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Product Quality Director, Hybrid Modalities
Lead product quality strategy for Amgen’s hybrid-modality medicines, overseeing GMP activities, stability programs, regulatory submissions, and cross-functional teams.
संयुक्त राज्य
कैलिफ़ोर्निया
मैसाचुसेट्स$1,76,370 – $2,38,619 / वर्ष
हाइब्रिडपूर्णकालिकलीडआवश्यक भाषा: अंग्रेज़ीनिदेशकविवरण
- Act as Product Quality Leader and advocate for a product team.
- Set technical direction and lead strategy and projects across Product Quality.
- Partner with quality, regulatory, development, manufacturing, and executive teams across the organization.
- Address product quality matters across manufacturing, testing, specifications, stability, investigations, change control, submissions, and inspections.
- Improve operational processes and align quality practices across international sites.
- Support development and commercial lifecycle management for large and small molecules.
- Lead Product Development Team quality work, including comparability, specifications, stability, and annual product reviews.
- Provide scientific oversight for pivotal and commercial products.
- Review product data, maintain GMP documents and filing sections, use GMP systems, and support audits and regulatory responses.
- Lead the Product Quality Team, oversee stability programs, and guide staff indirectly.
- Manage long-term hybrid-modality program deliverables, including specifications, comparability, stability, transfers, non-conformance impact statements, filing sections, and responses to questions.
- Assess complex processes and product data using scientific and risk-based methods.
- Explain complex topics to leaders, colleagues, and regulators.
- Track emerging scientific and technical developments and their implications.
- Coach new and current team members.
आवश्यकताएँ
- Doctorate plus 4 years of quality, operations, scientific, or manufacturing experience; master’s plus 7 years; or bachelor’s plus 9 years.
- Advanced degree in chemistry, biochemistry, biology, or a related biotechnology science.
- Expertise in large- and small-molecule and bioconjugate development, analytical testing, and industry regulations.
- At least 8 years of pharmaceutical experience with increasing responsibility in quality, analytical or process development, pharmaceutics, regulatory, or manufacturing.
- At least 6 years working directly in a GMP-regulated environment.
- At least 4 years managing people or leading teams, projects, or programs, or directing resource allocation.
- At least 2 years as a technical expert or product champion.
- At least 1 year authoring or reviewing regulatory filings or similar documentation.
- At least 1 year supporting non-conformance investigations and authoring, reviewing, and defending critical product-impacting non-conformances.
- Project management experience supporting product development.
- Knowledge of quality, compliance, and regulatory requirements for proteins and small molecules.
- Knowledge of analytical methods used in small-molecule and protein product quality control.
- Understanding of drug substance and drug product development and manufacturing.
- Strong leadership and people management skills.
- General knowledge of cGMP and filing regulations, practices, and trends for pharmaceutical manufacture and testing.
- Experience working on cross-functional teams in a matrix environment.
- Excellent written and verbal communication, facilitation, and presentation skills.
लाभ
- Comprehensive employee benefits package.
- Retirement and savings plan with company contributions.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work arrangements, including remote and hybrid options where available.
- Career development opportunities.
- Support for work-life balance.
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