Technical Manager/ Senior Technical ManagerLocation 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 Technical Manager/ Senior Technical Manager, QA CMO Biologics will be responsible for managing lot release, QA system, project management and contract manufacturing oversight activities related to the manufacturing and disposition of Drug Substance (DS), Drug Product (DP), and Final Product manufactured at BioMarin’s Contract Manufacturing Organizations (CMOs). This position interacts with CMO, Quality Control, Regulatory Affairs, Planning and Supply Chain and CMC. The Technical Manager/ Senior Technical Manager, QA CMO Biologics is a highly technical position that requires expertise in cell banking and drug substance (biologics and viral vector experience preferred). Experience with fill/ finish and QA oversight of CMOs for clinical and commercial products is preferred.
The specific responsibilities of the position will include:
- Perform technical review of quality events, such as deviations, change requests, supplier notifications, as documented by contract manufacturers (external) and BioMarin contract manufacturing operations departments.
- Provide QA decision, direction, and leadership in assigned interdepartmental meetings.
- Manage and coordinate batch record review of all contract manufacturing and ensure the staff reviews executed batch records in compliance with cGMPs and BioMarin SOPs.
- Manage lot release activities and the communication of lot release schedules.
- Represent BioMarin Quality Assurance at contract manufacturer sites, including face to face visits, site audits, and Quality Review Meetings. Travel is required.
- Inform/ escalate CMO related issues internally at cross-functional meetings in a matrix organization, across multiple departments at multiple levels.
- Establish and track metrics for the department.
- Manage mid-level and large cross-functions projects the department.
Bachelor’s degree (or foreign equivalent) in Biology, Chemical Engineering, or a closely related scientific field required at a minimum. 5-10 years of progressively responsible post-Baccalaureate experience in Quality preferred, such as Quality Assurance Engineer, QA Lead, or QA Manager roles.
This role requires travel and is expected to travel up to of 20% of time.It is preferred that candidates possess 5 years of experience or education in the following:
- Hands-on experience in interacting with CMO in cGMP environment for clinical and commercial products.
- Experience in Biologics and Gene/ Cell Therapy Manufacturing, including cell banking and drug substance manufacturing. Experience with fill/ finish a plus.
- Experience with lot release activities.
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.