surface wipe sampling, qualitative assessments, etc. Assist with incident and near miss investigations and metric tracking. Be able to understand and articulate the business drivers aligned with safety strategy Qualifications 4+ years of related experience Bachelor's Degree in Engineering or related Science discipline required Environmental Engineering, Environmental Science, Occupational Safety, Industrial Hygiene is preferred Preferred CHMM, CSP, CIH Experience maintaining and managing day-to-day health, safety, emergency response, and environmental compliance and security activities. Previous experience in Environmental, safety, Emergency Response and Haz-Mat. Previous experience implementing policies and procedures that are protective of the environment, personnel, equipment and business interests, including the leading of culture change required to embrace those policy and procedure changes. Experience evaluating, providing advice and implementing solutions due to complexities of health, safety, training and industrial hygiene issues. Experience with radioactivity and formal OSHA & Safety training. Knowledge / Skills / Abilities: Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations. Ability to record data accurately and legibly. Ability to use judgement as dictated by the complexity of the situation. Ability to understand and follow verbal or demonstrated instructions. Ability to work effectively as part of a team and to exhibit effective interpersonal skills. Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication Proficient in Oral & Written communication skills Need to be able to read, write and understand English Proficient in Microsoft (Excel, Word, Outlook) Travel is required 10% , Domestic Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in Lab setting with Biohazards /various Chemicals Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Ability to stand /Sit/walk for long periods of time Ability to Lift 50 lbs occasionally Ability to crouch, bend, twist, and reach Ability to push/pull 50 lbs occasionally Clarity of Vision Ability to identify and distinguish colors Must be able to perform activities with repetitive motions Ability to climb Ladders / Stairs / Scaffolding Ability to work in variable temperatures high to freezing Inside/outside working conditions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352497

WuXi AppTec US Job ID 2020-6528 Overview WuXi Biologics provides a comprehensive, integrated and highly customizable range of services for the discovery, development and manufacturing of biologics. We are looking for an Executive Director to lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Biologics' services in conferences/trade shows. Responsibilities • Provide project and portfolio leadership supporting IND enabling and late stage product development CMC activities. • Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget. • Assists with development and manufacturing alliance management, product development and manufacturing strategy. • Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients. • Work with a high performance team to ensure best quality services • Enhance current service offering and develop new clients. Qualifications Experience / Education • Ph.D. in Bio/Chemistry, Bio/Chemical Engineering or related discipline, MBA. • Technical experience in large pharma or biotech companies • Biologics development and manufacturing experience. Knowledge / Skills / Abilities: • Proficient in Microsoft Office (Project, Excel, Word and Outlook). • Travel is required ~25%- Domestic and International, Daily/Overnight. • Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas. • Demonstrates good understanding of the pharmaceutical industry and biologics drug development. • Minimum of 10 years of relevant pharmaceutical or biotech industry experience in biologics CMC development and/or GMP manufacturing. • Working knowledge and understanding of current regulations and industry trends for biologics and Antibody-Drug Conjugate (ADC) product development, manufacture and testing. • Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required. Independence/Accountability: • Must be organized and detailed-oriented. Problem Solving: • Proven experience in creating and carrying out successful plans and processes to solve complex problems. Leadership Activities: • Work closely with team members across all CMC related business units to ensure coordination of all efforts and real-time communication with all stakeholders. Communication Skills: • Fluent in both English and Mandarin is • Excellent communications skills (verbal, written, and presentation skills). Physical Requirements: • Ability to stand /Sit/walk for long periods of time • Ability to Lift 10 lbs routinely • Ability to crouch, bend, twist, and reach • Ability to push/pull 10 lbs routinely/ often / occasionally • Clarity of Vision An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability PI119352560

WuXi AppTec US-NJ-Plainsboro Job ID 2019-6004 Overview WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. We are seeking a System Administrator & Compliance individual within our Information Technology department located between both Plainsboro & Cranbury, NJ. Responsibilities Job Summary: This position supports the Laboratory software systems and associated software systems, for the Plainsboro/Cranbury, NJ sites. The position will also be involved with implementing and upgrading of these specific systems. Essential Job Functions: To be responsible for the day to day support of IT infrastructure of regulated systems. To be the central point of contact for all regulated system support issues reported to the IT helpdesk. Work with the QA and Validation team as required. To respond to emergency requests for support in a timely manner and escalate appropriately. Under change management processes provides support of preparing, reviewing, approving, and implementing system changes and enhancements. Drive necessary improvements in IT infrastructure related to the laboratory system applications to improve the overall efficiency and effectiveness. Meet regularly with IT/QA/Validation/end-users to analyze their processes and needs and employ comprehensive knowledge to assist in decision making. Interface with sponsor and regulatory audits as directed by IT management Responsible for regulated systems user management, security management, backup/restore, and disaster recovery. Maintain records and documentation for areas of responsibility as required by SOPs Responsible for the technical support during the computerized system issue trouble shooting. Participate in the on-call system for IT support, and adhere to flexible working arrangements as necessary. Qualifications Job Requirements Experience / Education: BS in computer science, EE, relevant science major. Possesses 2-4 years (preferably 3-5 years) experience in a laboratory environment Understanding of GLP, and 21 CFR part 11 for validated electronic data systems in a laboratory environment Previous experience in Applications and Systems administration in a pharmaceutical lab environment a huge plus. Well organized, able to work on multiple projects. Demonstrated knowledge of and experience with SDLC/Validation and system life cycle methodology preferred. Experience with data analysis. Skills and experience working in culturally diverse, multi-disciplined work groups with the ability to manage multiple priorities and be self-directed in a fast paced environment Familiar with GLP, FDA, 21 CFR Part 11 is required. Solid knowledge with Windows and Windows server technology, and network. Knowledge / Skills / Abilities Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Excellent interpersonal skills Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint, and other applicable software Ability to work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Ability to work in a team environment Familiarity with and adherence to regulatory guidelines consistent with XBL requirements Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals Must not have animal allergies to applicable species in this facility Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Ability to stand /Sit/walk for long periods of time Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs routinely/ often / occasionally Clarity of Vision Ability to identify and distinguish colors Must be able to perform activities with repetitive motions Ability to climb Ladders / Stairs / Scaffolding Ability to work in variable temperatures high to freezing Inside/outside working conditions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352387

WuXi AppTec US Job ID 2020-6304 Overview • Responsible to provide strong Strategic Account management within the West Coast North America sales territory. • Ability to sell services across the WuXi Biologics value chain. • Development, where required, of new potential strategic accounts • Works closely with the Bio leadership team and operations to develop the right strategies and tactics to meet the yearly revenue targets for the region • Stays current on competitors and competitive strategies and provides input needed for the development of future services and products. • This position should be based on the West coast, ideally close to Seattle, Washington Responsibilities Achieve West coast regional sales target Grow revenue through cross selling into exiting strategic accounts, across WuXi Biologics value chain. Managing the portfolio of customers Working and aligning with local CMC lead for each account Plans and performs the selling, proposal and contract negotiation process independently Builds strong internal relationships across functions Represents WuXi Biologics at key trade shows Contributes to key commercial strategies across the sales team Responsible for managing all aspects of the customer relationship. Delivering Exemplary customer service Timely update of CRM and monitoring of KPIs Qualifications • Minimum of Bachelor's degree. MBA or PhD preferred but not required. • At least 10+ years life science experience. • At least 5-10 years of successful sales and territory management experience within the CMO / CRO space. • Strong written and oral communication skills. • Strong gravitas and relationship building skills • Listening and empathy demonstrated • Demonstrated ability to work under pressure. • Demonstrated success at managing multiple opportunities and projects simultaneously. • Ability to work effectively as part of a team and to exhibit effective interpersonal skills. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352256

WuXi AppTec US-NJ-Plainsboro Job ID 2020-6499 Overview WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. We are seeking an IT Systems Administrator and Business Analyst within our IT Group located in Plainsboro, NJ. Responsibilities Job Summary: This position supports the Laboratory software systems and associated systems for the Plainsboro/Cranbury, NJ sites. The position involves implementing and upgrading these specific systems. The position will also involve evaluating business processes, identifing requirements and implementing new solutions. Essential Job Functions: Responsible for the day to day support of IT infrastructure of regulated systems. Central point of contact for all regulated system support issues reported to the IT helpdesk. Work with the QA and Validation team as required. To respond to emergency requests for support in a timely manner and escalate appropriately. Provides support under change management processes for preparing, reviewing, approving, and implementing system changes and enhancements. Drive necessary improvements in IT infrastructure related to the laboratory system applications to improve the overall efficiency and effectiveness. Meet regularly with IT/QA/Validation/end-users to analyze their processes and needs and employ comprehensive knowledge to assist in decision making. Interface with sponsor and regulatory audits as directed by IT management Responsible for regulated systems user management, security management, backup/restore, and disaster recovery. Maintain records and documentation for areas of responsibility as per SOPs. Responsible for technical support during computerized system trouble shooting. Participate in the on-call system for IT support, and adhere to flexible working arrangements as necessary. Interact with the business stakeholders and subject matter experts in order to understand their problems and needs. Collecting and analyzing data for potential business needs and requirements. Identifying specific business opportunities. Influencing stakeholders to support business projects. Leading and coordinating projects to produce better business outcomes. Testing business processes and recommending improvements. Qualifications Experience / Education: BS in computer science, EE, relevant science major. Possesses 2-5 years (preferably 3-6 years) experience in a laboratory environment. Understanding of GxP, and 21 CFR part 11 for validated electronic data systems in a laboratory environment Previous experience in Applications and Systems administration in a pharmaceutical lab environment. Previous experience in Business Analysis is a huge plus. Well organized, able to work on multiple projects. Demonstrated knowledge of and experience with SDLC/Validation and system life cycle methodology preferred. Experience with data analysis. Skills and experience working in culturally diverse, multi-disciplined work groups Ability to manage multiple priorities and be self-directed in a fast paced environment Solid knowledge with Windows and Windows server technology, and network. Knowledge / Skills / Abilities Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Excellent interpersonal skills Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint, and other applicable software Ability to work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Ability to work in a team environment Familiarity with and adherence to regulatory guidelines and SOPs Understanding objectives and being able to interpret directions is important Ability to run stakeholder meetings with excellent presentation skills Good listening and time management skills Good documentation and writing skills Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals Must not have animal allergies to applicable species in this facility Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Ability to stand / sit / walk for long periods of time Ability to crouch, bend, twist, and reach Ability to push / pull 10 lbs. routinely / often / occasionally Clarity of Vision Ability to identify and distinguish colors Must be able to perform activities with repetitive motions Ability to climb Ladders / Stairs / Scaffolding Ability to work in variable temperatures high to freezing Inside / outside working conditions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352354

WuXi AppTec US-NJ-Plainsboro Job ID 2020-6551 Overview WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. We are seeking a Senior Scientist I within our Bioanalytical - Small Molecule Group located in Plainsboro, NJ. Responsibilities Job Summary: The Senior Scientist I will hold the role of Principal Investigator/Study Director and is primarily responsible for the preparation, conduct, and administration of the bioanalytical portion of a study at WuXi AppTec in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research. Essential Job Functions: Designs, plans, and carries out research and project development with limited supervision. Independently devises experimental studies in accordance with GLP, EPA, FDA, and OECD or other applicable regulations. May independently devise procedures or studies to search out causes and remedies for problems. Performs and/or oversees work to attain objectives. Supervises other research personnel, as appropriate. Compiles, records, calculates, and analyzes data in accordance with accepted standards and practices. Interprets significance of results and draws conclusions. Writes comprehensive reports, recommending application of finings, and presents clear and concise oral reports of processes and accomplishments. Assumes complete responsibility for assigned projects, such as acting as study director/ principal investigator, and assumes a continuing responsibility for contributing ideas related to this area of investigation. Maintains professional contact with developments in the environmental, metabolism chemistry, and/or pharmaceutical areas. May act as a project coordinator. May serve as a contact for the sponsor. Guides and counsels employees in order to contribute to the goals of the company and to encourage personal growth. Follows company's safety policies, practices and procedures in order to maintain a safe work environment. Other duties as assigned. Qualifications Experience / Education: D. degree in chemistry, biology, or a related discipline, or equivalent Post-doctoral experience is desirable Any similar combination of education and experience Knowledge / Skills / Abilities: Experience with small molecule LC-MS/MS analysis and interpretation. Experience in method development utilizing various techniques Experience in unitizing liquid handlers for sample analysis and aliquotting. Knowledge of various plat forms of MS/MS as Analyst and MassLynx Experience and knowledge of Good Laboratory Practices (GLP). Highly skilled in conducting research, data interpretation and report writing. Knowledge of utilizing Laboratory Information Management System (LIMS). Relevant industrial experience will be an advantage. Experience in trouble shooting LC-MS/MS equipment. Experience in trouble shooting analytical methods on timely fashion Physical Requirements: Must be able to work in an office environment with typical noise conditions. Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Must be able to stand/sit/walk for long periods of time Must be able to Lift up to 20 lbs routinely Must be able to crouch, bend, twist, and reach Must be able to push/pull up to 20 lbs routinely/ often / occasionally Must be able to perform activities with repetitive motions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352133

WuXi AppTec US-NJ-Plainsboro Job ID 2020-6423 Overview WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life. Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. We are seeking a Watson LIMS Specialist within our Bioanalytical Group located in Plainsboro, NJ. Responsibilities Job Summary: The Watson LIMS Specialist will independently conduct of a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a GLP regulatory laboratory environment. The employee is responsible for the scientific excellence, project management as well as client relationship development. Essential Job Functions: Plans and carries out experiments and associated research assignments. Able to set up the study and using the proper technique/software to carry the experimental phase to completion. Prepare data summary tables for report. Efficient time management to complete the assigned task May serve as principal investigator. Operates and/or oversees the operation of equipment to acquire experimental data. Designs, modifies, constructs, calibrates, and maintains equipment. Compiles, calculates, plots, and analyzes, and with experience, interprets data; records and maintains data in accordance with accepted standards and practices. Assumes responsibility for technical accuracy of work. Thorough understanding of Good Laboratory Practices and EPA, FDA, or other regulations pertaining to the study. Maintains and enhances technical expertise and knowledge of environmental, metabolism chemistry, and/or pharmaceutical areas. Identifies safety hazards and initiates corrective action. Assists in the safety training for subordinates and/or less experienced staff. Assists in training Associate Scientists Follows company's safety policies, practices and procedures in order to maintain a safe work environment Other duties as assigned. Qualifications Job Requirements Experience / Education: Bachelor's degree in chemistry, biology, or a related discipline 4-6 years of relevant experience with advanced responsibilities in research and development, or work equivalent experience. Any similar combination of education and experience Knowledge / Skills / Abilities: Knowledge of commonly used concepts, practices, and procedures within biological or chemical R&D laboratory setting Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Effective interpersonal skills Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint Knowledge of Laboratory Information Management System (LIMS) Knowledge of Data Acquisitions and Operating Software as Analyst, MassLynx. Ability to work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Ability to work in a team environment Familiarity with and adherence to regulatory guidelines consistent with company requirements Physical Requirements: Must be able to work in an office environment with typical noise conditions. Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Must be able to stand/sit/walk for long periods of time Must be able to Lift up to 20 lbs routinely Must be able to crouch, bend, twist, and reach Must be able to push/pull up to 20 lbs routinely/ often / occasionally Must be able to perform activities with repetitive motions An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352156

WuXi AppTec US Job ID 2020-6512 Overview WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. Job Summary: Responsible to provide strong Strategic Account management within the East Coast North America sales territory. Development, where required, of new potential strategic accounts Ability to grow the East coast region, with the current business development team, across Strategic Accounts Works closely with the Bio leadership team and operations to develop the right strategies and tactics to meet the yearly revenue targets for the region Stays current on competitors and competitive strategies and provides input needed for the development of future services and products. This position should be based on the East coast, ideally Boston, New York, Philadelphia Responsibilities Conduct business development activities for Biologics Discovery (including Platform/technology Licensing) Develop new potential customers and maintain existing customers with customer scouting, customer exploration, business introduction, contract negotiation, sales following-up, and managing all aspects of the customer relationship independently Collect market intelligence with information gathering and trend analysis on the industry, pricing, and competition. Collect, analyze and track competitors' information and business move, help make Discovery strategic plan Managing the portfolio of customers Builds strong internal relationships across functions Represents WuXi Biologics at key trade shows Contributes to key commercial strategies across the sales team Delivering Exemplary customer service Timely update of CRM and monitoring of KPIs Qualifications Advanced degree in Science is desired (e.g. PhD, MBA) or commensurate experience 7+ years of experience in life science industry Experience in active listening and engaging with stakeholders Strong written and oral communication skills. Strong gravitas and relationship building skills Demonstrated ability to multi task in a fast paced environment Ability to work effectively as part of a team and to exhibit effective interpersonal skills. PI119352183

WuXi AppTec US Job ID 2020-6348 Overview Responsible to provide strong Strategic Account Management within the East Coast North America sales territory. Development, where required, of new potential strategic accounts Ability to grow the East Coast region, with the current business development team, across Strategic Accounts Works closely with the Bio leadership team and operations to develop the right strategies and tactics to meet the yearly revenue targets for the region Stays current on competitors and competitive strategies and provides input needed for the development of future services and products. This position should be based on the East Coast, ideally in the greater areas of Boston, New York, Philadelphia. Responsibilities Achieve East Coast regional sales target Grow revenue through cross selling into exiting strategic accounts, across WuXi Biologics value chain. Managing the portfolio of customers Working and aligning with local CMC Lead for each account Plans and performs the selling, proposal and contract negotiation process independently Builds strong internal relationships across functions Represents WuXi Biologics at key trade shows Contributes to key commercial strategies across the sales team Responsible for managing all aspects of the customer relationship. Delivering Exemplary customer service Timely update of CRM and monitoring of KPIs Qualifications Minimum of Bachelor's degree. MBA or PhD preferred but not required. At least 10+ years life science experience. At least 5-10 years of successful sales and territory management experience within the CMO / CRO space. Strong written and oral communication skills. Strong gravitas and relationship building skills Listening and empathy demonstrated Demonstrated ability to work under pressure. Demonstrated success at managing multiple opportunities and projects simultaneously. Ability to work effectively as part of a team and to exhibit effective interpersonal skills An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119352210

WuXi AppTec US Job ID 2020-6548 Overview STA Pharmaceuticals, a WuXi AppTec Company, has an exciting opportunity for an Associate Director, CMC Regulatory Affairs. Associate Director, CMC Regulatory Affairs operations management, reports to Senior Director, the head of Regulatory CMC and is responsible for leading projects and providing support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed products, including small molecules, oligonucleotides, and peptides modalities. Responsibilities The Associate Director is works closely with subject matter experts and is responsible for assuring the regulatory CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are of high quality and on time. This position ensures cross-functional alignment between WuXi STA analytical, drug substance and product teams to ensure that clients' needs are addressed in a timely fashion, while within the scope of regulatory guidelines Primary Responsibilities Include: Serves as Regulatory CMC project manager. Assesses and communicates CMC Regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Serves as the Regulatory representative for assigned projects at WuXi STA internal meetings as well as at meetings and communications with clients. Develops and manages timelines and deliverables. Performs other related duties as assigned. Qualifications Education and Skills Requirements: Bachelor's degree required, M.S. or Ph.D., in chemistry or engineering, with at least 7 years of pharmaceutical development experience (or 5+ years with M.S. or 3+ years with Ph.D.). Prior experience in preparing INDs, IMPDs, NDA and/or MAA submission(s) is a plus. Experience working on cross-functional teams and good interpersonal skills are required. Strong team player that is solution oriented. Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly. Proficiency with Microsoft Office Applications; Word, Excel, Outlook and functional systems. Physical Requirements: Ability to stand /Sit/walk for long periods of time Ability to Lift 10 lbs routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs routinely/ often / occasionally An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability PI119189119

WuXi AppTec US Job ID 2020-6550 Overview STA Pharmaceuticals, a WuXi AppTec Company, has an exciting opportunity for an Associate Director, US Project Management . This position will be responsible for managing projects within STA, WuXi's API development and manufacturing division. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA's services in conferences/trade shows. Responsibilities Essential Job Functions: Prepare Quotations/Proposals with inputs from key stakeholders. Participate in the planning and implementation of project. Establishes project objectives, timelines and deliverables. Defines project tasks and resource requirements. Drive the project and closely monitor/control project progression to ensure project is completed on schedule and within budget. Reports project progress to all key stakeholders. Support technical team to investigate potentially serious situations and implements corrective measures. Serves as liaison with client contacts, manages day-to-day communications. Represents company in project meetings, prepares meeting agenda and minutes, and follow through action items. Evaluates and assesses project results, provides recommendations for future improvements. Provides support to business development team to attend customer visits, conferences or tradeshows. Qualifications Job Requirements: Experience / Education Masters (MS) or PhD in chemistry A minimum of 5 years pharmaceutical or CRO/CMO industry experience preferably in process R&D, API development and manufacturing area. Prior experience in project management or managing external research collaborations. Knowledge / Skills / Abilities: Technical Skills / Knowledge: Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas. Demonstrates good understanding of the pharmaceutical industry and small molecule drug development process Minimum of 5 years of relevant pharmaceutical or biotech industry experience in process development and/or API manufacturing. Experience in Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required. Independence/ Accountability: Must be a self-starter, self-motivated, highly flexible. Must be organized and detailed-oriented. Problem Solving: Proven experience in creating and carrying out successful plans and processes Leadership Activities: Work closely with team members in the business units and the project management team to ensure coordination of efforts and ensure good communication with all parties. Communication Skills: Proficiency in both English and Mandarin is required. Excellent communications skills (verbal, written, and presentation skills). Ability to use all Microsoft Office products Physical Requirements: Ability to stand /Sit/walk for long periods of time Ability to Lift 10 lbs routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs routinely/ often / occasionally An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119189103

WuXi AppTec US Job ID 2020-6520 Overview Responsible for providing research solutions to meet partner's needs via closely working with the Research Services Division Business Development team in the US (East Coast) and Scientific Operations team in China. Responsibilities • Provide scientific strategy and solutions to clients via face-to-face or/and online engagement • Closely work with Business Development and Scientific operations teams to jointly develop and win business via research proposals • Build and maintain business relationship with clients • Provide timely feedback to Scientific operations team regarding future science and technology directions Qualifications • Ph.D or/and MD in biomedical discipline • At least 8-year industry / academic experience in drug discovery and/or translational research in cancer, autoimmune disease or/and rare genetic disease • Excellent interpersonal skills • Willingness for domestic business travels • Drug discovery or/and industry experience is preferred • Strong leadership skills as applied to inter- and intra-departmental teams. • Proven ability to build strong, trusting, working relationships. • Outstanding verbal and written communication skills as well as strong presentation skills • Ability and desire to work in a team-oriented environment Knowledge / Skills / Abilities: • Proficient Oral & Written communication skills in both English and Mandarin • Proficient in Microsoft (Excel, Word, Outlook) Physical Requirements: • Ability to stand /Sit/walk for long periods of time • Ability to crouch, bend, twist, and reach • Ability to travel via plane or train An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119151554

WuXi AppTec US Job ID 2020-6526 Overview Responsible for providing research solutions to meet partner's needs via closely working with the Research Services Division Business Development team in the US (West Coast) and Scientific Operations team in China. Responsibilities • Provide scientific strategy and solutions to clients via face-to-face or/and online engagement • Closely work with Business Development and Scientific operations teams to jointly develop and win business via research proposals • Build and maintain business relationship with clients • Provide timely feedback to Scientific operations team regarding future science and technology directions Qualifications Experience / Education • Ph.D or/and MD in biomedical discipline • At least 8-year industry / academic experience in drug discovery and/or translational research in cancer, autoimmune disease or/and rare genetic disease • Excellent interpersonal skills • Willingness for domestic business travels • Drug discovery or/and industry experience is preferred • Strong leadership skills as applied to inter- and intra-departmental teams. • Proven ability to build strong, trusting, working relationships. • Outstanding verbal and written communication skills as well as strong presentation skills • Ability and desire to work in a team-oriented environment Knowledge / Skills / Abilities: • Proficient Oral & Written communication skills in both English and Mandarin • Proficient in Microsoft (Excel, Word, Outlook) Physical Requirements: • Ability to stand /Sit/walk for long periods of time • Ability to crouch, bend, twist, and reach • Ability to travel via plane or train An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. PI119151301

Job Code: 10897 Location: 724 School Brand: Montessori Corner City: Plainsboro School State: NJ Montessori Corner Plainsboro, New Jersey Our school builds the solid academic foundation students need for future success. In our school, classes are led by dedicated, caring teachers who value open communication with parents. Using our Montessori curriculum, our school offers the perfect balance of learning and play, combining structured learning experiences with play activities designed for each developmental stage. If you value a career in an educational community of extraordinary professionals, join ours! This position is 10:30 am - 6:30 pm with a pay range of $12-$16 an hour. We are currently looking for a caring and energetic Preschool Assistant Teacher to join our team. If you have a passion for working with children, are dedicated to providing the best education and care to your students, work collaboratively, and want to learn and grow, we want you to be a part of our team. JOB DUTIES: Create, manage and participate in a variety of learning environments and activities that provide opportunities for students to develop to their fullest potential and achieve their learning objectives. Assist the Lead Teacher to create and deliver lesson plans, implement school curriculum, and assess developmental needs of students. Maintain a healthy and safe environment. Communicate positively with students, parents and staff. Participate collaboratively and professionally with other teachers and staff to promote the general well-being of the school, and collective/individual interest of its staff and student body. This position is 10:30 am - 6:30 pm with a pay range of $12-$16 an hour. ESSENTIAL SKILLS & EXPERIENCE: High School diploma (equivalent GED) required. Bachelors degree preferred. One year of experience.Two-year degree in Early Childhood Education preferred. Previous experience in a licensed preschool or early development center. Strong interpersonal and communication skills. Must be 18 years of age or older. This position is 10:30 am - 6:30 pm with a pay range of $12-$16 an hour. BENEFITS FOR ELIGIBLE EMPLOYEES: Competitive pay. Medical, dental, and vision insurance. Company paid life insurance; supplemental life insurance available. A 401(k) plan with matching employer contributions. Paid vacation, holidays, and sick time. Childcare tuition discounts. Flexible spending plans for both medical and dependent care. Educational assistance. This position is 10:30 am - 6:30 pm with a pay range of $12-$16 an hour. The company is an Equal Opportunity Employer. M/F/D/V encouraged to apply.* PS18 PI118580843