CMC & Manufacturing, Science and Technology Drug Substance Lead
About The Position
Location Requirement: This position may be based on either the U.S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA) . The role requires periodic travel between both locations to support cross‑site collaboration and business needs. The CMC & Manufacturing, Science and Technology Drug Substance Lead will be responsible for: Experienced subject matter expert (SME) and process owner for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms. Lead the technical workstreams of a manufacturing process transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase. Experience in collaborating effectively with external manufacturing partners and to oversee all technical drug substance synthesis aspects (GMP and non-GMP steps). Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs Review and supervise design, set up, execution and documentation of DS related technical studies (CMC development as well as commercial operations), process and equipment qualifications and validations. Write and review applicable sections in registration files, variations and market expansion Issue, review and approve applicable internal and external SOP's and fully oversee correctness and compliance of external manufacturer manufacturing instructions. Contribute during set up of new analytical specifications and stability programs and review changes thereof Support in sourcing evaluation of new Drug Substance small molecules, oral dosage forms alternative contract manufacturers and participation in developing supply and quality agreements. Be aware of modern synthetic organic chemistry methodologies, advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
Requirements
- University education in Chemistry, Pharmacy or similar.
- 10+ years of experience of development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use. Ideally for more than 2 molecules.
- Recognized expert in in synthetic organic chemistry and process R&D; experience with deuterated molecules is a plus.
- Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug substance.
- Experience of working with external manufacturers
- Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker
- Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
- Fluent in English, intermediate to full proficiency in Chinese is a plus.
- Strong cross-functional team player with a strong track record to achieve compromise
- Ability to act independently and show strong ownership
- High agility to deliver in a changing environment and be able to build strong scenarios approaches
- Excellent communication skills, oral/written and listening to external and internal partners and stakeholders.
Nice To Haves
- Recognized expert in in synthetic organic chemistry and process R&D; experience with deuterated molecules is a plus.
- Fluent in English, intermediate to full proficiency in Chinese is a plus.
Responsibilities
- Experienced subject matter expert (SME) and process owner for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms.
- Lead the technical workstreams of a manufacturing process transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase.
- Experience in collaborating effectively with external manufacturing partners and to oversee all technical drug substance synthesis aspects (GMP and non-GMP steps).
- Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs
- Review and supervise design, set up, execution and documentation of DS related technical studies (CMC development as well as commercial operations), process and equipment qualifications and validations.
- Write and review applicable sections in registration files, variations and market expansion
- Issue, review and approve applicable internal and external SOP's and fully oversee correctness and compliance of external manufacturer manufacturing instructions.
- Contribute during set up of new analytical specifications and stability programs and review changes thereof
- Support in sourcing evaluation of new Drug Substance small molecules, oral dosage forms alternative contract manufacturers and participation in developing supply and quality agreements.
- Be aware of modern synthetic organic chemistry methodologies, advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
