Head of Quality Control 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 an experiencedand charismatic leader (Associate Director / Director)to oversee our Quality Control Analytical Technologies(QCAT) organization. This position reports directly to the Head of QC Analytical.
The candidate will leada team of highly dedicated QC scientists and associates responsible forQC method lifecyclemanagement activities and organizational development including
- Development, validationand 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 studiesfor product development activities
- Technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations
- Design and implementation ofmethod training tosupport knowledge transfer
- Development and implementation of performance metrics to monitor key process health and drive prioritization of improvementactivities to ensure delivery of scientifically sound and efficientQC methods
This position will collaborate with internal and external stakeholders to support BioMarin’s clinical developmentand commercial manufacturing activities. The selected candidate with partner with Process Sciencesto establish commercial method performance targets todrive effective decisions regarding QC method readiness in alignment with BioMarin’s stage gate process.Additionally, this position will collaborate withRegulatoryand Product Quality to supportCMC deliverablesincluding content authoring and review ofQuality owned sections for INDs/IMPDs, BLAs/MAAsand HA information requests and communications.
- Oversee staff development and department budget
- Implement key performance metrics to monitor process health and assist with prioritization of improvement activities
- Oversee activities associated with validation and transfer ofQC Methods used to support BioMarin’s in-process, release and stability testing programs including to CTOs, in-country test labs and strategic partners.
- Develop and implement policies, standards and procedures to ensure operations are executed in full compliance withcGMPs and multi-national regulations
- Provide technical support for site and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)
- Write, review and approve 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.
- Work collaboratively with Manufacturing, QA and QC to ensure timely suupport of issues
- Partner with Product Quality and Regulatory to support CMC deliverables
- Bachelor of Science with at 15 years of relevant experience in biotechnology/pharmaceutical industry
- 10 years of experience in team leadership rolesoverseeing organization and staff development
- Experience with analytical method development, validation and transfer as well as product characterization and analytical comparability
- Prior experience with authoring and review of Quality owned regulatory filing sections (e.g. JOS, comparability, method summaries, etc.)
- Comprehensive knowledge of current Good Manufacturing Practices (cGMPs) and multi-national regulations
- Ability to travel up to 20% of the time
Preferred Experience, Special Skills, Knowledge
- Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10 years of relevant experience is preferred
- Strong leadership skills and ability to effectively communicate up,down and across the organization
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment
- Excellent written, verbal communication and presentation skills
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
- 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.