Associate Director, Drug Product
Disc Medicine
19 days ago
Remote friendly (Watertown, MA)
United States
Operations
Responsibilities:
- Provide leadership for drug product technical elements across biologic drug product programs (antibodies/proteins).
- Lead selected clinical and/or commercial formulation studies.
- Lead drug product process development and characterization for selected unit operations up to and including PPQ (process performance qualification) batches.
- Participate in selecting/recommending external providers (CMOs/CROs) as needed.
- Lead technical drug product process transfers to CMOs and oversee formulation, process development, and manufacturing at CDMOs.
- Provide expertise in biologics development areas including in-use compatibility, extractables/leachables, and filter validation.
- Contribute to subcutaneous delivery device selection and, as needed, design control/validation (e.g., pre-filled syringes, needle safety devices, autoinjectors).
- Collaborate with CMC functions (drug substance, analytical, QC, supply chain, quality/regulatory).
- Contribute to budget management for assigned programs.
- Identify/communicate technical risks and recommend mitigation plans.
Requirements:
- BS/MS in Chemical Engineering, Pharmaceutical Sciences, or similar.
- 10–15 years in pharmaceutical/biopharmaceutical industry; minimum 4–6 years hands-on early/late-stage drug product development (formulation, process, device, technology transfer).
- Knowledge of sterile drug product development, technology transfer, and manufacturing.
- Antibody formulation experience across lifecycle (FIH through commercial).
- Experience contributing to drug product sections of early/late-stage and commercial filings (highly preferred).
- Strong cross-functional communication (Drug Substance, Analytical, Quality, Regulatory, Program Mgmt).
- Significant CMC team experience with CMC leaders.
- Experience with domestic/international CDMOs for development/GMP manufacturing (including person-in-plant support).
- Ability to contribute to high-performing cross-functional teams.
- Travel 20–30% may be required.
Application instructions:
- Submit a cover letter and resume to be considered for current and future opportunities.
- Provide leadership for drug product technical elements across biologic drug product programs (antibodies/proteins).
- Lead selected clinical and/or commercial formulation studies.
- Lead drug product process development and characterization for selected unit operations up to and including PPQ (process performance qualification) batches.
- Participate in selecting/recommending external providers (CMOs/CROs) as needed.
- Lead technical drug product process transfers to CMOs and oversee formulation, process development, and manufacturing at CDMOs.
- Provide expertise in biologics development areas including in-use compatibility, extractables/leachables, and filter validation.
- Contribute to subcutaneous delivery device selection and, as needed, design control/validation (e.g., pre-filled syringes, needle safety devices, autoinjectors).
- Collaborate with CMC functions (drug substance, analytical, QC, supply chain, quality/regulatory).
- Contribute to budget management for assigned programs.
- Identify/communicate technical risks and recommend mitigation plans.
Requirements:
- BS/MS in Chemical Engineering, Pharmaceutical Sciences, or similar.
- 10–15 years in pharmaceutical/biopharmaceutical industry; minimum 4–6 years hands-on early/late-stage drug product development (formulation, process, device, technology transfer).
- Knowledge of sterile drug product development, technology transfer, and manufacturing.
- Antibody formulation experience across lifecycle (FIH through commercial).
- Experience contributing to drug product sections of early/late-stage and commercial filings (highly preferred).
- Strong cross-functional communication (Drug Substance, Analytical, Quality, Regulatory, Program Mgmt).
- Significant CMC team experience with CMC leaders.
- Experience with domestic/international CDMOs for development/GMP manufacturing (including person-in-plant support).
- Ability to contribute to high-performing cross-functional teams.
- Travel 20–30% may be required.
Application instructions:
- Submit a cover letter and resume to be considered for current and future opportunities.