Under the direction of the Quality Control/Analytical Development Manager, the scientist performs method development, instrument qualification/calibration, method validation activities, and analytical testing to support manufacture of SEQENS products, and reports any issues that might appear. The position requires a person who is detail-oriented, responsible, can work independently, and has experience documenting quality issues and tracking their resolution.

·       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.