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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 Senior 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.
Job 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
Requirements:
Degree in science/engineering, operations management or industrial engineering or equivalent experience in a GMP environment is preferred
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
Nice to have:
Process development and/or technology transfer experience preferred
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