GMP Manufacturing Operations Director
|Job Title:||GMP Manufacturing Operations Director|
|Salary:||Generous salary plus bonus and shares|
|Contact Name:||Alex Butcher|
|Job Published:||December 05, 2019 11:21|
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.
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