Description du poste
Famille / Sous-famille d'emploi
R&D - Analytical Devpt
Type de contrat
Contrat à durée indéterminée
Intitulé du poste
Scientist, QC/Analytical Services H/F
Contexte du poste :
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.
Principales missions :
• 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.
Les atouts pour réussir :
• 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.
Localisation du poste
Localisation du poste
Etats Unis, Massachusetts, Devens
