Associate 1, QCLocation 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.
This position will assist with the management of QC contract testing and cell bank production related activities. Key responsibilities may include:
- Organize QC contract testing and cell bank production activities and serve as point of contact for contract laboratories and internal BioMarin QC groups as it relates to contract testing activities
- Establish effective communication and collaborative relationships with other functional groups, key stakeholders, and external contacts.
- Organize and track contract testing and cell bank testing/production activities. Maintain databases for tracking requests and activities and provide updates to management and QC labs as necessary.
- Generate, revise, and maintain Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
- Generate legal contract requests and purchase orders for contract testing and cell bank testing/production.
- Initiate change requests (CR) for new cell bank production and SOP revisions using TrackWise system.
- Perform contract lab performance evaluations and present evaluations during review meetings.
- Prepare and evaluate testing and cost metrics.
- Maintain cell bank inventories, coordinate cell bank vial shipments to/from offsite biorepository.
- Assist with shipment of samples and reagents to contract labs.
- Manage and maintain positive relationships with contract testing lab partners.
- Support onsite regulatory agency, partner and QP inspections.
- At least 5 years in a cGMP laboratory; quality control experience preferred, but not required.
- Experience in dealing with contract testing laboratories is highly preferred.
- Well-developed laboratory skills for analysis of pharmaceuticals and biopharmaceuticals.
- Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and detailed instructions on new assignments.
- Proficiency in MS Applications
- Excellent communication, organizational and project management skills.
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
B.S./B.A. degree with 5 years of experience in pharmaceutical industry, including some work in a laboratory setting. Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies. Excellent written and verbal communication skills
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.