Sr. Specialist – Manufacturing Operations’Location Novato, California
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.
Do you want to have an opportunity to make a difference? Then we would love to have you on the Galli Manufacturing Continuous Improvement Team. Galli Manufacturing produces enzyme replacement therapies for patients with rare genetic disorders and we’re currently deploying a 5-year transformational change initiative to realize our vision of ‘Achieve Manufacturing Excellence Every Day, Every Lot, for Every Patient’.
The Sr. BioProcess Engineer will work closely with representatives from the Floor Staff, Manufacturing Science & Technology, Engineering, Automation, Validation, etc. to support day to day plant operations, drive CAPA selection and closure, and execute continuous improvement projects. As a member of our downstream process team you will influence technical strategy and project prioritization.
You will be considered a manufacturing focused technical (SME) across upstream and downstream processes. As a SME, you will know how the components of any BioProcess Manufacturing system (procedures, batch records, automation, equipment, scientific processes) work in combination with the operator to deliver quality product supply. You will leverage your creativity and technical acumen to troubleshoot in real time and support complex high impact investigations. You will set objectives and create actions plans to transform and mature three facilities and five products to drive commercialization, compliance, and continuous improvement.
We will work together to strengthen core skills and capabilities to not only make you successful in this role, but also prepare you for future opportunities. Your efforts will lead to the development of mature processes within the Galli Manufacturing organization improving the lives of our manufacturing associates and improving our ability to reliability supply the patients we serve.
- 7+ years of relevant experience in pharmaceutical or biopharmaceutical manufacturing
- 5+ years of supporting any of the following: bioreactor/fermentation operations, media/buffer operations chromatography operations, CIP, SIP, disposables, and other aspects of downstream processing in a ‘front-line’ capacity (Design, Change Control, Corrective/Preventative Actions, Troubleshooting, etc.)
- B.A./B.S. in Science, Engineering, or acceptable equivalent combination of education and experience
- Subject matter expert in drug substance biopharmaceuticalmanufacturing and associated engineering applications
- Familiarity with the underlying scientific principles that drive biologic protein expression, recovery, purification, and formulation
- Understanding of FDA/EMEA cGMP guidelines pertaining to biopharmaceutical or aseptic processing and GMP compliance
- Proven mastery ofproject management, leadership and communication skills
- Self-motivated individual, able to work well in a team environment
- Seasoned leader capable for managing significantly complex technical issues with minimal over site.
- Demonstrated Ability to
- Handle multiple tasks concurrently and be flexible and adaptable, as needed
- Meet deadlines and drive projectswithout direct authority as the primary change agent
- Strong technical writing ability, with extensive experience in authoring change controls and standard operating procedures.
- Expert at coaching others to drive for results; guides team members in the way that best suits their work style, actively seeking to offer support while nurturing self-directedness
- Exceptional facilitator, promoting effective decision and mutual understanding among cross-functional and executive level participants, while holding key decision makers accountable.
- Proven mastery at generating concise and encompassing problem statements
- PMP Certification
- Six Sigma Certification (Green or Black Belt)
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.