Sr. Manager, Drug Product Manufacturing

Sr. Manager, Drug Product Manufacturing

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FACTS

• Location : San Diego, CA 92130
• Duration : Permanent
• Pay Range : $160,000 - $180,000

EXPERIENCE NEEDED

Bachelor of Science degree in Bioengineering, Biology, Cell Biology, Chemical Engineering Biochemistry, or other relevant scientific discipline or equivalent experience; advanced degree preferred.

Proven background leading process development for complex biologic products, ideally with experience in combination delivery systems such as prefilled syringes or autoinjectors.

Solid understanding of formulation, device integration, and analytical methods used to characterize biologic drug products.

Extensive experience supporting late-stage development, process scale-up, and regulatory submissions for biologic therapies.

MAIN DUTIES OF THE JOB

Lead ongoing drug substance activities at CMOs, including GMP manufacturing, PPQ work, stability studies, and other phase-appropriate production campaigns.

Oversee development and manufacturing of drug product at CDMOs, with a focus on sterile injectable presentations such as 1 mL and 2.25 mL PFS formats.

Provide scientific and operational leadership across development stages—supporting tech transfer, scale-up, process optimization, and commercialization readiness.

Manage all activities related to technology transfer and CMC execution at external partners, ensuring successful assembly, testing, and release of final drug product.

The company is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws.