Associate Director, Technical Operations Small Molecule CMC

Planet Pharma; San Diego (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Planet Pharma is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at CDMOs, supporting late-stage development through commercialization.

The role partners with QA, Regulatory, Clinical, and Supply Chain to manage risk, milestones, and regulatory filings, requiring 8+ years in small molecule CMC and strong experience with GMP, INDs, and NDAs.

Qualifications

• 8+ years in late-stage clinical development, scale-up, and commercialization.
• Experience managing and overseeing CDMOs and external testing labs.
• Broad knowledge of phase-appropriate cGMP US/EU/ICH guidelines.
• Ability to prepare/review CMC sections in regulatory filings.
• Strong collaboration with QA, Regulatory, Clinical, and Supply Chain.

Responsibilities

• Provide technical oversight of API production, scale-up, PPQ for small molecule APIs.
• Review manufacturing-related documentation: change controls, batch records, tech transfer, validation reports.
• Verify qualification and validation status of CDMO processes.
• Support GMP quality systems: deviations, investigations, CAPAs, change controls, submissions, inspections.
• Collaborate with internal/external teams for CMC development and lifecycle management.
• Author/review INDs, IMPDs, and NDAs.
• Maintain up-to-date US/EU GMP and ICH regulatory knowledge.
• Ensure CDMO activities meet scope, timelines, and quality.
• Additional duties as needed.

Skills

API development

Process development

Scale-up

PPQ

CDMO oversight

CMC regulatory documentation

Education

B.S. in life sciences

MS/PhD preferred

Job description

Planet Pharma is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at CDMOs, supporting late-stage development through commercialization.

The role partners with QA, Regulatory, Clinical, and Supply Chain to manage risk, milestones, and regulatory filings, requiring 8+ years in small molecule CMC and strong experience with GMP, INDs, and NDAs.