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Analyst, QC VVA

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Jun 28, 2022

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

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.

Role

The QC Analyst is an entry level role and is responsible for providing support to the on-time release, stability and non-routine testing of the pharmaceutical drug substances and drug product in a cGMP environment. The QC Analyst is responsible for providing support to activities related to sample and/or lab equipment management.  The QC Analyst is responsible for supporting analytical method development, assisting with troubleshooting work and executing validation and transfer protocols, supporting the writing and reviewing of protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods and when necessary providing support in the preparation of regulatory submission documents.  This role may include overtime and shift work.

 

Key Responsibilities

  • Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
  • Monitor lab equipment for Calibration needs, monitoring and tracking of issues related to instrumentation.
  • Support the scheduled testing by ensuring the required reagents and glassware are stocked appropriately.
  • Maintain the laboratory in an inspection-ready state
  • Perform Analytical testing 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. in a cGMP environment.
  • Assist with preparation of protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
  • Develop, optimize, validate and troubleshoot analytical test methods
  • Act as technical resource (SME) and train other analysts in areas of expertise
  • Evaluate results against defined acceptance criteria
  • Conduct and document laboratory investigations and deviations to completion
  • Support sample and record management for testing within the group and at CRO/CTO’s
  • Manage shipment of materials and samples to other BioMarin sites, CRO/CTO’s, or to in-country testing labs
  • Interact directly with regulatory agency inspectors during audits
  • Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
  • Other duties as assigned
Requirements:
• BA/BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 5 years professional experience)
• MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
• The optimal candidate will have both HPLC and cell based experience and cGMP quality control experience preferred.
• Experience with platforms such as Empower, ChemStation, LabWare LIMS, SpectraMax, and Veeva preferred.
• Experience with HPLC, Ultra-High Pressure Liquid Chromatography, Capillary Gel Electrophoresis, Multi-Angle Light Scattering, Gel Electrophoresis, and SDS-Page.

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.

Company

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.

Company info
Website
Location
California
United States

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