QC Associate I, QCA (Cell and Molecular Biology)

Location:  Novato, California Category: Quality

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Description

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 not required but is highly preferred.
 
EDUCATION
  • 4-year science degree in Biology, Molecular Biology, Analytical Chemistry, Biochemistry, or similar disciplines is required.
 
EQUIPMENT 
N/A 
 
CONTACTS 
QC, QA, MSAT, AS, MFG 
 
SHIFT DETAILS 
M-F 8-4:30pm
 
ONSITE, REMOTE, OR FLEXIBLE 
Onsite 4 days per week, remote 1 day per week 
 
TRAVEL REQUIRED 
Travel is not required for this position 


Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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