QCAT Analyst or QCAT Associate Scientist
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.
The QC Analytical Technology (QCAT) Analyst/Associate Scientist is responsible for laboratory work in support of studies throughout the lifecycles of pharmaceutical drug substances and drug products in a cGMP environment. They are responsible for providing support to activities related to analytical method development, assisting with troubleshooting work, 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, assist in the preparation of regulatory submission documents. When required, the analyst/associate scientist also assists in the on-time release and stability testing of pharmaceutical drug substances and drug product.
This position reports to the QCAT Scientist/Manager.
3 – 5 years industry experience required for QCAT Analyst role.
> 5 years industry experience for Associate Scientist role. Cell Culture/Bioassay experience required for Associate Scientist role. Experience with HepG2 cells preferred, but not required .
- Analytical testing performed by the lab incl: HPLC/UPLC, UV Spectrophotometry, plate based assays including ELISAs and cell based Bioassays, capillary electrophoresis, qPCR, etc
- Provide technical expertise for analytical methods in QC, support the maintenance of method and analytical equipment performance
- Perform primary review of QC raw data and trend results. Evaluate results against defined acceptance criteria
- Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- Draft QC SOPs
- Act as technical resource (SME) and train other analysts in areas of expertise
- Conduct, support and document laboratory investigations to rapidly identify the root cause and to establish effective corrective action(s) with minimal delay
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Maintain the laboratory in an inspection-ready state
- Interact directly with regulatory agency inspectors during audit
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.