When you’re part of Thermo Fisher Scientific, you will do challenging work, and be part of a team that values performance, quality, and innovation. With revenues of $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
At our site in Swindon, Thermo Fisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs.
The Value Stream Lead ( internally this role is titled Business Unit Lead) will be responsible for delivering the operational activity fora fully serviced, highly customized cGMP facility with onsite client presence (a “Condo”). The BU Leader will work alongside all departments to ensure the Condo RFT, Quality and Delivery targets are met. The BU Leader will drive the department stakeholders to manufacture, fill, inspect and pack drug products, safely in line with the companies EHS regulations, in accordance to company quality regulations, and external regulatory compliance.
What you’ll do:
Leadership/ People Management:
- Optimize performance outcomes of the Condo by providing leadership and direction to the Condo team.
- Lead a matrix organization to ensure cross functional alignment and alignment on priorities for the Condo.
- Drive headcount planning for current and future Condo needs. Take a site wide view regarding capacity and flex resources accordingly
- Maintain an accurate Training Matrix and ensure Performance Management and Development Plans are in place for all team members, including both job technical knowledge and pharmaceutical knowledge development.
- Support the Production Manager and cover in their absence.
- Issue resolution plans utilising Production, Quality and Maintenance resource allocated to the production area with no impact to the schedule.
- Track and monitor operational metrics, including downtime, and implement strategies to reduce downtime
- Initiate and execute continuous improvement activities to improve cycle times, yields and compliance.
- Ensure compliance of self and others to internal and external regulations. Comply with all systems, processes, and procedures in line with statutory/ legislative/ quality requirements.
- Support and encourage a Quality Culture
- Deliver a timely closure of Batch Manufacturing Records as agreed with the department manager (including all MRP transactions).
- Investigate and lead process related deviations to ensure manufacturing, filling, and packaging activities are compliant with cGMP.
- Drive timely completion of DRs, CAPAs, and CCs as agreed with the department manager.
- Drive effective corrective and preventative actions for GMP incidents, troubleshooting situations.
- Identify staff training and development needs to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives.
- Ensure your area is audit ready at all times.
- Through a presence in the workplace, coach, and mentor staff to ensure products are manufactured and documentation completed in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.
- Timely completion of relevant deviation and complaint investigations to identify true root cause. Along with timely closure of corrective/preventative actions for deviations, complaints and GMP audits that are assigned to them with a focus on improved processes, documentation, documentation completion and training.
- To ensure work centre and designated areas housekeeping standards are maintained to ensure compliance with Current Good Manufacturing Practice (cGMP) and Health Safety & Environment regulatory requirements by utilizing 5S and lean initiatives
- Ensure aseptic licences, as required, are kept up to date for all personnel involved in sterile manufacturing.
- Ensure work is performed and delivered in accordance to approved and established processes and procedures and proactively look for opportunities to drive continuous improvement, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
- Responsible for initiating, developing, and implementing strategic development programmes relating to improvements and advancement in manufacture, filling, inspection, and packing.
- Support the implementation of continuous improvement programmes and the introduction of new products, equipment, and processes.
- Promote an environment of safety and wellbeing of self, others, and environment.
- Understand and ensure implementation of emergency procedures and safe systems of work.
- Ensure compliance with environment, health and safety rules, signage, and instructions at all times.
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
- Working alongside the EHS Manager and conduct scheduled audits
- Previous experience of manufacturing sterile drug products to EU and US standards.
- Strong leadership experience in a Pharmaceutical environment (Manufacturing, Packaging/ Quality, Engineering or equivalent).
- Experience of start-up facility activities desirable, good knowledge of facility validation requirements.
- Experience of medium to large scale pharmaceutical manufacturing, desirable powder manufacturing.
- Preferably qualified to degree level in Science, Business or Engineering or equivalents.
- Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.
- Experienced in managing and leading change, continuous improvements.
- Understanding of the end to end pharmaceutical manufacturing process essential.
- Demonstrable ability to make sound risk-based decisions in line with internal and external quality standards.
- Able to lead in matrix organisations
- Strong drive for results
- Strong experience in lean manufacturing techniques
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.