Manager/Sr. Manager, Drug Substance Contract Manufacturing

Employer
BioMarin
Location
Novato, California
Salary
Depends on Experience
Posted
May 07, 2018
Closes
Jun 06, 2018
Field of specialization
Engineering
Work Function
Manufacturing
Job Type
Full time

Summary:

The Drug Substance Contract Manufacturing Group (DSCM) 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) and similar supplier laboratories, operating under non-cGMP or cGMP requirements, as appropriate. Synthetic targets include active pharmaceutical ingredients as well as critical raw materials, reagents, reference standards, metabolites 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 DSCM are external; as such, no hands-on laboratory activities would be required.

Primary Responsibilities

  • 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 (Ariba, 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 25% business travel, as needed.

Qualifications:

  • Candidates are required to hold at least Masters-level credentials in synthetic chemistry (small molecules, peptides or oligonucleotides) with at least three years of drug development experience. Ph.D.-level applicants are particularly welcome. Experience managing both the scientific and production elements of external manufacturing is preferred.

  • 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.


 

Apply Here: http://www.Click2apply.net/49cw2p6dqsvpjmk4

 

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