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QC Associate I, QCA (Cell and Molecular Biology)

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BioMarin Pharmaceutical Inc.

2mo ago

  • Job
    Full-time
    Senior Level
  • Science
  • Novato
  • Quick Apply

AI generated summary

  • You need 5-7 years in a GMP lab, cell-based experience (gene therapy a plus), HPLC/UPLC, ELISA, PCR skills, and a 4-year science degree in a relevant field.
  • You will conduct laboratory testing, ensure compliance with cGMPs, analyze data, develop methods, draft SOPs, lead investigations, maintain readiness for audits, and support continuous improvement initiatives.

Requirements

  • 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.
  • 4-year science degree in Biology, Molecular Biology, Analytical Chemistry, Biochemistry, or similar disciplines is required.

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

FAQs

What is the role of the QC Associate I in the Quality Control Analytical team?

The QC Associate I is responsible for providing technical leadership in the performance, validation, optimization, development, troubleshooting, and transfer of analytical evaluations for drug substances and drug products under cGMP guidelines.

How many years of experience are required for this position?

The position requires 5-7 years of experience, preferably in a GMP environment.

What educational background is required for the QC Associate I role?

A 4-year science degree in Biology, Molecular Biology, Analytical Chemistry, Biochemistry, or a similar discipline is required.

Is cell-based experience necessary for this role?

Yes, cell-based experience is required, and experience in gene therapy is considered a plus.

What are some desired skills for this position?

Desired skills include experience with HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, and PCR experience.

What is the work schedule for this position?

The work schedule is Monday to Friday, from 8:00 AM to 4:30 PM.

Is the position onsite or remote?

The position is primarily onsite, requiring four days of onsite work and one day of remote work per week.

Is travel required for this position?

No, travel is not required for this position.

What are the responsibilities regarding regulatory inspections?

The QC Associate I is expected to present laboratory results, act as a key subject matter expert for regulatory inspections, and support the preparation of regulatory submission documents.

What departments may the QC Associate I interact with?

The QC Associate I may interact with other departments such as Manufacturing, Quality Assurance, Facilities, etc.

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BioMarin Pharmaceutical Inc.

We transform lives through genetic discovery.

Science & Healthcare
Industry
1001-5000
Employees
1997
Founded Year

Mission & Purpose

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact.