Senior Director, Manufacturing Sciences & Technologies
ADC Therapeutics
18 days ago
Remote
United States
Operations
What You’ll Do:
The Senior Director of Manufacturing Sciences & Technologies (MSAT) is a senior technical leader responsible for end-to-end process ownership, technical oversight, and lifecycle management of drug substance intermediates, ADC drug substance, and ADC drug product manufactured through a global network of external CDMOs. Ensures robust, scalable, and compliant manufacturing processes supporting commercial manufacturing, process development, and clinical development; provides senior technical support to internal Production Management Teams and external manufacturing partners. Critical role in process validation, technology transfer, continued process verification (CPV), change management, and technical/regulatory support across antibody, linker-payload, conjugation, formulation, fill-finish, and packaging.
Job Responsibilities:
- Lead and develop MSAT function for ADC end-to-end manufacturing across clinical and commercial stages.
- Define external manufacturing MSAT strategy aligned with corporate objectives.
- Develop and mentor the MSAT team.
- Oversee process development, scale-up, and tech transfer at/to CDMOs; PPQ; ongoing monitoring and CPV.
- Drive issue resolution for deviations, CAPAs, and change requests.
- Support CDMO selection, technical due diligence, and onboarding.
- Provide oversight across the full ADC manufacturing lifecycle; implement post-approval changes and process optimization.
- Accountable for regulatory submissions/inspections (INDs, BLAs, MAAs, supplements); author/review CMC regulatory sections and responses; support health authority inspections.
- Partner with Quality for cGMP/ICH/global compliance; provide scientific justifications for control strategies, specifications, and lifecycle changes.
- Establish/track CPPs and CPV metrics; identify/mitigate risks across external manufacturing network; drive lessons learned/standardization/continuous improvement.
Requirements:
- MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, or related field (BS with significant experience considered).
- 10+ years relevant experience in biologics manufacturing, bioconjugation, CMC operations, and CDMO management.
- Strong problem-solving, root-cause analysis, and executive/regulatory/partner communication skills.
- Deep bioconjugation technology knowledge; extensive GMP operations, process validation, CPV, and regulatory submission prep experience.
- Proven ability to build/lead technical and cross-functional teams; ability to lead through influence (including remote/external).
- Travel ~10–20% (primarily to CDMOs).
Application instructions: Not provided.
The Senior Director of Manufacturing Sciences & Technologies (MSAT) is a senior technical leader responsible for end-to-end process ownership, technical oversight, and lifecycle management of drug substance intermediates, ADC drug substance, and ADC drug product manufactured through a global network of external CDMOs. Ensures robust, scalable, and compliant manufacturing processes supporting commercial manufacturing, process development, and clinical development; provides senior technical support to internal Production Management Teams and external manufacturing partners. Critical role in process validation, technology transfer, continued process verification (CPV), change management, and technical/regulatory support across antibody, linker-payload, conjugation, formulation, fill-finish, and packaging.
Job Responsibilities:
- Lead and develop MSAT function for ADC end-to-end manufacturing across clinical and commercial stages.
- Define external manufacturing MSAT strategy aligned with corporate objectives.
- Develop and mentor the MSAT team.
- Oversee process development, scale-up, and tech transfer at/to CDMOs; PPQ; ongoing monitoring and CPV.
- Drive issue resolution for deviations, CAPAs, and change requests.
- Support CDMO selection, technical due diligence, and onboarding.
- Provide oversight across the full ADC manufacturing lifecycle; implement post-approval changes and process optimization.
- Accountable for regulatory submissions/inspections (INDs, BLAs, MAAs, supplements); author/review CMC regulatory sections and responses; support health authority inspections.
- Partner with Quality for cGMP/ICH/global compliance; provide scientific justifications for control strategies, specifications, and lifecycle changes.
- Establish/track CPPs and CPV metrics; identify/mitigate risks across external manufacturing network; drive lessons learned/standardization/continuous improvement.
Requirements:
- MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, or related field (BS with significant experience considered).
- 10+ years relevant experience in biologics manufacturing, bioconjugation, CMC operations, and CDMO management.
- Strong problem-solving, root-cause analysis, and executive/regulatory/partner communication skills.
- Deep bioconjugation technology knowledge; extensive GMP operations, process validation, CPV, and regulatory submission prep experience.
- Proven ability to build/lead technical and cross-functional teams; ability to lead through influence (including remote/external).
- Travel ~10–20% (primarily to CDMOs).
Application instructions: Not provided.