Sr Associate, Outsourced Manufacturing

Scorpion Therapeutics; United States; On-site; USD 118,000 - 153,000; Full time

Benefits offered by this job

Discretionary bonus

Long-term incentives

Paid time off

Medical/dental/vision/life insurance

Job summary

Senior Associate, Global External Manufacturing (based at Gilead Foster City campus) joins Scorpion Therapeutics to manage external manufacturing partnerships, oversee CMOs, and drive transfer and validation of manufacturing processes across the product lifecycle.

You will optimize cost, quality, and supply continuity, ensure cGMP compliance, coordinate with Technical Development and internal sites, and travel up to 20% as needed to support global regulatory requirements and project milestones.

Qualifications

• BA/BS in science or engineering with 5+ years pharma/biotech experience, or MS/MBA with 2 years relevant experience.
• Experience in drug product manufacturing and supply chain execution/oversight.
• Understanding of cGMP and regulatory expectations.

Responsibilities

• Execute Global External Manufacturing network strategy.
• Tactical execution with external manufacturers; manage supplier performance.
• Coordinate transfers and validation with internal sites for tech transfer.
• Manage CMOs to ensure manufacturing per registered process and Master Production Record.
• Resolve deviations, investigations, MRB, trending, and change control.
• Drive continuous improvement to reduce cost and improve quality.
• Represent manufacturing on cross-functional teams across product lifecycle.

Skills

pharma/biotech experience

drug product manufacturing

supply chain oversight

cGMP knowledge

Education

BA/BS in science or engineering

MS/MBA substitution allowed

Job description

Senior Associate, Global External Manufacturing (based at Gilead Foster City campus)

Responsibilities:

• Execute Global External Manufacturing network strategy.
• Tactical execution with external manufacturing organizations; manage supplier performance.
• Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal sites for successful technology transfer/validation to identified CMOs.
• Manage CMOs to ensure products are manufactured per registered process and approved Master Production Record.
• Resolve manufacturing/compliance issues: deviations, out-of-spec investigations, Material Review Board investigations, finished product trending, and change control.
• Drive continuous improvement to reduce cost, improve quality/efficiency, and ensure sustainability.
• Represent manufacturing on cross-functional Development/Commercial CMC teams across product lifecycle (clinical to launch to routine supply to sunset/divestiture).

Basic Qualifications:

• BA/BS in science or engineering + 5+ years progressive pharma/biotech experience; or MS/MBA substituting 2 years relevant experience.
• Experience in drug product manufacturing and supply chain execution/oversight.
• Understanding/application of cGMP.

Preferred Qualifications:

• Knowledge of worldwide regulatory requirements, including ICH.
• CMO landscape knowledge (plus).
• International travel (overnight) up to 20%.
• Exceptional verbal/written communication with senior leaders and CMOs.

Compensation/Benefits (as stated):

• Salary range $117,895.00–$152,570.00; may be eligible for discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.