Senior Director

4 weeks ago

United Kingdom taylorollinson Ltd Full time

Industry Sector Biotechnology , Chemical , Medical Devices , Pharmaceutical , Other Profession Laboratory Operations & Research , QA & Regulatory Location UK , East Anglia Salary Competitive Base + bonus + share options Description
Contract: Full-time and permanent (Monday to Friday) (Part-time and hybrid working will be considered on a case by case basis)
Biotechnology
Generous base salary, with benefits, bonus and share options.
Our client is an innovative biotechnology company based outside of the centre of Cambridge. Their technology provides exciting possibilities for ensuring cheaper, faster and more accurate DNA / gene constructs than traditional plasmid-based methods. In a key phase of their development, our client is looking for an experienced Director of Manufacturing to oversee their planned expansion of this side of this business. This represents a great opportunity for an individual to make a large impact on meaningful life-sciences projects.
This is a senior opportunity for a highly experienced individual who has a proven record of leading CMC biologicals programmes and support of technology transfer activities. Continuing the expansion and development of manufacturing processes and frameworks across the GMP cleanroom facilities for DNA production.
Supporting technology transfer projects from the research and development teams. Spearhead departmental improvements as the facilities grows. You will do this through the evaluation of existing processes and improving areas such as costs, quality, time etc.
Act as a point of contact for external regulatory body communications, audits, regulatory submissions etc.
Build and oversee cross-departmental relationships with R&D, quality, regulatory teams etc.
Lead the daily organisational activities of the GMP team and take responsibility for staff training.
Act as a point of contact for external clients with respect to project updates and regulatory plans.
Manage troubleshooting and problem-solving projects, liaising with Quality to ensure CAPAs are in place and completed.
BSc / MSc / PhD in Biology (or equivalent biological degree) (desired)
Expertise within internal technology transfer of R&D projects to manufacturing including scale-up, process optimisation and stability testing (essential)
Understanding of quality assurance processes for biologicals manufacture (process validation, CAPAs etc) (essential)
As an up-and-coming Cambridge Biotech, our client is able to offer a competitive salary, progression options and benefits package including bonus, stock options and private health insurance.
Compulsory fields are in bold .
Name Email address Telephone Message Upload C.V. Process Validation Scientist Production Scientist (DNA) AAV Scientist Director of CMC (Biologicals) Director of Scientific Operations View all jobs #J-18808-Ljbffr

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