Manufacturing and Production Director
1 month ago
Our client, a leading biotechnology company based in Cambridge, is seeking an experienced Director of Manufacturing to oversee the expansion of their gene therapy portfolio and GMP platform.
The Opportunity
This is a senior role for a highly experienced individual with a proven track record of driving biological manufacturing portfolios and overseeing technology transfer programmes.
Key Responsibilities
- Continuing the expansion and development of manufacturing processes and frameworks.
- Leading and overseeing technology transfer from research and development and manufacturing science and technology teams.
- Overseeing process validation activities within the manufacturing team.
- Providing leadership to the manufacturing and quality assurance teams.
- Growing and motivating the manufacturing team to support overall business goals.
- Overseeing manufacturing facility maintenance and ensuring GMP compliance.
- Liaising with external partners and customers for complex projects relating to synthetic DNA and IND submissions.
Requirements
- BSc / MSc / PhD in Biology (or equivalent biological degree).
- A minimum of 5 years' experience working within a biological manufacturing setting with GMP or GCP accreditation.
- Excellent leadership skills and experience.
- Proven expertise in leading manufacturing process development activities including scale-up, regulatory submissions, and analytical characterisation.
- Proven experience in managing large and complex projects within the biological sector.
- Extensive knowledge of GMP / GCP / GLP / CMC guidelines.
- Strong business acumen.
- Great attention to detail.
- Great organisational and planning skills.
The Package
Our client offers a competitive salary, progression options, and a benefits package including private pension and private health insurance.
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