Associate Director, Drug Product Ops & CDMO Strategy

Planet Pharma; San Diego (CA); Remote; USD 150,000 - 195,000; Full time

Job summary

Planet Pharma seeks an Associate Director, Technical Operations – Drug Product to lead drug product manufacturing, scale up, and PPQ activities for a small molecule solid oral product. You will manage external CDMOs and collaborate with Quality, Regulatory CMC, Clinical, and Supply Chain teams.

The role requires 8+ years in small molecule manufacturing, strong PPQ and cGMP knowledge, and experience with IND/IMPD/NDAs. Advanced degree preferred.

Qualifications

• Experience with scale-up of solid oral drug products.
• Expertise in process development and characterization.
• Experience managing external CDMOs and testing labs.
• Strong knowledge of cGMP and regulatory expectations (IND/IMPD/NDAs).

Responsibilities

• Oversee drug product manufacturing at external CDMOs.
• Review batch records, change controls, and validation reports.
• Provide technical support for GMP deviations, CAPAs, and regulatory submissions.
• Lead collaboration with internal teams on CMC development and commercialization.
• Maintain up-to-date knowledge of US/EU GMPs and guidance.

Skills

Scale-up

Process development

PPQ

CDMO management

Education

Bachelor’s degree in Chemistry or related

MS/PhD preferred

Tools

Regulatory filings knowledge

Job description

Planet Pharma seeks an Associate Director, Technical Operations – Drug Product to lead drug product manufacturing, scale up, and PPQ activities for a small molecule solid oral product. You will manage external CDMOs and collaborate with Quality, Regulatory CMC, Clinical, and Supply Chain teams.

The role requires 8+ years in small molecule manufacturing, strong PPQ and cGMP knowledge, and experience with IND/IMPD/NDAs. Advanced degree preferred.