Product Quality Director - Synthetics

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Amgen

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Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• Join Amgen’s mission of serving patients and pioneer the world of biotech. • In this role, you will lead product quality and technical expertise in the Product Quality organization. • Responsibilities include driving operationally efficient processes and corporate alignment across international sites. • You will provide scientific oversight for product quality and be responsible for leadership of the Product Quality Team.

Requirements

• Doctorate Degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Master's Degree & 7 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor's Degree & 9 years of Quality, Operations, Scientific, or Manufacturing experience. • Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field. • 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience. • 6+ years working in a regulated environment (direct GMP). • 4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. • 2+ years experience as a technical expert or product champion. • 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation. • 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances. • Experience in Project Management in support of product development. • Knowledge of protein and small molecule quality, compliance and regulatory requirements. • Knowledge of analytical techniques used for small molecule and protein molecule product quality control. • Understanding of drug substance and drug product development and manufacturing. • Strong leadership and management skills. • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals. • Previous experience working on a cross-functional team in a matrix environment. • Excellent written and verbal communication skills, including facilitation and presentation skills.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions. • Group medical, dental and vision coverage. • Life and disability insurance. • Flexible spending accounts. • A discretionary annual bonus program. • Stock-based long-term incentives. • Award-winning time-off plans. • Flexible work models, including remote and hybrid work arrangements.