GMP Manufacturing Operations Director

GMP Manufacturing Operations Director

Job Title: GMP Manufacturing Operations Director
Contract Type: Permanent
Location: Guildford
Salary: Generous salary plus bonus and shares
Start Date: 2019-12-05
Reference: V-45973
Contact Name: Alex Butcher
Contact Email:
Job Published: December 05, 2019 11:21

Job Description

Due to ongoing expansion, a vacancy has been created for an Operations Director with a strong background in Pharmaceutical GMP manufacturing. We are looking for an innovative individual with a high level of management experience, a background in engaging with CMOs and the ability to think strategically about GMP operations within a precision production setting. You will join an exciting and innovative business who are a commercial stage drug development company headquartered in Surrey. Utilising a unique proprietary drug delivery platform, the company are developing a rich pipeline in prescription drug reformulation and gene therapy.

The Opportunity

You will be responsible for leading manufacturing operations, both in-house and by third party CMOs, ensuring cost-effective and quality GMP production of formulations and finished product.

The company has their own, separate, manufacturing facility in Surrey. This facility is set up for the scale-up and manufacture of intermediates for cosmetic skincare products and is currently being prepared for cGMP manufacture for clinical trials. In parallel, the company is trialing the production of its clinical trial intermediates by CMOs. The manufacture of finished products is outsourced to third parties.

The responsibilities of the Operations Director will include:
• Leading the manufacturing operations.
• Ensure the cost effective, timely, and quality controlled GMP production and distribution of intermediates and finished products
• Contract, audit, and manage third party CMOs and other subcontractors.
• Manage tech transfer and scale-up of formulations from R&D to manufacture
• Obtain and maintain IMP (MIA) certification for in-house production site
• Ensure regulatory compliance of both in-house and external manufacturing operations and interface with regulatory bodies, in collaboration with the Head of Quality and external consultants.
• Ensure the Company’s EH&S compliance

Key qualifications and skills:
• Degree level education or equivalent, preferably in life sciences.
• Several years’ experience in managing pharmaceutical manufacturing operations, ideally including time spent in entrepreneurial, investor-led smaller businesses.
• In-depth knowledge of GMP requirements, EH&S regulations, and other regulatory requirements.
• Demonstrable experience with managing third party CMOs.

This is a fantastic opportunity for an individual to directly impact a business and to join them at a pivotal time of growth.