Job Description

We are establishing a state-of-the-art

pharmaceutical manufacturing facility in the UK

focused on the production of

Specials (Unlicensed Medicines)

. We are seeking an experienced and visionary leader to

build and lead this facility from the ground up

.

This is a

unique opportunity

to shape a new operation, drive regulatory approvals, and play a pivotal role in providing vital medicines to patients with unmet needs.

Role Purpose

This role is responsible for leading the end-to-end setup of a pharmaceutical manufacturing facility in the UK specialising in the manufacture of

Specials (Unlicensed Medicines)

. The individual will oversee facility design, regulatory approvals, MHRA licensing, quality systems implementation, and operational readiness. Once operational, they will act as the senior leader ensuring compliance, efficiency, and sustainable growth of the site.

Key Responsibilities

Facility Setup & Compliance Lead the design, layout, and commissioning of a Specials manufacturing unit in compliance with MHRA and EU GMP requirements. Ensure cleanroom classifications, equipment, and utilities are fit-for-purpose for Specials manufacturing. Liaise with architects, contractors, and equipment suppliers to ensure facility readiness.

Regulatory & Licensing

Obtain all necessary MHRA approvals, Manufacturer's "Specials" (MS) Licence, and other relevant permits. Develop, implement, and maintain GMP-compliant Quality Management Systems. Serve as the point of contact for inspections and audits.

Operations & Management

Recruit, train, and lead a multidisciplinary team (production, QC, QA, regulatory). Implement systems for batch release, quality assurance, pharmacovigilance, and documentation. Ensure robust supply chain processes for raw materials and distribution of Specials.

Strategic Contribution

Provide technical expertise on Specials formulation and manufacturing. Develop business continuity strategies, risk management, and growth plans. Ensure cost-effective operations while maintaining the highest standards of patient safety.

Qualifications & Experience

Degree in Pharmacy, Pharmaceutical Sciences, or related field (MSc/PhD desirable). Eligible to be named on the Manufacturer's "Specials" Licence (e.g., Qualified Person (QP) status is highly advantageous). Minimum 5

+ years' experience

in pharmaceutical manufacturing, with at least 3

years in Specials or aseptic manufacturing

. Proven track record in setting up or leading pharmaceutical facilities. In-depth knowledge of

MHRA regulations, GMP, GDP, and Specials framework

in the UK. Strong leadership, project management, and regulatory liaison skills.

Key Competencies

Regulatory expertise and audit readiness. Strategic leadership and operational execution. Excellent communication with regulators, stakeholders, and internal teams. Entrepreneurial mindset to build and grow a new facility.
Job Type: Full-time

Pay: 50,000.00-55,000.00 per year

Benefits:

Company pension On-site parking
Work Location: In person