Associate 1, QC

Description

Who We Are

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.

ROLE

The GTAT Associate I/II 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 GTAT Associate I/II is expected to provide strong cGMP knowledge and guidance to team members and will escalate lab issues as needed. The GTAT Associate I/II 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. 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.

KEY RESPONSIBILITIES• Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management. • Contribute to efforts to compliantly perform laboratory testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. when required• 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 evaluate GTAT data during method transfer and validation work.• 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 for implementation into QC; may contribute to data review and approval of results and training of site QC analysts and data reviewers.• Initiate and/or act as investigator/owner for validation discrepancy investigations, deviations, and related corrective and preventative actions. Complete records in timely manner. • 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 (MSAT, QCAT, Technical Development, Quality Assurance, 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

Education/Experience

BA/BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 4+ years professional experience)

MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 2+ years professional experience).

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.