Associate, QCVVALocation Novato, California Workstyle Onsite Only Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 Associate is responsible for providing technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance, drug product under cGMP guidelines and procedures. The QC Associate is expected to provide strong cGMP knowledge and guidance to team members and will escalate in the lab issues as needed. The QC Associate is responsible for supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods, and supporting the preparation of regulatory submission documents and, where required, supporting the on-time release, stability, and non-routine testing of pharmaceutical drug substances and drug product. Strong written and verbal communication skills are essential.
Presentation of laboratory results and conclusions, being a key subject matter expert for regulatory inspections, training and educational development of other staff are also expected. Experience developing or executing mammalian cell culture methods is highly preferred.
- Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
- Lead efforts to compliantly perform laboratory testing of in-process samples, finished product, non-routine samples, packaging and stability, etc.
- Become Subject Matter Expert in analytical methods including HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and Bioassays, PCR, etc.
- Provide technical expertise for analytical methods in QC, support the maintenance of method, and analytical equipment performance.
- Analyze, Trend, and review quality control non-routine, release, and stability testing data.
- Experimental design, execution, and report writing—often for direct submission to pharmaceutical regulatory agencies.
- Develop, optimize, validate and troubleshoot analytical test methods.
- Draft and revise QC SOPs; contributes to data review and approval of results.
- Initiate and/or act as investigator/owner for laboratory investigations, deviations, and related corrective and preventative actions. Complete records in timely manner.
- May have one or more direct reports and is expected to provide technical and cGMP knowledge and guidance to the entire team.
- Maintain the laboratory in an inspection-ready state including support of equipment management.
- Interact directly with regulatory agency inspectors during audits.
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives.
- Other duties as assigned.
- 4-year science degree in Biology, Molecular Biology, Analytical Chemistry, Biochemistry, or similar disciplines is required.
- 5-7 years of experience, preferably in a GMP environment.
- Cell based experience required. Cell-based work in gene therapy a plus.
- HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR experience a plus
- Experience reviewing and executing on study protocols, participating in method optimization, transfer and validation studies a plus.
- Experience with working with mammalian cell cultures is not required but is highly preferred.
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.