Area Lead, Gene Therapy Manufacturing (Day Shift)
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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’s Novato commercial manufacturing facilities produce recombinant enzyme replacement therapies using perfusion and fed batch cell culture processes and multiple column purification systems. The Upstream/Cell Culture Area Lead is required to have process knowledge and equipment knowledge in their functional area. The position requires self-motivation, strong leadership and excellent communication skills. The Area Lead will provide leadership, guidance, and direction to the team within the Gene Therapy Upstream Department.
The position reports directly to a manufacturing supervisor and requires shift work, potentially including weekends, off hours, and holidays.
*This is a day shift position working 7am-6pm, Sunday – Wednesday*
- Responsible for setting daily priorities and managing daily operations within the department.
- Accomplishes tasks through direct and effective coordination and communication
- Provides direction, mentoring and hands-on training to staff
- Involved in the management and development of staff with Supervisor
- Embodies department values and sets the standards for others to operate
- Fosters an environment of compliance, work ethics, collaboration and development
- Responsible for performing daily operations within Cell Culture and Buffer preparation on the production floor, including training and troubleshooting to ensure that all operations are in full compliance and safety guidelines.
- Strong knowledge and experience in all aspects of process theory, equipment, and compliance
- Has ability to provide technical (Cell Culture or Purification) instruction and training on the various processes to their shift team
- Ability to perform operational and production tasks in respective work area
- Expected to be on the MFG floor overseeing operations minimum 80% of the time with 20% of the time dedicated to off the floor work
- Look ahead 2 weeks with the MFG production schedule and adjust priorities accordingly based on critical deadlines and staffing issues
- Facilitates the on the floor shift handoff for the start and end of the shift.
- On-the-floor process scheduling and execution Subject Matter Expert (SME)
- Assist with initiating process deviations and gathering initial details relevant to the event when needed.
- Author minor changes Standard Operating Procedures and Batch Records
- Partners with the Tech Lead and supervisor (as appropriate) in initial troubleshooting response to daily equipment and process issues.
- B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
EXPERIENCE and EXPERTISE
- 5+ years of relevant industry experience
- Working knowledge of process automation and associated process equipment
- Proven leadership, technical and communication skills
- Identify and drive opportunities for process optimization
WORK ENVIRONMENT/PHYSICAL DEMANDS
- Consists of strenuous, repetitive work. The following list of physical movements maybe used daily: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
- Independently lift, dispense, push and/or pull items with an average weight of 25 pounds.
- May require work around loud equipment.
- The use of personal protective equipment will be required.
- Requires various shift-based work and off hours
- Requires clean room gowning, Grade D and Grade C.
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.