Director / Sr. Director, Manufacturing Sciences

About the role

Angitia is seeking a Director or Senior Director of Manufacturing Sciences to lead technical oversight of drug substance manufacturing across outsourced CDMOs. The role bridges Process Development, Analytical Development, and external partners to ensure programs are manufacturing‑ready for Phase 3, validation, and commercial supply.

Key responsibilities

• Act as the sponsor‑side technical point of contact for CDMO manufacturing activities, providing on‑site oversight during engineering runs, PPQ, and process changes.
• Review CDMO batch records, in‑process data, deviations, CAPAs, and change controls, delivering technical assessments.
• Establish and own a Continued Process Verification (CPV) program, trend process and analytical data, and identify improvement opportunities.
• Integrate CMC documentation from Process Development and Analytical Development into regulatory submissions (IND, CTA, IMPD) and ensure quality of CDMO‑generated content.
• Draft and finalize responses to health‑authority RFIs and CMC queries.

Required profile

• Extensive experience in late‑stage drug substance development and process validation.
• Proven track record overseeing CDMO execution and ensuring manufacturing readiness for Phase 3 and commercial supply.
• Comfortable working in a lean, fast‑growing organization and driving pragmatic, high‑impact decisions.
• Strong collaboration skills with Process Development, Analytical Development, Quality, Regulatory, and Program Management teams.

Required skills

• Drug substance manufacturing expertise
• CDMO technical oversight
• Process verification and monitoring
• Regulatory documentation preparation (IND, CTA, IMPD)
• Technical writing for CMC content

What we offer

• Remote work with up to 20% global and domestic travel
• Opportunity to shape CMC strategy in a fully outsourced biopharma model
• Collaborative US‑based CMC team environment