Area Lead, Manufacturing
Area Lead, Manufacturing
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 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 and department.
The position reports directly to a manufacturing supervisor and requires shift work, potentially including weekends, off hours, and holidays.
- 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 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.
- Bachelor’s degree in science related area or engineering or Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
EXPERIENCE and EXPERTISE
- 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 on a daily basis: 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
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.