Director, 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 an experienced and dynamic leader to oversee our global Quality Control Analytical Technologies (QCAT) organization. This position reports directly to the Head of Global QC.
The candidate will have full responsibility for department budget and staff development and will lead a team of highly dedicated QC scientists and associates responsible for QC method lifecycle management activities and organizational development including
- 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
- 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
This position will collaborate with internal and external stakeholders to support BioMarin’s clinical development and commercial manufacturing activities. The selected candidate with partner with Process Sciences to establish commercial method performance targets to drive effective decisions regarding QC method readiness in alignment with BioMarin’s stage gate process. Additionally, this position will collaborate with Regulatory and Product Quality to support CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and 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 of QC Methods used to support BioMarin’s in-process, release and stability testing programs including to contract testing organizations (CTOs), in-country test labs and strategic partners.
- Develop and implement policies, standards and procedures to ensure operations are executed in full compliance with cGMPs 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 site QC to ensure timely support 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 roles overseeing 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
- Excellent written, verbal communication and presentation skills
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
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.