Sr. Manager, Drug Product Manufacturing (San Diego)QualStaff Resources • San Diego, CA, US

Sr. Manager, Drug Product Manufacturing (San Diego)

QualStaff Resources • San Diego, CA, US

1 day ago

Job type

Part-time

Permanent

Job description

Sr. Manager, Drug Product Manufacturing

QUICK 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.

7+ years hands-on and leadership experience (internal / external partner) in process development for biologic molecules, preferably monoclonal antibodies with combination products including prefilled syringes, needle guard safety systems and autoinjectors.

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 stagessupporting 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.

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Sr Product Manager • San Diego, CA, US

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