Head of Sterile Manufacturing

Head of Sterile Manufacturing

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

Based in the Manufacturing Operations team, the post holder is responsible for all Sterile GMP manufacturing operations, including process development, Clinical batch manufacture, technical transfer activities and process scale up. The post holder will be responsible for the operational activities within the Unit 7 manufacturing facility and equipment for which these operations are conducted.The role will have direct line management responsibility for operational staff within this functional area.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 the management of third-party suppliers for critical Sterile consumables and services.

Main duties and responsibilities:

Ensure that all manufacturing operations within the Sterile GMP facility are fully compliant with the regulatory requirements set out in EU GMP Annex 1: Manufacture of Sterile Medicinal products.

Ensure that all manufacturing operations within the Sterile GMP facility are fully compliant with the Upperton Quality System

Facilitate the development and qualification of all processes and systems relevant to Sterile operations within Upperton.

Lead facility tours for client visits / audits and regulatory inspections.

Responsible for implementation of the Upperton Quality system in the 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 Sterile GMP manufacturing team and be responsible for their performance, training and regular appraisal

Responsible for the Sterile GMP facility (including environmental controls), equipment and all process qualification / validation / simulation.

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 with the Director of Clinical Manufacturing.

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 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 sterile manufacturing environment

Intimate knowledge of the regulatory requirements set out in EU GMP Annex 1: Manufacture of Sterile Medicinal products.

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!
• Annual bonus based on company and individual performance
• 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.