Associate Director, Drug Substance
Skills
- Expertise in oligonucleotide and synthetic peptide process development and scale-up
- Strong knowledge of cGMP, ICH guidance, and FDA CMC expectations
- Experience managing CDMO relationships and technology transfers
- Ability to author regulatory Module 3 and validation documentation
- Data-driven problem solving, risk assessment, and decision making
- Clear cross-functional communication and stakeholder influence
Responsibilities
- Lead drug substance process development from early clinical phases through NDA, ensuring Module 3 supports global filings and registrations
- Serve as technical SME and process owner for oligonucleotide and peptide drug substance manufacturing
- Develop scalable, robust manufacturing processes and impurity control strategies with contract manufacturing organizations
- Evaluate and qualify CDMOs for toxicology and clinical material supply and lead tech transfers
- Monitor GMP operations, review clinical batch records, trend process data, and support quality events
- Author Module 3 content for IND/NDA, Master Batch Records, and validation plans/reports
- Assess regulatory impact of proposed changes and mitigate supply risk
- Track critical path activities, anticipate risks, and develop contingency and decision plans
- Collaborate regularly with Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing
- Travel to global manufacturing sites to support operations and validation (up to ~10%)
Education
- Bachelor’s degree in organic chemistry, chemical engineering, or related field (required)
- Master’s degree in a relevant field preferred
Benefits
- Remote work opportunities within the United States with periodic travel to Cambridge, MA
- Inclusion in company-wide professional development and collaboration with cross-functional CMC teams
- Equal Opportunity Employer with reasonable accommodations during the selection process
- Opportunity to contribute to late-stage clinical and registration activities for high-impact therapies
Average salary estimate
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Lead small-molecule drug substance process development and CDMO management for a publicly traded biotech advancing registration-directed clinical programs.
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