Supervisor, Manufacturing Gene Therapy (Day Shift)
Location :Novato, California
Workstyle :Onsite Only
With accelerated review underway in the United States and Europe for our Hemophilia A drug, a second gene therapy program entering the clinic for PKU patients, and a third program in late research for Hereditary Angioedema, BioMarin continues to pioneer innovative approaches to treating rare diseases. Our commitment to gene therapy is further underscored by having developed the first and largest gene therapy manufacturing facility in the world. The scientific possibilities and the hope we offer to patients with rare diseases is enormous.
BioMarin is a midsize biotechnology company with a market cap of approximately 18 billion. Over the course of our 22 year history we have successfully launched 7 drugs for the treatment of rare diseases. Our success is due to our scientific rigor and our ability to leverage multiple therapeutic modalities. BioMarin is based in the San Francisco Bay Area and offers a comprehensive relocation program.
Check out the traits we’re looking for and see if you have the right mix.
- Decision Making
- Intellectual Curiosity
- Patient Focused
- Results Oriented
- Pioneering Science
- Cross Functional Collaboration
- Willing to try new ways to look at problems
Health & Wellness Programs
" BioMarin has this, in their own DNA, an approach: they only work on projects for which they know the underlying biology."Lon C., Chief Scientific Officer
"We’ve got to understand: What are the problems other people are trying to solve? And do we have a better way of fundamentally doing that?"Brinda B, GVP, Corporate and Business Development
Supervisor, Manufacturing Gene Therapy
The roleis responsible for leading and developing a shiftof hourly operations staff, creating a culture of safety and compliance, maintaining training objectives,and collaborating with peers. The Supervisor is 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. The position may require occasional "off hours" and holidaysupport as required.
The shift schedule for this position is Day Shift:Wednesday-Saturday, 7am – 6pm.
The Manufacturing Supervisor is responsible for one of the teams/shifts within theGene Therapy Upstream Department; ensuring safety and compliance with cGMPs are maintained at all times. Ensures the efficiency of material, processing requirements, equipment function and personnel performance for day-to-day operations. As a leader of a shift, provides tactical and supervisory leadership so that mission, vision, and department objectives are met.
- Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance and safety guidelines.
- High level of understanding and experience with Upstream and Buffer processes, automation controls, compliance and theory.
- Technical proficiency in area of responsibility and ability to provide technical instruction and training processes to staff and team
- Troubleshoot, identify issues and support resolution with support groups
- Ability to perform operational tasks in respective work area
- Responsible for interviewing, selecting and training staff to maintain workforce
- Provides effective leadership through:
- Assessing and managing performance of direct reports, team and self
- Individual goal setting and performance reviews
- Manage performance issues, development and enforcing policies
- Ensure the use of safe and compliant work practices and behaviors
- Issue deviations and change requests and work with depart manager and/or QA professional to evaluate CAPA, assist with closure and implement actions
- Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs
- Core quality commitments (logbook and BR review, maintain training compliance, assist with revision of procedures and batch records)
- Ensure staffing levels and skill sets are maintained and training is in compliance
- Oversee floor staff and process operations, identify and coordinate repairs, identify and assist with deviations, review batch records, author change requests for improvements.
- Recommends actions and regularly exercises discretion in regard to processes within work area
- Uses data analysis tools and methodologies and applies judgment to solve systematic problems
- Accountable for operations and results on an assigned shift
- Applies broad processing knowledge and experience to complete work and develop team
- Executes on objectives and goals to support a positive, efficient and motivated team
- Plans and oversees the daily activities of a work team
- Assigns tasks appropriately to ensure accurate completion is achieved
- Provides training, guidance and development to others
- Spends a portion of time performing the work with the team
- Manages a team of processing associates
- B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
PREFERRED EXPERIENCE AND QUALIFICATIONS
- 6+ years of directly related industry experience, including at least 2+ years with proven leadership role
- Technical expertise in large scale processing with various complex cell culture platforms
- Experiencewith cGMP's in a biologics manufacturing facility
- Ability to independently manage work, actions and expectations is essential
- Strong organizational, collaborating and communication skills
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.
About our location
Meet Our Team
From internationally renowned scientists to patient advocates, BioMarin Hemophilia has brought together the right people.Read More
In the News
BioMarin has entered into a preclinical collaboration and license agreement with DiNAQOR, a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies.Learn More