Head of Manufacturing
North of England | Sterile Manufacturing | Aseptic Processing | Annex 1 | Pharmaceutical Operations
Allerton Bishop is retained to appoint a Head of Manufacturing for a highly regarded pharmaceutical organisation operating within a highly regulated sterile aseptic manufacturing environment.
This is a senior leadership appointment for an experienced pharmaceutical manufacturing professional to lead a critical GMP operation producing patient-essential products within cleanroom and controlled environments.
The successful candidate will take ownership of manufacturing performance, regulatory compliance, Annex 1 standards, people leadership, capacity planning, and continuous improvement across a strategically important operation.
The Opportunity
Reporting to senior leadership, responsibilities will include:
- Full leadership of sterile manufacturing and aseptic production operations
- Named Production Manager responsibility on MHRA manufacturing licence
- Ensuring compliance with EU GMP Annex 1 for manufacture of sterile medicinal products
- Oversight of contamination control strategy (CCS), cleanroom behaviours and environmental standards
- Media fills, aseptic process simulation and ongoing sterility assurance
- Production planning, scheduling, capacity and labour optimisation
- Batch documentation review and right-first-time manufacturing performance
- Validation, qualification and equipment readiness
- Deviations, investigations, CAPA and change control ownership
- Budget management, forecasting and cost efficiency programmes
- Leadership of MHRA, customer and regulatory inspections
- Development of high-performing manufacturing teams and succession plans
Candidate Profile
We are seeking an accomplished sterile manufacturing leader from one or more of the following sectors:
- Injectable manufacturing
- Aseptic fill finish
- Sterile compounding
- Ophthalmics
- Biopharmaceutical manufacturing
- Specials manufacturing
- Hospital manufacturing units
- CDMO sterile operations
You will likely bring:
- Significant leadership experience within aseptic or sterile GMP manufacturing
- Strong working knowledge of Annex 1 requirements and contamination control principles
- Proven experience leading cleanroom teams in Grade A/B/C/D environments
- Expertise in aseptic behaviours, gowning, EM trends, and sterility assurance
- Experience hosting MHRA / FDA / client inspections
- Strong understanding of validation, HVAC, utilities and manufacturing support systems
- Budget ownership and operational improvement experience
- Credible leadership style with strong coaching and accountability standards
Location
North of England
Relocation support will be considered.
Confidential Search
For a discreet discussion, please contact Andrew Davis at Allerton Bishop.
Keywords: Head of Manufacturing | Sterile Manufacturing | Aseptic Processing | Annex 1 | Head of Production | Manufacturing Director | Injectable Manufacturing | Fill Finish | Cleanroom Operations | Contamination Control Strategy | Sterility Assurance | MHRA | GMP | Pharmaceutical Manufacturing | Operations Director | North West | Yorkshire | North East | North of England