Packaging Operations – Team Lead

Packaging Operations Team Lead - 12 Month Assignment

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.

All Packaging Technicians and Shift Leads from respective shifts will report to the Packaging Operations Team Lead. Packaging Operations Team Lead will be responsible for people management of these direct reports including development, coaching, appraisals and performance management.

Reporting to the Packaging Operations Manager, the primary role of the Packaging Operations Team Lead is to manage the daily packaging operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met. Packaging Operations Team Lead will lead the team through successful product launch activities, process validation and regulatory inspections.

It is expected the Packaging 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 packaging of Finished goods. 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 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

Degree in science/engineering, operations management or industrial engineering or equivalent experience in a GMP environment is preferred.

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.

Work closely with QA Operations, Packaging Development, Engineering, Material Operations & Packaging technicians & BPS's to support escalation resolution and implement effective CAPA's.

The Packaging Operations Team Lead of a given functional area will typically have ~8-15 direct reports; Packaging technicians and shift leads. The Packaging Operations Team Lead will be responsible for a group of ~8-15 staff including a full rotating 2 shift Operations shift pattern. (Early & lates Monday to Friday). 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. 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.