Principal Scientist QA

Position Brand Description

Early Phase Quality Assurance (GMP Quality) accountable for the PR&D Early Phase Team, providing day-to-day Quality oversight of Early Phase Teams and external partners to execute the early phase development portfolio.

• Support delivery of early phase pre-commercialization information/materials (typically through Phase II), ensuring quality expectations are met.
• Execute Early Phase Quality System to sustain compliance with regulatory requirements and GMP.
• Review and approve manufacturing documentation.
• Disposition API, in-process materials, dosage forms, and finished drug product for Clinical Trials (including review of GMP documentation, analytical results, and regulatory commitments).
• Coordinate deviation and complaint investigations; review/approve deviations, change documents, and specifications.
• Provide QA input to CM&C Development Plans.
• Qualify contract manufacturers/packagers, testing labs, vendors, and suppliers; oversee partner activities to optimize compliance and efficiency.
• Collaborate with internal partners (SMDD,  &D, PD, ELECTS) to ensure appropriate oversight of external Early Phase activities.
• Provide on-site support for manufacturing/packaging/labeling of investigational medicinal products (as needed).
• Participate in continuous improvement; ensure inspection readiness (self-assessments, GMP education, quality systems, support for internal/regulatory inspections).

• 5+ years professional experience; global clinical trial cGMP experience.
• Breadth of technical/quality knowledge (at least
  2): API, drug product manufacturing, clinical trial packaging, analytical labs, ADC.
• Large Molecule manufacturing and Antibody Drug Conjugation experience.
• Interpret/apply phase-appropriate GMP; proficiency with applicable computer systems.
• Strong communication; critical thinking/problem-solving (root cause analysis); attention to detail.
• Data handling/integrity experience; change management; deviation management/investigations.

• Independent/team issue resolution; prior QA/QC/Operations/TS/MS/Engineering/Regulatory experience.
• PR&D Quality Systems and/or CT Operations knowledge; cGMP auditing experience.

• Bachelor’s degree in a Science-related field or Engineering, or equivalent experience.

Travel US and OUS (including India and China) required (10–20%).

• Anticipated wage: $65,250–$169,400. Company bonus eligibility and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).