Scientist 2 / Sr. Scientist, QC Analytical TechnologiesLocation 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.
BioMarin is seeking a Molecular Biology or Biochemistry Scientist within the QC Analytical Technologies group (Scientist 2 / Senior Scientist). Department objectives include:
- Development, validation and transfer of analytical/bioanalytical methods used in BioMarin’s QC clinical and commercial testing operations supporting in-process, release and stability testing
- Design and execution of special studies for product development activities
- Technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations
- Training of QC staff across the organization
- Design and implementation of method training to support knowledge transfer
- Development and implementation of performance metrics to monitor key process health and drive prioritization of improvement activities to ensure delivery of scientifically sound and efficient QC methods
The candidate will play a key role in product development and manufacture. Essential to this role is a strong knowledge base and broad expertise in biochemistry or molecular biology and the ability to lead and mentor scientific staff and collaborate with cross functional team members to execute product development. The candidate will be required to manage scientific development, implement and maintain plans and strategies to support manufacturing, provide scientific expertise, prepare reports and keep upper-level management informed of progress and problems. Previous experience with potency and cell-based bioassay methods for protein therapeutics is highly desirable. The candidate must have five years of experience leading teams and five years of experience in a GMP environment.
This position offers significant opportunity to develop scientific and managerial skills in a biotechnology environment. The selected candidate will work in a creative, fast-paced environment, interacting with scientists or individuals from diverse backgrounds. We are looking for a team player with a record of contribution to process optimization/validation, excellent interpersonal skills, and experience in managing and mentoring analysts. 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.
- The scientist will potentially supervise up to five analysts.
- Perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs including to CTOs, in-country test labs and strategic partners.
- Provide technical support for site and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)
- Draft Analytical Development and Quality Control SOPs, specifications, method validation and verification protocols and technical reports
- Support Annual Product Review (APR) and Annual Report (AR) activities
- Identify and address technical and validation gaps in analytical methods and QC testing in preparation for product commercialization.
- Lead assay lifecycle management efforts
- Work collaboratively with Manufacturing, QA and QC to ensure timely suupport of issues
- Partner with Product Quality and Regulatory to support CMC deliverables
- BS in a scientific discipline with at least 14 years of relevant laboratory experience.
- MS in a scientific discipline with at least 10 years of relevant laboratory experience.
- PhD in a scientific discipline with at least 5 years of relevant laboratory experience.
- Proficient in use of a computer (e.g., proficient in Windows, Microsoft Word, Excel, statistical and analytical software)
- Familiarity with a wide range of analytical technologies such as HPLC, ELISA, and/or bioassays.
- Experience in designing and executing larger projects and studies.
- Strong critical thinking/problem solving skills.
- Good written and verbal skills.
- Knowledge of current Good Manufacturing Practices (cGMPs).
Preferred Experience, Special Skills, Knowledge
- Experience with analytical method development, validation and transfer as well as product characterization and analytical comparability.
- Experience in development, optimization, validation, execution, and troubleshooting of cell-based bioassays.
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.