Packaging Operations Team Lead

About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.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 shiftLead and support the packaging team to ensure delivery of the production schedule.Assist in troubleshooting and facilitate appropriateSupport 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 complianceResponsible 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 performanceEDUCATIONDegree in science/engineering, operations management or industrial engineering or equivalent experience in a GMP environment is preferred.EXPERIENCEPast 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.SUPERVISOR RESPONSIBILITYThe 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.