Principal Product Quality Leader (Synthetics)
Amgen Inc
Amgen seeks a Principal Product Quality Leader to provide technical expertise and product leadership for synthetic pharmaceutical programs. The role involves cross-functional collaboration on quality strategy, regulatory submissions, manufacturing controls, and product lifecycle management.
Responsibilities
- Lead quality strategy development for late-phase and commercial synthetic programs across Product Quality Teams
- Author, review, and maintain GMP and regulatory documentation; execute transactions in quality systems and databases
- Conduct science and risk-based evaluation of complex process and product quality data to support decision-making
- Communicate complex technical information to leadership, peers, and regulatory agencies in oral and written formats
- Support product quality initiatives including annual reviews, comparability assessments, and stability programs
Requirements
- Doctorate degree with 2+ years quality/operations/manufacturing experience, or equivalent education/experience combination
- Bachelor's degree in chemistry, biochemistry, biology, or related pharmaceutical sciences preferred
- 6+ years in regulated environment with direct GMP or technical support experience
- 1+ year authoring or reviewing regulatory documentation (IND, market applications, supplements)
- 1+ year supporting non-conformance investigations and critical product impact assessments
- Knowledge of cGMP, US and international pharmaceutical filing regulations and practices
- Experience with synthetic pharmaceutical bulk and drug product development and analytical techniques
Vacancy posted 16 days ago
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