Head of Non-Sterile Manufacturing

2 days ago

Nottingham, United Kingdom Upperton Limited Full time

Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.

Continued growth and investment into the business has led to the creation of exciting new job opportunities; in our new GMP Manufacturing headquarters in Beeston, Nottingham. Upperton Pharma Solutions is undergoing a period of significant expansion to meet international customer demand and offer a comprehensive drug development portfolio, so now is a great time to join our team.

Our values ensure that will be joining a team with a truly positive and progressive culture surrounded by state-of-the-art facilities where you as a leader can share your ideas with other gifted and dedicated scientists and clients from around the world all focused on developing new medicines.

The Role

The Head of Non-Sterile Manufacturing is responsible for all GMP manufacturing operations within the Non Sterile Trent Gateway facility, including but not limited to, process development, scale up, clinical batch manufacture, technical transfer activities, warehouse and logistics. The post holder will be responsible for the operational activities within the Unit 3 manufacturing facility and equipment for which these operations are conducted. The role will have direct line management responsibility for operational staff within these functional areas. The post holder will ensure that all operations are developed and conducted within the framework of the Upperton Pharma Solutions Quality Management System and that the facility and operation is qualified to meet the regulatory requirements as set out by regulatory authorities. The post holder will also be responsible for building operational capabilities for commercial manufacturing.

Main duties and responsibilities:

  • Ensure that all manufacturing operations within the GMP facility are fully compliant with the Upperton Quality System and meet current regulatory requirements.
  • Facilitate the development and qualification of all processes and systems relevant to Non Sterile operations within Upperton.
  • Lead facility tours for client visits / audits and regulatory inspections.
  • Responsible for implementation of the Upperton Quality system in the Non Sterile GMP facility
  • Ensuring that all activities and outputs meet the Upperton quality system
  • Direct all scale up and production activities to ensure that project deliverables and targets are successfully met and are of the highest quality.
  • Manage and develop the Non Sterile GMP manufacturing and support teams and be responsible for their performance, training and regular appraisal
  • Responsible for the Non Sterile GMP facility (including environmental controls), adherence to equipment planned preventative maintenance, calibration and qualification and any requirements for process qualification / validation.
  • Ensure that all documentation emanating from the GMP facility meets the requirement of the Upperton Quality system including operating records, batch manufacturing records and project reports
  • Participate in customer contacts and business planning.
  • Track project activities from a commercial perspective. Ensure that commercial deliverables are tracked and fully met.
  • Liaise with Project Management and Finance to ensure that correct invoices are sent out on time
  • Provide critical support and focus on Non Sterile projects, focusing on Technical transfer and process scale up activities conducted both internally at Upperton and for projects outsourced to third party vendors.
  • Provide critical support and focus on Sterile projects, focusing on technical transfer and process scale up activities conducted both internally at Upperton and for projects outsourced to third party vendors.

Essential skills required:

  • Proven leadership and management skills with the ability to optimise team performance and development
  • Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders across internal departments
  • Excellent communication, interpersonal and influencing skills
  • Excellent analytical and problem solving abilities
  • Results orientated with ability to plan and deliver against project deadlines
  • Commercially and financially astute with experience of managing budgets
  • Resilient, self motivated and able to work well under pressure
  • Technical mindset
  • An appreciation of and an ability to positively resolve issues

Essential experience required:

  • Educated to degree level or equivalent in a relevant science / engineering /manufacturing discipline.
  • Demonstrable experience of developing and leading a manufacturing function with a proven track record within a pharmaceutical non sterile manufacturing environment.
  • Intimate knowledge of the regulatory requirements covering Investigational Medicinal Products. A knowledge of Commercial manufacturing is desirable.
  • Ability to add value, reduce costs and make business improvements
  • Experience of operating and influencing at a strategic level
  • Knowledge and technical understanding of sterile manufacturing processes.

What you will get in return

We offer employees not only a competitive salary but also an excellent suite of benefits including:

  • 33 days holiday (inclusive of public holidays) and your birthday off
  • Company contributory pension package
  • Life insurance
  • Private Medical Insurance through Vitality
  • Internal and external training courses and professional development support
  • Free onsite car parking

We know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fund raising events.

Apply.

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