Sr. Engineer 1, MSAT Technology TransferLocation 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 Manufacturing Sciences and Technology (MSAT) Technology Transfer Sr. Engineer 1 position is responsible for the successful planning, execution, and technical support of manufacturing process scale-up and technology transfer project tasks/activities, in which drug substance and drug product bioprocess unit operations are transferred from Process Sciences to Manufacturing in order to produce quality product at cGMP manufacturing scale in support of both clinical and commercial programs. Additionally, the MSAT Technology Transfer Sr. Engineer 1 position may be responsible for other manufacturing-technology-related projects as assigned, such as the implementation of new manufacturing equipment or raw materials, or the management of complex manufacturing process improvements/changes requiring cross-functional oversight.
The ideal candidate for the MSAT Technology Transfer Sr. Engineer 1 position will have direct working experience with bioprocess scale-up and technology transfer, have strong project management skills and the ability to direct multiple projects concurrently, be able to effectively lead and influence large cross-functional teams without authority, have experience in working with Chemistry, Manufacturing, and Controls (CMC) teams, and have extensive technical knowledge and expertise in the manufacturing production of protein and/or gene therapy (viral vector) products so as to provide guidance and drive quality decision-making during project execution and to achieve overall project success and process robustness.
- Perform various scale-up and technology transfer project tasks/activities such as evaluating process scale and manufacturability, evaluating facility fit and equipment capability, and determining manufacturing process control strategy
- Lead stage-appropriate technology transfer teams and associated projects in support of New Product Introduction, Process Performance Qualification (commercialization), and Product Lifecycle Management
- Lead stage-appropriate CMC partner teams and associated projects in support of New Product Introduction, Process Performance Qualification (commercialization), and Product Lifecycle Management
- Lead manufacturing-technology-related projects/initiatives as assigned (e.g., implementation of new equipment, implementation of new raw materials, implementation of process improvements/changes, etc.)
- Perform and document formal risk assessments as needed
- Generate technical reports as needed
This position is required to successfully complete projects in a timely manner to support key company goals and objectives as they relate to clinical and commercial products. Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance / drug product meeting BioMarin and Regulatory Agency requirements.
- 5+ years of relevant industry experience in pharmaceutical or biopharmaceutical manufacturing
- 2+ years of relevant experience in a position utilizing formal project management with a proven track record of successfully leading, facilitating, managing, and delivering on large, cross-functional projects/initiatives
- Experience with cGMP-regulated manufacturing environments, with exhibited knowledge of a variety of upstream and downstream bioprocess unit operations and general familiarity with systems and equipment used in the manufacture of drug substance and drug product
- Understanding of FDA & European regulatory requirements and guidelines
- Ability to speak to, present information/data to, and gather consensus/buy-in from a variety of audiences/stakeholders
- Experience with electronic quality management systems such as TrackWise, LIMS, Veeva, etc.
BS in Life Sciences with 2-5 years of experience or MS with 0-3 years of experience in Manufacturing Sciences and Technology, Process Engineering, or cGMP Manufacturing
- BA/BS degree in a technical discipline (physical, engineering, chemical, biological sciences, etc.) is required
- Project Management Professional (PMP) certification is a plus
- Certified Six Sigma Green Belt (CSSGB) certification is a plus
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.