Quality - Stability Scientist

Principal Scientist Location: Devens, MA Work Schedule: Mon - Fri, Business Hours Description - External Global Biologic Stability (GBS) oversees stability programs for all commercial biologics Drug Substance and Drug Products across manufacturing sites. The Stability Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for stability product strategy, including annual enrollments, process change assessments, and investigations. The Scientist may represent the stability function on Technical Product Teams and assist with stability study generation, sample management, data evaluation/trending, and reporting, in accordance with cGMPs and SOPs.

MAJOR DUTIES AND RESPONSIBILITIES:

Collaborate with Technical Product Teams, Regulatory Sciences, and manufacturing sites to develop stability requirements for enrollments, process changes, and investigations. Perform and document impact assessments of change controls; initiate change controls for stability operations as needed. Represent GBS in investigations, perform stability impact assessments. Support the generation, revision, review, and approval of master stability protocols and study-specific protocols. Assist with stability data reporting, including supporting health authority submissions and responses. Develop and revise SOPs/WIs; assist in creating stability directives. Identify, escalate, and act on stability program issues impacting lab capacity, studies, or regulatory commitments. Identify training needs and ensure ongoing training for stability activities. Work in compliance with cGMP requirements and regulatory expectations. Qualifications - External Knowledge and Skills: Minimum of 2 years (PhD), 6-8 years (MS), or 8-10 years (BS) of relevant cGMP experience in biopharma. Knowledge of ICH Guidelines (Q1A, Q5C) and cGMP regulations, especially as they relate to biologics stability programs. Excellent communication skills for technical discussions, change control, and investigations. Experience with evaluating stability data using statistics software. Understanding of analytical/microbiology testing, pharmaceutical manufacturing, and quality practices. Strong leadership, decision-making, and problem-solving skills. Experience in operational excellence and continuous improvement. Prior experience with stability troubleshooting, especially in small molecules. Ability to work independently, analyze data, and prioritize multiple projects. Knowledge of US/EU/ROW requirements and industry best practices; proficiency with MS Office, SAP, LIMS, Trackwise, JMP. Decision Making: Works on diverse problems, evaluates situations, exercises judgment within policies, and advises subordinates. Develops performance standards and recommends policy changes. Supervision: Receives objectives and establishes goals. Work is reviewed based on objectives and schedules. Reports discrepancies and recommends corrective actions. May supervise exempt/non-exempt employees. #J-18808-Ljbffr TechDigital Group