Associate Director, Biologics Operations & Downstream Process

Planet Pharma; San Diego (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Planet Pharma seeks an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing in San Diego to provide technical leadership for late-stage and commercial biologics CDMO manufacturing, focusing on downstream production.

The role requires deep expertise in microbial fermentation, PPQ, and CMC documentation for IND/BLA submissions, with experience managing QbD and lifecycle processes, as well as collaboration across QA, Regulatory, and Ops teams. Travel 20-25% is expected.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field.
• Advanced degree (M.S./Ph.D.) preferred in related disciplines.
• 8+ years of biologics manufacturing, scale-up, late-stage development and commercialization.

Responsibilities

• Provide technical oversight for drug substance manufacturing at CDMOs, with focus on downstream production.
• Review manufacturing documents including batch records, tech transfer, PPQ protocols and reports.
• Serve as technical resource for GMP quality systems, deviations, CAPAs, change controls and regulatory responses.
• Monitor process performance data, identify trends, and propose improvements for robustness and efficiency.
• Support tech transfer and process scale-up at CDMOs.
• Collaborate with Regulatory Affairs to prepare CMC documentation for IND, BLA and responses.
• Author technical reports and support lifecycle management, including post-approval changes and CPV.

Skills

Biologics manufacturing

Microbial fermentation

Downstream processing

Process Validation

QbD

Technical writing

Regulatory submissions

Lifecycle management

Education

Bachelor's degree in Life Sciences or related

Advanced degree (M.S./Ph.D.) preferred

Job description

Planet Pharma seeks an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing in San Diego to provide technical leadership for late-stage and commercial biologics CDMO manufacturing, focusing on downstream production.

The role requires deep expertise in microbial fermentation, PPQ, and CMC documentation for IND/BLA submissions, with experience managing QbD and lifecycle processes, as well as collaboration across QA, Regulatory, and Ops teams. Travel 20-25% is expected.