Supervisor, Manufacturing (Purification)
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.
Summary of Responsibilities
This position is a great opportunity to join a talented and high-energy manufacturing team that has seen a lot of growth and opportunity over the last few years. The role is responsible for leading and developing a shift of hourly operations staff, crafting a culture of safety and compliance, and collaborating with peers. As the Supervisor, you are accountable for production activities, adherence to schedule, maintaining production equipment, ensuring inspection readiness, and ensuring compliance with current Good Manufacturing Practice (cGMP) regulations and written procedures. The position may require occasional "off hours" and holiday support as needed. As the leader of a shift team, you will provide direction such that department visions, missions, and objectives are met.
The Manufacturing Supervisor leads a team within the Purification area.
- Responsible for daily operations on the production floor, including scheduling, staffing, training, and material use.
- Deep understanding and experience with large scale purification is preferred.
- Ability to thoughtfully troubleshoot complex systems and work towards resolution of problems with support groups.
- Displays good judgement on when to escalate problems in the area and when to collaborate with subject matter experts.
- Responsible for interviewing, selecting and training staff to maintain a full team.
- Spends 75% of the time on the manufacturing floor leading operations, providing leadership, and performing real-time reviews of batch records and logbooks
- Provides effective leadership through:
- Assessing and handling performance of direct reports, team and self.
- Individual goal setting and performance reviews with direct reports.
- Supports development, mentorship, and continued learning of direct reports.
- Engages their team by involving them in decisions.
- Foster’s an environment of positivity and teamwork
- Uses their team to get results.
- Initiates process deviation records and change requests.
- Works with department manager and/or Quality contact to determine appropriate CAPAs related to process deviations.
- Understands quality in a GMP environment and displays good judgement when faced with responding to problems during production.
- Completes review of quality documents-—logbooks, batch records, training forms.
- Helps to build a culture of continuous improvement and continuous learning.
- Regularly recommends improvements and helps to prioritize them within the team.
- Applies data analysis tools and methodologies and to solve systematic problems.
- Accountable for successful completion of operations and results on your 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.
- S. degree in Life Sciences, Engineering, other technical studies, 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 demonstrated leadership role
- Technical expertise in large scale processing with various complex purification platforms
- Experience with cGMP's in a biologics manufacturing facility
- Strong interpersonal, collaboration, and communication skills.
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.