Are you a Manufacturing Manager looking for your next opportunity? If so, an opportunity has just become available to work for a globally established Biotechnology company based in Edinburgh. We have a fantastic opportunity available for a Manufacturing Manager to join a world-leading contract manufacturing and development organisation, specialising in the field of cellular therapies, advanced therapeutic medicinal products, and regenerative medicine. This company focuses on proving manufacturing services for companies developing cell based therapeutic products. They operate a fully licensed GMP manufacturing facility, and they possess a proven track record in the delivery of cell-based products.
Reporting to the Head of Manufacturing Operations, the Manufacturing Manager will have direct line management responsibility for multiple teams spread across different manufacturing sites. The Manufacturing Manager will be responsible for leading and motivating manufacturing teams, ensuring safe and smooth execution of the manufacturing master production schedule. As a key member of the management team, the ideal candidate will demonstrate excellent staff management skills combined with the ability to forward plan, assimilate technical knowledge, and drive a Quality/improvement/right first-time mindset.
This position would be an ideal opportunity for someone with prior experience of Biopharmaceutical manufacturing to develop their career in a new and exciting scientific arena. Candidates with previous cGMP cell and gene therapy, mammalian cell culture, sterile manufacturing and/or commercial manufacturing experience would be a good fit for this role.
On offer is a competitive salary and benefits package which can be disclosed over the phone.
Responsibilities include:
As a key member of the management team in a fast-paced organisation the responsibilities will be varied, but will include:
- Working closely with the Manufacturing Section Managers, Lead Biotechnologists and their teams to manage a wide range of manufacturing activities through preparation, scheduling, resource planning, pre-campaign briefing, execution and batch record review to ensure batches are manufactured correctly and released on time, in accordance with the manufacturing master production schedule and customer expectations.
- Championing of a culture of high performance, focus, low error rate and consistent clean room behaviours with an 'on the ground' approach.
- Driving improvements to company processes, quality and right first time.
- Monitoring of resources and training status to ensure they are aligned to the individual, process and commercial demand.
- Ensure that all team colleagues have development goals which are aligned to corporate objectives.
- Providing appropriate coaching, mentoring and performance feedback.
- Providing input to the talent, promotion and salary review processes.
- Pro-active management of inadequate performance following company guidance and policies.
- Ensuring compliance with H&S standards (company policies, rules and regulations).
- Completion, review and approval of quality related documentation including change controls, incidents/deviations and risk assessments in accordance with cGMP and standard operating procedures relating to the role.
- Leading problem solving and root cause analysis sessions as necessary, providing transparent and open communication both to Senior/Executive Management and clients.
- Alongside the Project Managers and the wider team, ensure timely, transparent and concise communication on manufacturing activities.
- Working collaboratively with the Development team and/or client to manage smooth technical transfer of new processes into Manufacturing.
- Ensure timely creation and/or review of GMP quality documentation including SOPs, batch records, incident/deviation reports, change controls and risk assessments.
Qualifications / skills required to be the successful candidate:
- The ideal candidate will hold a Life Science degree, or degree in a related subject, or equivalent relevant training and experience that includes cell culture. Green Belt certification with experience of Lean Six Sigma implementation would be desirable.
- Experience leading diverse, multi-functional teams.
- Experience of cGMP cell and gene therapy, mammalian cell culture, sterile manufacturing and/or commercial manufacturing.
- Excellent working knowledge of cGMP regulations (UK, European and US) particularly in respect of ATMPs, aseptic processing, contamination control, documentation and record management.
- Detailed understanding of the expectations associated with ATMP commercial manufacture.
- Experience of technology process transfer and a working knowledge of PICS and ISO regulations.