Packaging Operations Team Lead

PSC Biotech is hiring on behalf of our biopharmaceutical client a global leader in developing and delivering innovative therapies that make a meaningful difference for patients living with serious and life-threatening rare genetic diseases

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.

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
  

EDUCATION

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

EXPERIENCE

• 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 & BPSs to support escalation resolution and implement effective CAPAs.

SUPERVISOR RESPONSIBILITY

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.