Jobs and Careers

QC Associate I, QCA (Cell and Molecular Biology)

United Statesfull_timeVerifiedPosted 30 Sept 2024

About the role

Our Culture

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.

TITLE QC Associate I, QC Analytical SUMMARY The Quality Control Analytical (QCA) 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. RESPONSIBILITIES

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 incl: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based 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

EXPERIENCE Required Skills:

5-7 years of experience, preferably in a GMP environment.
Cell based experience required. Cell-based work in gene therapy a plus.

Desired Skills:

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 no