Associate Director, Drug Substance Development & Manufacturing
New
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Entrada TherapeuticsBiopharmaceutical
This is a US based remote position with preference given to local New England based candidates.Full-TimeManager
Salary172,000 - 202,000 USD per year
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Job Details
- Experience
- 8+ years
- Required Skills
- Project ManagementQuality Assurance
Requirements
- Master’s or suitable advanced degree in organic chemistry or other scientific or engineering discipline.
- 8+ years of related experience in the pharmaceutical industry.
- Demonstrated proficiency in process development, tech transfer, scale-up, and GMP manufacturing for clinical and commercial supplies.
- Proficiency in managing activities and resolving manufacturing challenges at CDMOs.
- Experience in onboarding, managing, and collaborating with CDMOs, raw material suppliers, and testing partners.
- Strong project management, interpersonal, communication, and problem-solving skills.
- Up-to-date knowledge of industry practices and regulations (e.g., GxP, ISO, ICH) across FDA and EMA.
- Ability to travel up to 20% (domestic and international).
- Ability to travel to Boston, MA headquarters at least monthly or quarterly.
Responsibilities
- Facilitate timely execution, disposition, and release of intermediate/drug substance batches through detailed technical review of cGMP documentation.
- Partner with internal and external quality and technical operations teams to execute late-stage development activities including Process Characterization and Process Performance Qualifications.
- Act as a person-in-plant for manufacturing activities for clinical and commercial batches.
- Conduct risk assessments and develop mitigation strategies for manufacturing-related issues.
- Implement and manage the Continuous Process Verification (CPV) program.
- Author/review change controls to introduce process improvements from Phase 1 through commercialization.
- Partner with internal teams for CDMO due diligence and selection.
- Author/review related sections in regulatory filing documents such as IND, IMPD, NDA, BLA, and MAA.
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