Supervisor, Downstream Manufacturing
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.
The shift schedule for this position is Night Shift: Sunday-Wednesday, 6pm – 7am.
The Manufacturing Supervisor is responsible for one of the teams/shifts within the biologics downstream 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 or purification platforms
- Experience with 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.