Laboratory Manufacturing Manager
Kelly Services, working on behalf of our International Biosciences company, are actively recruiting a Laboratory Manufacturing Manager to join their team on a permanent basis at their site in Edinburgh.
As Laboratory Manufacturing Manager, you will be mainly laboratory based and you will take on the responsibility for the leading and motivating their direct reports to ensure safe, cost efficient and smooth execution of the manufacturing master production schedule. You will be a key member of the Operations team which will require you demonstrating excellent staff management skills combined with the ability to forward plan, assimilate scientific / technical knowledge and drive a Quality/ Continuous Improvement/Right First-time culture.
· Managing direct reports to ensure a wide range of manufacturing functional cells and stem cells from Ispc cells and associated media products through preparation, scheduling, resource planning, 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.
· Ensuring that the department is working to current ISO 9001 (2015) standards, in terms of SOP's, manufacturing batch records and any required traceability, taking responsibility for all Quality Documentation relating to technical transfer and manufacturing of products and services using Q -Pulse QMS.
· Generating KPI's for the manufacturing department to measure performance and aid continuous improvement ethos.
· Be able to develop and implement standard operating procedures (SOPs) to ensure consistent and compliant application of policies and programs throughout the laboratory.
· Lead problem solving and root cause analysis sessions, as necessary.
· Organise and delegate general lab/manufacturing duties (e.g., production, inventory of supplies, waste disposal, safety measures)
· Training of current and new staff - maintaining departmental training matrix.
· Provide mentoring and coaching to staff and being proactive towards inadequate performance following company polices and appraisal system.
· Ensure compliance with Health & Safety standards (company policies, rules and regulations)
· Providing technical support to clients /customers if required
· Inventory Management, including planning and purchasing of materials/ laboratory supplies to maintain constant production within budget and in specified timeframes working with Supply chain / Inventory colleagues.
· Ensure safe, cost efficient and smooth execution of the manufacturing master production schedule.
· Ensure that new products are correctly technically transferred from R & D to Operations ➢ Maintain and improve both product processes and Quality Management System.
· Mentor, train and measure performance of the manufacturing team against team and individual goals and targets
· Required knowledge, skills, and abilities
The successful candidate will have the following experience, skills, and attributes:
· The candidate will have excellent verbal and written communication skills. English as a native language (preferred)
· Self-motivated, organised with excellent independent troubleshooting ability.
· Have a working knowledge of ISO 9001 and / or ISO 13485 Quality Management systems
· Prior experience with gene editing or hPSC differentiation technologies would be desirable.
· Additionally, the candidate should be efficient, proficient, and extremely well-organised (excellent time management is imperative) as well as comfortable working in a fast-paced team environment.
· Excellent communicator who takes a dynamic and pro-active approach to finding effective ways to achieve deliverables.
· Proven team player, able to establish a shared vision and work.
· Determination to succeed with a 'can do' attitude.
· Passion for Customer Satisfaction
· Honesty & integrity
· Ownership /accountability of role, projects, tasks
· Sound work ethics
· Ability to work under pressure delivering results.
· Emotional resilience and an ability to work under pressure with good humour.
· Ability to create a positive environment through self-awareness and social skills
The successful candidate will hold a postgraduate degree in molecular or cell biology (PhD level) and have significant expertise in mammalian cell culture. Be a highly motivated and experienced cell culture specialist supporting the generation and quality testing, inventory of our current products and the development of future products and have a minimum of 5 years' experience working in ISO or cGMP commercial laboratories.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.