QC Analyst / Sr. AnalystLocation Novato, California Apply
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 Analytical Technologies team is a high-performing and team-based organization, in which colleagues are flexible, multi-skilled and empowered to solve problems. Candidates must have a high level of energy, self-motivation, endurance, and organizational skills.
- Be able to perform biochemical, physical, and chemical testing under minimal supervision and be compliant with cGMP guidance.
- Good record keeping, organizational, written, and verbal communication skills are essential.
- Will be responsible for the timely completion of assignments.
- Must be able to execute various analytical activities, including method validation, transfer, troubleshooting, and special studies.
SKILLS/ KNOWLEDGE/ BEHAVIOURS:
- The role will potentially perform a broad range of analytical testing for biologics and small molecule samples including but not limited to the following: HPLC, SDS-PAGE, UV, and CE.
- Evaluate results against defined test acceptance criteria and product specifications.
- Optimize, validate, transfer, and troubleshoot analytical test methods.
- Conduct and document laboratory investigations to completion.
- Draft and revise QC SOPs.
- Act as subject matter expert and train other analysts in areas of expertise.
- Familiar with the use of Veeva, LIMS and TrackWise systems.
- Provide support to maintain lab supply and keep the lab in an inspection-ready state.
- Demonstrate adaptability and flexibility to support a growing team.
- Possess excellent communication skills both written and verbal.
- Interface with other departments and contractors as necessary.
B.S. in a scientific discipline.
- 1+ year of relevant laboratory experience for consideration of the QC Analyst position and 5+ years for the Sr. Analyst position.
- Ability to work independently and meeting established timelines.
- Comfortable with coordinating the activities with other team members.
- At least one year in a cGMP laboratory; QC experience is preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.