Supervisor, Gene Therapy Pilot Plant

Location:  Novato, California Category: Manufacturing

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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.

Key responsibilities 

  • Plan and execute daily activities in the clinical MFG facility during production periods.
  • Coordinate the support of internal and external resources to accomplish production goals with minimal oversight. 
  • Oversee a manufacturing shift including training, scheduling of vacation time, daily assignments and Perform document reviews and own some deviations and change controls. Provides direction and hands-on training for staff.
  • Work with cross-functional partner groups to resolve technical and logistical challenges.
  • Fosters an environment of safety, compliance, strong work ethic and ongoing learning
  • Lead projects related to continuous improvement, operational readiness, and campaign startup/close out during non-production periods and support activities including non-clinical development runs, recipe programing and testing, and maintenance/calibration.

Note: The position may require off hours support as required. Shift work potentially includes weekends, off hours and holidays. Flexible scheduling including remote work is possible when pilot plant not in production.

Requirements

Leadership Skills

  • Ability to independently manage work, actions and expectations.
  • Ability to manage and develop the staff by discussing individual development plans, providing feedback, and setting clear and attainable goals for staff.
  • Strong organizational and communication skills.
  • Understand the strategic decisions and be able to adapt changes as needed.

 

Process Knowledge 

  • Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
  • Ability to troubleshoot, identify issues and support resolutions with technical groups
  • Required to perform ongoing operational tasks in respective work area
  • Uses scientific thinking and decision making in daily work

Technical Competency

  • Able to handle large-scale bioprocessing including aseptic cell culture, single use bioreactor, or downstream chromatography operations.
  • Have a strong foundation in GMP principles and be able to articulate and defend their decisions within a quality framework.
  • Capable of drafting and reviewing standard operation procedures, batch records and other technical documents.

 

Education/Experiences

B.S. degree in life sciences, engineering, applied physics, etc., or acceptable equivalent combination of education and experience.

6+ years of directly related industry experience, including 2+ years with proven leadership role. Candidates with M.S. or equivalent degree with less years of related industry experience may be considered.

Previous experience with gene therapy manufacturing is a plus.

Knowledge and experience with process development and technical transfer is a plus.

About the Gene Therapy Pilot Plant

The gene therapy pilot plant is responsible for delivering BioMarin’s extensive gene therapy pipeline to the clinic.  We are part of the Process Science group within Technical Operations (TOPS) and work closely with the rest of the Process Science group to execute early phase manufacturing processes to support large scale development needs and/or provide GMP material for early phase clinical use.  The team was founded in 2020 and expects to grow with the needs of BioMarin’s clinical pipeline.



PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.