Head of Sterile Manufacturing Operations Director
6 days ago
The Head of Sterile Manufacturing is responsible for overseeing the daily operations of our Sterile GMP manufacturing facility. This includes managing a team of professionals to ensure compliance with regulatory requirements, development and qualification of processes and systems, and facilitation of client visits and audits.
About Us
Upperton Limited is a leading CDMO providing a comprehensive service from early-stage feasibility to GMP clinical manufacture. Our state-of-the-art facilities in Nottingham offer a range of delivery routes, including oral, nasal, and inhaled formulations.
Responsibilities
The successful candidate will have experience of developing and leading a manufacturing function within a sterile environment. Key responsibilities include ensuring all operations are fully compliant with EU GMP Annex 1: Manufacture of Sterile Medicinal products, facilitating process development and qualification, and managing 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.
- Facilitate the development and qualification of all processes and systems relevant to Sterile operations within Upperton Limited.
- Lead facility tours for client visits / audits and regulatory inspections.
Requirements
The ideal candidate will have a degree-level education in a relevant science/engineering/manufacturing discipline, intimate knowledge of EU GMP Annex 1: Manufacture of Sterile Medicinal products, and experience of operating and influencing at a strategic level. They will also be able to add value, reduce costs, and make business improvements.
What We Offer
We offer a competitive salary of £80,000-£100,000 per annum, dependent on experience, as well as an excellent suite of benefits including 33 days holiday (inclusive of public holidays), 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, and employee events throughout the year.
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