Manufacturing Operations Team Lead
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.
Operations Team Lead is a role based in either upstream cell culture, downstream purification or support services.
All biotechnicians and shift leads from respective shifts will report to the Operations Team Lead. Operations Team Lead will be responsible for people management of these direct reports including development, coaching, appraisals and performance management.
Reporting to the Manufacturing Manager of the functional area, the primary role of the Operations Team Lead is to manage the daily manufacturing operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met.
Operations team lead will lead the team through successful product launch activities, process validation and regulatory inspections.
It is expected the Operations Team Lead will develop a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant manufacture of Drug Substance material. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.
Main areas of responsibility:
- People management of direct reports of biotechnicians and shift leads
- Lead and support the MFG team in the manufacture of drug substance material under cGMP conditions.
- Ensure schedule adherence, assist in MFG troubleshooting and facilitate appropriate escalation.
- Support and partner closely with the MFG Managers, Operations Team Leads, shift leads and biotechnicians and other colleagues
- Ensure training, master batch records, SOPs and other documents are current and compliant under cGMP conditions – ensure training, manufacturing systems and practices are consistent throughout the organization.
- Lead and support daily operation of processing systems and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration.
- Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
- Represent MFG group as necessary at critical meetings.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Coach, mentor and train shift leads and biotechnicians on MFG processes, use of operational excellence tools, and high performance team behaviors.
- Participate and support plant optimization that helps create a strong value proposition for future investment.
Strong focus of visibility boards for MFG metrics and status with particular focus on release cycle times.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience in a GMP environment is preferred.
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
- Demonstrated experience working with MFG processes in production including hands on experience in either:
- Cell culture bioreactor, seed lab and harvest operations or
- Chromatography, ultra-filtration, and other purification unit operations or
- Support services unit operations; media/buffer preparation, autoclave and parts washer
- Past experience and demonstrated ability to successfully influence team performance in a high performance team is strongly preferred.
- Track record of embedding a strong Quality culture. Trackwise experience preferred.
- Demonstrate strong communication skills and the ability to interact across cross-functional teams.
- Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections and direct interaction with regulatory inspectors.
- Highly developed organizational and leadership skills.
- Process development and/or technology transfer experience preferred.
CONTACTSList the key positions, internal and external, with which the job incumbent must interact.
Work closely with Process Development, Manufacturing Science and Technology Group, Quality Operations, Facility Services and Production personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
SUPERVISOR RESPONSIBILITYList the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
The Operations Team Lead of a given functional area will typically have ~8-15 direct reports; biotechnicians and shift leads. The Operations Team Lead will be responsible for a group of ~8-15 staff including a full rotating 24 hour and weekend shift operations. The role may require the successful candidate to work shift operations that align with the business needs.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.