Director of CMC (Biologicals)
Director of CMC
Contract: Full-time and permanent (Monday to Friday) (Part-time and hybrid working will be considered on a case by case basis)
Salary: Generous base salary, with benefits, bonus and share options.
Reporting to: CEO
Our client is an innovative biotechnology company based outside of the centre of Cambridge. They specialise in the synthesis of GMP grade gene constructs utilising an enzymatic synthesis. 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. As a Director of Manufacturing, you will be responsible for:
- 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. This will include the review and submission of SOPs.
- 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.
- Create GMP documentation for manufacturing processes.
- Develop a process control strategy through establishing CPPs and CQAs in accordance with MHRA / EMA / FDA guidelines.
Skills and Experience Needed
The ideal candidate will have the following:
- BSc / MSc / PhD in Biology (or equivalent biological degree) (desired)
- Proven experience in developing manufacturing processes of biological products (therapeutics / drug substances / excipients) (essential)
- Expertise within internal technology transfer of R&D projects to manufacturing including scale-up, process optimisation and stability testing (essential)
- Prior experience working within a GMP environment and strong understanding of GMP documentation (essential)
- Understanding of quality assurance processes for biologicals manufacture (process validation, CAPAs etc) (essential)
- Extensive understanding of regulations from FDA / MHRA / EMA and common issues related to biologics (essential)
- A background that involves molecular biology (ideal/desired)
- Sterile injectables experience (desired)
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.
If you would like to apply to this opportunity, please send a copy of your CV to Charlie Cox at email@example.com – alternatively, please call Charlie on 07903 204577.