Biopharma Manufacturing Team Lead

Fastnet The Talent Group

Cork

Exciting opportunity for an Operations Team Lead within Biopharma in Cork to lead a team of highly engaged Biotechnicians and Shift Leads. Permanent position, shift required. Reporting to the Manufacturing Manager of the functional area, the primary role of the Operations Team Lead is to manage the daily manufacturing operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met. Role will be based in either upstream cell culture, downstream purification or support services. Responsibilities: People management of direct reports of biotechnicians and shift leads- responsible for people management of these direct reports including development, coaching, appraisals and performance management. Lead the team through successful product launch activities, process validation and regulatory inspections. 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 manufacture of Drug Substance material. Lead and support the MFG team in the manufacture of drug substance material under cGMP conditions. Ensure schedule adherence, assist in MFG troubleshooting and facilitate appropriate escalation. Support and partner closely with the MFG Managers, Operations Team Leads, MPEG, shift leads and biotechnicians and other colleagues. Ensure training, master batch records, SOPs and other documents are current and compliant under cGMP conditions - ensure training, manufacturing systems and practices are consistent throughout the organization. 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. Represent MFG group as necessary at critical meetings. Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance. Coach, mentor and train shift leads and biotechnicians on MFG processes, use of operational excellence tools, and high performance team behaviors. Participate and support plant optimization that helps create a strong value proposition for future investment. Strong focus of visibility boards for MFG metrics and status with particular focus on release cycle times. Requirements: Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering. 3 years people management experience in a similar leadership role within a Pharma/Biopharma manufacturing environment. Demonstrated experience working with MFG processes in production including hands on experience in either: o Cell culture bioreactor, seed lab and harvest operations or. o Chromatography, ultra-filtration, and other purification unit operations or. o Support services unit operations; media/buffer preparation, autoclave and parts washer. 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. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2261 days ago