Packaging Operations – Team Lead
Description
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
Packaging Operations Team Lead will lead the team through successful product launch activities, process validation and regulatory inspections.
- People management of direct reports of packaging technicians and shift
- Lead and support the packaging team to ensure delivery of the production schedule.
- Assist in troubleshooting and facilitate appropriate
- Support and partner closely with the Packaging BPS, Warehouse, Quality (QA & QC), Engineering and other colleagues.
- Represent the Packaging group as necessary at critical meetings (e.g. Daily Ops meeting, S&OE, Functional Lead Team meeting etc.)
- Responsible for reporting out on key performance indicators (e.g. Schedule adherence, Changeover performance, Unplanned downtime etc.)
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Responsible for ensuring training records and training plans are in place and up to date for all team members.
- Ensure training, master batch records, SOPs and other documents are current and compliant under cGMP.
- 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.
- Coach, mentor and train shift leads and packaging technicians on packaging processes, use of operational excellence tools, and high-performance team behaviors.
- Assist in preparation of performance evaluations and coaching of staff.
- Assist in the recruitment and hiring process for the Packaging operations team.
- Participate and support plant optimization that helps create a strong value proposition for future investment. (Including input into current capital projects)
- Required to worked closely with the Packaging project lead to support the delivery of the Packaging strategic master plan.
- Strong focus of visibility boards for packaging metrics and status with particular focus on schedule adherence & changeover performance
- 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.
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.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.