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QC Sr. Analyst, Gene Therapy Analytical Technologies

BioMarin Pharmaceutical Inc.
Novato, California
Start date
Nov 25, 2022
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Job Details

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 Analyst / Senior Analyst is responsible for performing on-time release, stability, and non-routine testing of pharmaceutical drug substances and drug product under cGMP guidelines and procedures.  The QC Analyst / Senior Analyst is responsible for carrying out analytical method development and troubleshooting work, executing validation and transfer protocols, writing and reviewing protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods, support the preparation of regulatory submission documents.  The QC Analyst / Senior Analyst is expected to demonstrate strong cGMP and compliance acumen.  The QC Analyst / Senior Analyst can work independently under minimal direction while completing work assignments.  This role may include overtime and shift work.

Presentation of laboratory results and conclusions, becoming 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.
  • Perform Analytical testing compliantly incl: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based bioassays, PCR, etc.
  • Testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. under cGMP guidelines and procedures.
  • Provide technical expertise for analytical methods in QC, support the maintenance of method and analytical equipment performance
  • Prepare protocols, summaries, and reports—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.
  • Act as technical resource (SME) and train other analysts in areas of expertise
  • Evaluate results against defined acceptance criteria
  • Conduct, support and document laboratory investigations and deviation investigations to rapidly identify the root cause and to establish effective corrective action(s) with minimal delay
  • Maintain the laboratory in an inspection-ready state
  • Support sample and record management for testing within the group and at CRO/CTO’s
  • Interact directly with regulatory agency inspectors during audits
  • Interface with other BioMarin departments (MSAT, QCAT, Technical Development, Quality Assurance, Facilities, etc.) and contractors as necessary
  • Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
  • Other duties as assigned


  • A 4-year science degree in Biology, Molecular Biology, Analytical Chemistry, Biochemistry, or similar disciplines is required.
  • 0-3 years of related experience, preferably in a GMP environment.
  • Cell based experience required. Cell-based work in gene therapy is a plus.
  • HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.
  • Experience reviewing and executing on study protocols, participating in method optimization, transfer and validation studies is a plus.
  • Experience working with mammalian cell cultures is not required by 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. 


BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

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