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Associate Director, Drug Substance (Technical Operations) (Cambridge, MA)
Client is seeking an Associate Director of Drug Substance (Late-stage) to play operational and strategic leadership to the Drug Substance programs (starting materials and intermediates) within Technical Operations to support the development and optimization of Client’s clinical and commercial programs. The candidate will report to the Head of Technical Development and will coordinate process development, scale-up, analytical, and technology transfer to manufacturing sites, including managing operations and coordinating with Contract Manufacturing Organizations. Their responsibilities are critical to ensuring the consistent delivery of high-quality drug substances for clinical and commercial use, adhering to stringent regulatory standards.
Summary of Key Responsibilities:
· Identification of phase appropriate chemical process synthetic routes, ongoing clinical and commercial manufacturing processes development, identification of critical process parameters, process scale-up and technical transfers, validation, ongoing commercial support, and the oversight of contract drug substance manufacturing site.
· Support internal and external deviations/investigations, change controls, and authoring/review/approval of protocols, reports and relevant sections of clinical and commercial regulatory submissions (IND/IMPD, NDA/MAA) as well as the completion of commercial Annual Product Quality Reviews.
· Execute against phase appropriate development activities including PPQs and NDA writing
· Communicate overall strategy and project updates to senior leaders, external advisors, and collaborators.
· Manage and oversee activities at contract organizations worldwide to ensure compliant and robust manufacturing processes are both developed and/or maintained.
· Responsible and accountable for the timely production of clinical and commercial inventory (drug substance, starting material and intermediate) to support Client’s clinical programs and supply for established commercial programs.
· Support regulatory submissions by writing/ reviewing/approving drug substance related sections.
· Ability to wear multiple functional hats so that input into various complementary parts of the project can be managed in a rapid and localized manner.
· Ensure that CMC activities remain within projected timelines and budget.
· Identify, review and select the best external CROs, CDMOs and key consultants that are needed to allow smooth, efficient and cost-effective CMC support for programs advancing to the clinic.
Qualifications:
· PhD in Chemistry, Glyco-chemistry, Pharmaceutical sciences, Chemical Engineering or related field with 7+ years of experience in the pharmaceutical or biotech industry.
· Proven track record in Active Pharmaceutical Ingredient process development, including scale-up and technology transfer, coupled with a deep understanding of synthetic organic chemistry. Proficient in chemical synthesis, chromatography, and principles of process optimization and scale-up.
· Experience in polymer chemistry is preferred.
· Experience with upstream and downstream process will be a plus.
· Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
· Experience in working with CMOs and managing external partnerships.
· Excellent communication, organizational, and project management skills.
· Ability to think strategically and solve problems effectively.
· Commitment to fostering a collaborative and inclusive work environment.
Summary of Key Responsibilities:
· Identification of phase appropriate chemical process synthetic routes, ongoing clinical and commercial manufacturing processes development, identification of critical process parameters, process scale-up and technical transfers, validation, ongoing commercial support, and the oversight of contract drug substance manufacturing site.
· Support internal and external deviations/investigations, change controls, and authoring/review/approval of protocols, reports and relevant sections of clinical and commercial regulatory submissions (IND/IMPD, NDA/MAA) as well as the completion of commercial Annual Product Quality Reviews.
· Execute against phase appropriate development activities including PPQs and NDA writing
· Communicate overall strategy and project updates to senior leaders, external advisors, and collaborators.
· Manage and oversee activities at contract organizations worldwide to ensure compliant and robust manufacturing processes are both developed and/or maintained.
· Responsible and accountable for the timely production of clinical and commercial inventory (drug substance, starting material and intermediate) to support Client’s clinical programs and supply for established commercial programs.
· Support regulatory submissions by writing/ reviewing/approving drug substance related sections.
· Ability to wear multiple functional hats so that input into various complementary parts of the project can be managed in a rapid and localized manner.
· Ensure that CMC activities remain within projected timelines and budget.
· Identify, review and select the best external CROs, CDMOs and key consultants that are needed to allow smooth, efficient and cost-effective CMC support for programs advancing to the clinic.
Qualifications:
· PhD in Chemistry, Glyco-chemistry, Pharmaceutical sciences, Chemical Engineering or related field with 7+ years of experience in the pharmaceutical or biotech industry.
· Proven track record in Active Pharmaceutical Ingredient process development, including scale-up and technology transfer, coupled with a deep understanding of synthetic organic chemistry. Proficient in chemical synthesis, chromatography, and principles of process optimization and scale-up.
· Experience in polymer chemistry is preferred.
· Experience with upstream and downstream process will be a plus.
· Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
· Experience in working with CMOs and managing external partnerships.
· Excellent communication, organizational, and project management skills.
· Ability to think strategically and solve problems effectively.
· Commitment to fostering a collaborative and inclusive work environment.
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