Manager/Senior Manager, Contract 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 Manager/Senior Manager Contract Manufacturing is responsible for outsourced gene therapy and bulk biologic manufacturing for early to late phase programs. He/She will lead internal and external matrix teams to make, assess, and release material on time to support clinical and commercial programs. He/She will lead internal matrix teams to support CMC program goals through various stages of program development. He/She will support tech transfer of programs to CMOs and transition from process transfer to routine manufacturing operations.
- Lead matrix teams to meet CMC goals for early and late stage gene therapy programs
- Support manufacturing of bulk biologic drug substance at a contract manufacturing organization by interfacing with internal stakeholders including Process Development, Quality Assurance, Supply Chain, Manufacturing Sciences, and Quality Control
- Communicate with members of the CMC team, and with other departments, as needed to optimize the production schedule.
- Lead troubleshooting and investigations for equipment and process failures. Follow-up on variance reports generated during production efforts.
- Write and review regulatory documentation as assigned.
- Identify potential gene therapy CMOs and lead the selection process as necessary through technical assement with input from Process Development, Regulatory Affairs, and Quality departments, the RFI/RFP bidding process, compliance audits, and contract negotiation.
- Manage contract and confidentiality agreements with the contract manufacturers, ensuring consistency between sites
- Negotiate, author, and process contracts for manufacturing and development at CMOs.
- Support budget management and efforts to manage and reduce cost of goods
- Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above.
- 50% or more of time is spent in work directly and closely related to carrying out exempt functions.
- Other duties as assigned.
- Bachelors degree in science with 8 years of directly related experience GMP manufacturing experience, including at least 3 years of management/ supervisory experience.
- Masters degree in science with 4 years of directly related GMP manufacturing experience, including at least 3 years of management/ supervisory experience.
- Strong leadership skills and experience leading matrix teams
- Working knowledge of manufacturing processes for gene therapy and biologic drug substance
- Desire to learn, grow, and be challenged
- Process development or technology transfer experience preferred.
- Excellent written and verbal communication skills.
- Negotiation skills.
- Working knowledge of desktop computers.
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.