Supervisor, Quality Control Viral VectorLocation 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 QC Viral Vector (QC VVA)Supervisor possess is responsible for overseeing day-to-day laboratory activities and ensuring the laboratory is always in an inspection-ready state. The QC Supervisor is responsible for supervising the work of several analysts, performing and reviewing a wide variety of tests/results and reagent preparation. The QC supervisor is responsible for completing assignments in a timely manner, for troubleshooting, and for follow-up on testing issues to support the manufacturing process for gene therapy products.
The main areas of QC VVA activity are:
- Communication of priorities to staff and oversight of day-to-day laboratory operations
- Ensuring GXP compliance within the laboratory and maintaining an investigation-ready state
- Data review and LIR and deviation investigation support
- Manage and develop the performance of direct reports
- Represent the functional area in meetings and compliance activities
- Ensure compliance with 21 CFR, USP, EP, and ICH guidelines, as applicable
- Assign tasks, manage and ensure adherence to laboratory schedules
- Provide cGMP expertise for all aspects of testing and laboratory operations within the laboratory.
- Supervise operations in the QC VVA laboratory during applicable shift(s)
- Ensure the team is compliant to GXP and safety and environmental standards
- Represent team needs on behalf of QC VVA for cross-functional groups, testing needs, and project teams.
- Manage and develop the performance of direct reports by setting clear performance goals and providing timely feedback. Address disciplinary and performance issues in a timely manner.
- Collaborate with Managers, Scientists, and Head of QC VVAto ensure successful QC Laboratory operations
- Develop and maintain both internal and external relationships
- Author and review documents such as standard operating procedures and TrackWise records.
- Support investigations (LIRs and Deviations), change requests, CAPAs.
- Ensure execution of QC VVA laboratory activities in strict accordance with Standard Operating Procedures, GMP, and Regulatory requirements.
- Schedule and/or deliver training to the QC VVA personnel to ensure staff can perform assigned tasks correctly, safely, and compliantly
- Utilize process, technical knowledge and investigation skill to identify and rectify departmental issues
- Contribute to the improvement of all QC VVA systems and processes
- Accountable for successful completion of operations and results on assigned shift.
- Executes on objectives and goals to support a positive, efficient, and motivated team.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Other job responsibilities as assigned
BS degree in a biological of biochemical science and at least 6 years of experience in a pharmaceutical laboratory. At least 2 years of QC laboratory experience is highly preferred. MS degree with at least 3 years of QC/GMP experience.
The candidate must be a motivated employee capable of working in a fast-paced environment. Experienced managing direct reports and processes is preferred. Strong time management and organizational skills is required. Strong people skills are required. Detailed knowledge of quality management systems, cGMPs, expertise with QC principles and compliance requirements are highly preferred. Excellent Documentation, written and verbal communication skills are essential. Computer literacy is required and experience with LIMS is highly preferred. Must have a quality service attitude and focus, exhibit flexibility, and willingness to work additional hours to meet production or laboratory requirements.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.