Associate Director/Director, Gene Therapy ManufacturingLocation Novato, California
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.
Associate Director/Director, Gene Therapy Manufacturing
The Associate Director or Director of Gene Therapy Manufacturing is responsible for leading the day to day operations of a team consisting of approximately 50 staff. This is a rare opportunity to be part of a team that is bringing Advanced Therapies to a commercial level. The successful candidate will continue to build the team’s performance and will have a goal to become a world class manufacturing organization that sets the bar for the industry.
A key deliverable for the successful candidate is to propagate a culture of ownership, pride and accountability. We are looking for an individual who is excited about learning a new approach to team building but has experience to know what works and what does not.
The successful candidate will be responsible developing staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable.
As a key member of the Gene Therapy team this position will report to the Sr. Director of Viral Vector Manufacturing.
Accountable for driving organizational change and performance towards a culture of excellence, safety, accountability, pride, ownership and collaboration. This position will oversee the commercial manufacturing team.
Accountable for plant activities, monitoring processing, maintenance of production equipment and facilities in the manufacturing areas, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices.
- Participation and decision-making regarding Process Flow and Operations for New Product Introduction (NPI)
- Effective oversight and monitoring of plant operations and activities
- Strong understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilities
- Establishes operational objectives and assignments
- Manufacturing leader for process alignment, technology transfer and product/process related initiatives
- Develops and monitors hiring plans and process
- Provides effective leadership through:
- Assessing and managing performance of direct reports, team and self
- Create an environment where productivity and efficiency are achieved and recognized
- Builds long-term development and succession planning
- Oversees performance management system behaviors
- Anticipates and addresses inspection issues that impact plant operations
- Participates in determining appropriate quality standards
- Maintains a high level of compliance through effective monitoring and reporting of key quality metrics
- Ensure timely execution of CAPA, change control and continuous improvement initiatives
- Manufacturing leader for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plant
Strategic Influence and General Look-Ahead: 2-4 years:
- Plans for the strategic needs of the facility and products, represents manufacturing on CMC teams, identifies and sponsors engineering and process improvement projects, and monitors costs
- Identify key areas for change and alignment and mobilize organization to make changes happen
- Influence and/or develop broad-based programs and initiatives to meet executive level vision and mission
- Accomplishes results through the management of a team of managers, professional employees and/or other leaders
- Develops and administers budgets, schedules, objectives and goals
- Develops standards around which others will operate and behave
- Collaborates with functional leaders to set strategy and shared objectives
- Communicates, interacts and influences Manufacturing Leadership Team and functional department heads
- S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent of education and experience
- 12+ years of directly related industry experience, including at least 10+ years with proven leadership
- Proven track record in commercial/clinical biological processing
- Ability to independently manage work, actions and expectations is essential
****Based on candidate’s qualifications, this position could be considered a Director level position.
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.