Manager / Sr. Manager, Chemical Development & Clinical ManufacturingLocation Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Chemistry Operations Group at BioMarin seeks an experienced scientist to manage external synthetic chemistry and manufacturing efforts in support of pre-clinical and clinical programs. These programs span a range of modalities (traditional small molecules, oligonucleotides, peptides, polymers, and conjugates) produced at contract manufacturing organizations (CMOs) operating under non-cGMP or cGMP requirements, as appropriate. Synthetic targets include active pharmaceutical ingredients as well as critical raw materials, reagents, reference standards, and intermediates. The position requires both business and scientific interactions with colleagues from a range of departments including (but not limited to) Analytical Chemistry, Formulation, Discovery Research, Supply Chain, and Quality Control. All activities managed by the Chemistry Operations group are remote; as such, no hands-on laboratory activities would be required.
- Assimilate technical details (synthetic and analytical) regarding early stage processes so as to draft effective Requests for Proposals (RFPs) to be submitted to potential CMOs.
- Manage interactions on technical and business levels with contract manufacturing sites, ensuring timely delivery and that product(s) meet mutually agreed-upon specifications.
- Oversee, troubleshoot, and optimize synthesis steps and analytical methods where needed. Proactively identify potential liabilities using sound technical knowledge. Engage with counterparts at CMOs and serve as BioMarin technical expert on assigned programs.
- Serve as Person-in-Plant as needed for manufacturing campaigns, providing real-time manufacturing oversight on both synthetic and analytical aspects of assigned programs.
- Draft technical reports as needed and review/approve certificates of analysis, methods, and reports provided by CMOs for technical accuracy, completeness, and compliance.
- Use ERP systems (SpringCM, Oracle) to process/track contracts and work in close collaboration with BioMarin Legal and Finance departments to ensure accurate accounting in accordance with BioMarin policies and procedures.
- Present findings internally at cross-functional meetings in a matrix organization, across multiple departments at multiple levels.
- Attend conferences and trainings (as schedule permits) to ensure up-to-date knowledge of industry best practices and maintain expertise.
- Availability for up to 20% business travel, as needed.
- PhD in chemistry with a minimum of 3 years’ industry experience. MS-level candidates will also be considered, depending on academic and industrial experience.
- Excellent hands-on understanding of organic chemistry on practical and mechanistic levels.
- Solid understanding of routine analytical methods (HPLC, NMR, MS).
- Ability to assimilate, filter, and assemble technical information from a variety of sources to glean an understanding of assigned projects.
- Clear, cohesive, and concise communication in verbal and written form.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.