Drug Product 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.

Drug Product Operations Team Lead is a role based in new Drug Product facility at Shanbally.

All drug product technicians and shift leads from respective shifts will report to the Drug Product Operations Team Lead. Drug Product Operations Team Lead will be responsible for people management of these direct reports including development, coaching, appraisals, and performance management.

Reporting to the Drug Product Operations Manager, the primary role of the Drug Product Operations Team Lead is to manage the daily operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met.

Drug Product Operations team lead will lead the team through successful startup activities, process validation and regulatory inspections. 

It is expected the Drug Product 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 filling of Drug Product. 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 technicians and shift leads
• Lead and support the team to ensure delivery of the production schedule
• Assist in troubleshooting and facilitate appropriate escalation
• Support and partner closely with the BPS, Warehouse, Quality (QA & QC), Engineering and other colleagues
• Represent the Drug Product 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, line throughput, 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 technicians on 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 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 Operations Manager & Engineering to support the delivery of the Drug Product strategic master plan
• Strong focus of visibility boards for production metrics and status with particular focus on schedule adherence & line throughput

EDUCATION

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

EXPERIENCE

• Demonstrated experience working with GMP Mfg processes
• 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 result
• Experience with regulatory inspections and direct interaction with regulatory inspectors
• Highly developed organizational and leadership skills
• Process development and/or technology transfer experience preferred

CONTACTS

Work closely with QA Operations, GMSAT & MSAT CoE, Engineering , Material Operations & technicians & BPS’s to support escalation resolution and implement effective CAPA’s.

SUPERVISOR RESPONSIBILITY

The Operations Team Lead of a given functional area will typically have ~8-15 direct reports; technicians and shift leads.

The 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.

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.