2026-1805 - Scientist, QC/Analytical Services H/F

Tue, 21 Apr 2026 11:53:23 Z

Job Family / Sub-family : R&D/Analytical Devpt
Contract type : Permanent
Position description :
· Work under the direction of the QC/analytical method development manager to develop/adopt preliminary analytical methods and optimize and validate those methods to support phase appropriate Good Manufacturing Practice (GMP) production in the Devens GMP suite. · Develop in-depth knowledge of analytical technologies applied in the pharmaceutical industry, and gain good understanding of regulatory guidelines applied to API manufacture and characterizations. · Participate in project meetings and present analytical results on active projects to both internal and external stakeholders and customers. · Work with colleagues to promote safe lab practices and adhere to Environment, Health and Safety (EHS) guidelines. · Take immediate action to correct any unsafe practices observed and promote safe work practices. · Perform all assigned tests, instrument qualification/calibration and report any issues that may occur. · Perform all tasks in full compliance with cGMP, regulatory (e.g., ICH. FDA), EHS and SEQENS guidelines. · Perform hands-on training as recommended by the QC/Analytical management. · Follow the standards, policies, and procedures necessary to maintain current GMP compliance. · Utilizes process knowledge, technical expertise and experience to assist in troubleshooting and correcting analytical equipment and technical issues. · Expected to help cover overtime and/or gaps in regular schedule to keep lab operating efficiently. · Maintain, procure and install a variety of analytical instrumentation. · Perform other related duties as directed or as responsibilities dictate. · Maintain work area and equipment in clean, safe, and orderly condition. · Participate in laboratory investigations for deviations, Out of Specification (OOS), Out of Trend (OOT) and material non-conformance. · Attend department meetings and ensure the department is proactively ready for all daily/ weekly activities (e.g., supplies, reagents, standards, materials; and accurate results delivered in a timely manner). Each employee contributes, by exercising his/her functions, to the efforts and commitments of the group in terms of Quality, Health, Safety and Environment. The manager/employee will develop, apply and make apply in his/her team: ü The Safety policy, the Safety procedures and the Safety behavior in general, ü The Environmental policy, the Environmental procedures and the Environmental behavior in general, ü The Quality policy, the Quality procedures and the Quality behavior in general.

· PhD degree in Chemistry or a related field * Minimum 5 years laboratory experience. · Good knowledge of general analytical chemistry and chromatography in the characterization of small molecule and polymer APIs. · Working knowledge of ICH guidelines and other regulatory guidances (e.g., FDA, EMA). · Ability to solve analytical problems and propose innovative solutions independently. · The candidate should have experience in current Good Manufacturing Practices (cGMP) in analytical method development/validation, Quality Control setting. · Desirable to have working knowledge performing and writing laboratory investigations, quality investigations, corrective and preventive actions (CAPA), and peer review. Prior experience interacting with Quality Assurance (QA) is essential.

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2026-1805 - Scientist, QC/Analytical Services H/F