30+ days ago
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 Production Manager will work alongside Technical Transfer, QA, and Validation for facility start up through cGMP commercial launch to going production. The Manager will be responsible for developing, managing and leading the team 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:
To lead, manage and develop operators using appraisal, communication and HR systems. Ensure pharmaceutical awareness and operating standards within the team as well as job skills and knowledge.
Deputise for BU Leader
Support associated areas when the business requires
Issue resolution plans utilising Production, Quality and Maintenance resource allocated to the production area with no impact to the schedule.
Track and monitor downtime in the area, implement strategies to reduce downtime
Allocation of labour allocation (suitably qualified and experienced) and organisation (to ensure continuous line running where appropriate).
GMP/ Compliance and Ethical Conduct
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
Deliver a timely closure of BMRs 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
Completion of Level 1 & 2 audits.
Maintain a high level of tidiness and cleanliness at all times – personal, personnel, work area and department.
Ensure aseptic licences, as required, are kept up to date for all personnel involved in sterile manufacturing.
Lean & Change Management
Ensure all 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.
Agree measures of performance and targets with Production Manager, communicate to the teams through the daily communication processes (handovers, huddles and VMBs) to achieve targets.
Monitor and report team performance to targets using VMBs Tools.
Responsible for initiating, developing and implementing strategic development programs relating to improvements and advancement in manufacture, filling, inspection and packing.
Support the implementation of continuous improvement programmes.
Support the introduction of new products, equipment and processes.
Safety, Health & Environment
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.
Who are we looking for:
Significant experience of manufacturing sterile drug products to EU and US standards.
Proven 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 bulk powder manufacturing and filling experience.
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.
Aptitude for or working knowledge of mechanical and software operations desirable.
Demonstrable ability to make sound risk-based decisions in line with internal and external quality standards.
Strong experience in lean manufacturing techniques.
What’s in it for you:
Competitive base salary
Free on-site car parking
Private medical insurance
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 unrivaled 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, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com