Cambrex - Charles City

Overview The Senior Scientist III will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks. Responsibilities Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control. Perform analytical chemistry assays based on new and existing methodologies Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer Write technical reports to document analytical methods Maintain laboratory notebooks documenting...

Overview Position is directed toward optimization of existing chemical routes and development of alternate chemistry toward key synthetic intermediates and APIs. Carries out multistep chemical synthesis and product isolation/purification operations in the laboratory, independently or as part of an integrated team. Chemist utilizes modern analytical tools to determine identity and purity of products made during projects. Communication with clients in regular team meetings; prepares R&D reports at the conclusion of projects. Responsibilities   â–º Carry out multistep organic syntheses, isolation, and purification of targeted products under supervision or direction of a senior member of the team.   â–º Must possess a basic understanding of modern organic synthesis methodologies.   â–º The chemist must have a fundamental understanding of modern analytical and spectroscopic techniques and may possess the ability to interpret the corresponding data and spectra....

Overview Position is directed toward optimization of existing chemical routes and development of alternate chemistry toward key synthetic intermediates and APIs. Carries out multistep chemical synthesis and product isolation/purification operations in the laboratory, independently or as part of an integrated team. Chemist utilizes modern analytical tools to determine identity and purity of products made during projects. Communication with clients in regular team meetings; prepares R&D reports at the conclusion of projects. Responsibilities Carry out multistep organic syntheses, isolation, and purification of targeted products under supervision or direction of a senior member of the team.Must possess a basic understanding of modern organic synthesis methodologies.The chemist must have a fundamental understanding of modern analytical and spectroscopic techniques and may possess the ability to interpret the corresponding data and spectra.Must demonstrate a proficiency to...

Overview The   Monday   through Friday   Utility Mechanic P osition,   serves as the technical lead for utility-related projects, equipment installations, facility improvements, and reliability initiatives across the site. This position   is   Monday-Friday 8-hour s , overtime as   needed,   to   provide dedicated support for planned maintenance, capital projects, system upgrades, and continuous improvement efforts .   The position also serves   as a technical resource for the maintenance team .     Unlike shift utility mechani cs w ho primarily respond to operational needs and equipment failures, this role focuses on proactive planning, project execution, equipment reliability, and long-term asset performance.   Responsibilities Project Leadership   Lead utility-related capital and maintenance projects from planning through completion.    Coordinate installation, startup, and commissioning of new equipment....

Overview The Senior Scientist II will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks. Responsibilities Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control. Perform analytical chemistry assays based on new and existing methodologies Operate analytical instrumentation such as HPLC, GC, FTIR, Titrator, Particle Size Analyzer Write technical reports to document analytical methods Maintain laboratory notebooks documenting work...

Overview The Production Operations Coordinator provides administrative, documentation, data management, and operational support to the Production department. This role is responsible for maintaining accurate production records and data in SAP, coordinating the movement and review of batch records between Production and Quality Assurance, tracking operational discrepancies and metrics, and supporting inventory and documentation processes. The position plays an important role in ensuring production records are accurate, complete, and available for timely QA review and approval. The role also supports department reporting, document control, inventory activities, controlled substance recordkeeping, and pre-campaign readiness activities. Success in this position requires a high level of attention to detail, organization, accuracy, follow-through, and the ability to work effectively with Production, QA, and other site functions in a regulated manufacturing environment....

Overview As a part of the Engineering Department, the Automation Engineer will support and   maintain   the plant wide Distributed Controls System (DCS), standalone   PLC’s   and plant alarm system .    Interaction with all areas of the manufacturing plant site will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines.    Responsibilities Provide automation support for Operations, Quality Assurance,   Information Technology,   Maintenance ,   and Pro duction   Engineering to ensure a safe and efficient facility to produce quality materials.   Lead / assist facility designs or modifications as it relates to automation and alarm system needs.  This may include control panel design, network architecture, computer systems , other   as needed.   Perform necessary automation / engineering functions to support project related design work and project capital requests....

Overview The Production Engineer will be a Operations technical expert and responsible for reviewing documentation for Operations to implement projects for the manufacture of APIs, bulk intermediates, and other products from development through piloting and/or commercial production. Responsibilities Writing batch records and cleaning records for commercial products or simple revisions, campaign reports, as needed to support production operations. Initiate SOPs and investigations/deviation reports/CAPAs for production operations and commercial products. Reviewing and approving documentation (batch records, cleaning records, supplements, etc) for Operations as the area technical expert. Troubleshoot equipment and coordinate with maintenance to monitor equipment for efficiency improvement. Assist Process Engineers and Chemical Development teams when new processes are transferred into the area workcenter. Work with Validation Engineering and Maintenance departments on...

Overview The Production Operations Coordinator provides administrative, documentation, data management, and operational support to the Production department. This role is responsible for maintaining accurate production records and data in SAP, coordinating the movement and review of batch records between Production and Quality Assurance, tracking operational discrepancies and metrics, and supporting inventory and documentation processes. The position plays an important role in ensuring production records are accurate, complete, and available for timely QA review and approval. The role also supports department reporting, document control, inventory activities, controlled substance recordkeeping, and pre-campaign readiness activities. Success in this position requires a high level of attention to detail, organization, accuracy, follow-through, and the ability to work effectively with Production, QA, and other site functions in a regulated manufacturing environment....

Overview As an Associate Engineer at Cambrex, you’ll launch your career in chemical engineering with the support of highly experienced engineers and scientists who are eager to mentor and guide you. In this role, you’ll be immersed in every stage of bringing new products from the laboratory to full-scale manufacturing, gaining hands-on experience with batch processes and unit operations such as reactions, distillation, extraction, filtration, and drying. Under supervision of the department manager, the Associate Engineer will rotate through several key engineering roles such as Process, Production, Validation, Project, Environmental and Reliability in an approximate two-year period.  The purpose of the Associate Engineer position is to provide recent college graduates with the opportunity to gain a broad overview of the core functions that are critical to the manufacturing and engineering support functions at Cambrex. Responsibilities Process Engineering (6 -12 months)...

Overview As a Process Engineer II, you’ll build on your chemical engineering experience while continuing to receive mentorship from senior engineers and scientists who support your professional growth. In this role, you’ll operate with increasing independence, contributing your expertise across all stages of bringing new products from the laboratory to full-scale batch manufacturing. You’ll gain hands-on experience with diverse processes and unit operations such as reactions, distillation, extraction, filtration, and drying, while also beginning to lead small to moderate projects. As part of a global contract development and manufacturing organization, you’ll have the opportunity to collaborate directly with pharmaceutical clients worldwide and to work on multiple processes each year. This position offers clear pathways for career development, whether you choose to specialize in technical expertise, project leadership, or operations. Over time, you’ll have opportunities to...

Overview Reporting to the Shift Supervisor, the Scientific Manufacturing Operator is responsible for safely operating and monitoring pharmaceutical manufacturing equipment used in the production of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates. This role combines scientific knowledge with hands-on manufacturing operations in a current Good Manufacturing Practice (cGMP)-regulated environment. The Scientific Manufacturing Operator will operate reactors and supporting process equipment, perform in-process testing, monitor production parameters, troubleshoot equipment and process issues, and ensure all activities are documented in accordance with cGMP requirements. This is a career-entry scientific manufacturing role that provides recent graduates with an opportunity to apply their scientific or engineering education in a large-scale pharmaceutical manufacturing environment while developing technical expertise in API manufacturing processes....

Overview The Production Supervisor will be expected to supervise operating personnel for   safe,   efficient,   and profitable operation of the chemical manufacturing area. The incumbent will   be responsible for   administration of   day-to-day   manpower ,   equipment   and processing needs of the plant site. The Production Supervisor will work closely with all departments to ensure   timely   shipme nt of quality products,   meeting   or exceeding customer expectations.  Shift work   is   required .   Responsibilities Ensuring assigned production area meets or exceeds all safety and quality requirements    Scheduling operations in a manner that prevents delays and efficiently   utilize s   manpower     Ensuring adherence to Standard Operating Procedures in all operations and activities    Ensure employees are   properly trained   and evaluate   their   performance    Exercising proper care in...

Overview The Chemist I in Quality Control is responsible for performing a variety of chemical analyses to ensure the release of raw materials, intermediates, and finished products. The role requires adherence to EPA, FDA, cGMP, cGLP, and DEA regulations, as well as company SOPs. The Chemist I also contributes to the development and maintenance of laboratory programs, such as stability testing, calibration, and preventive maintenance, and participates in method development and troubleshooting for analytical instruments. The position involves handling hazardous materials, conducting statistical evaluations of data, and providing on-call support as needed. Responsibilities Adhere to all EPA, FDA, cGMP, cGLP DEA regulations and internal SOP's as they relate to the operation of the Quality Control lab and general operation of the chemical production facility Follow all OSHA and company safety rules and practices Data review Data entry Perform a wide variety of chemical...

Overview The AD Technical Writer will   be responsible for   consistently generating   high quality   technical documents, such as test procedures, protocols, and reports based on data collected by other members of the Analytical Development department that meet the needs of other departments, clients, and regulators .    Compliance with SOPs, cGMP, ICH, and other regulatory guidelines is   required   to perform most job tasks.   Responsibilities Drafting and revising controlled documents such as test procedures, method evaluation protocols, reports, and SOPs while following established guidelines for correctness, completeness, clarity, and format.   Coordinate the approvals of these documents   through the use of   software such as   MasterControl   and   TrackWise .   Compile and present data from multiple sources such as laboratory notebooks and various laboratory instrumentation software.   Maintain open communication with...