Director of Scientific Operations
Director of Operations
Contract: Full-time and permanent (Monday to Friday)
Salary: Generous base salary, with benefits, bonus and share options.
Reporting to: C-suite
Our client is an innovative biotechnology company based outside of the centre of Cambridge. They are experts in gene synthesis, with a novel enzymatic method to ensure cheaper, faster and more accurate DNA / RNA constructs than traditional plasmid-based methods. In a key phase of their development, our client is looking for an experienced Director of Operations to oversee their planned expansion of their manufacturing and commercial operations. This represents a great opportunity for an individual to make a large impact on an innovate area of biotechnology.
As their Director of Operations, you will be responsible for general oversight of the GMP DNA manufacturing operations, logistics + supply chain, facilities management, ESG and EHS.
This is a senior opportunity for a highly experienced individual who has a proven record of leading operations within a biological/pharmaceutical GMP environment. As their Director of Operations, you will be responsible for:
- The ownership and expansion of an operations team for a GMP grade DNA manufacturing facility.
- Overseeing all facility maintenance and compliance (GMP / GDP etc) across multiple sites
- Overseeing compliance and ensuring Health and Safety (EHS) and ESG requirements are met across multiple sites
- Act as a source of motivation for teams and getting involved in the expansion of the team where appropriate.
- Monitor operational performance through reports and collection of data for key metrics.
- Cross-communication with all other departments within the business, including R&D, MSAT, regulatory and quality.
- Leading projects to improve business / operational processes.
Skills and Experience Needed
The ideal candidate will have the following:
- Extensive experience of managing operations of a pharmaceutical / biological manufacturing setting (essential)
- Experience of managing operations within a CDMO environment (desirable)
- Previous experience managing cleanroom facilities (Grade A-D / ISO 5,6,7,8) (essential)
- Strong cGMP understanding and experience working in a GMP accredited facility (essential)
- Oversight and management of operational budgets (essential)
- Understanding of the regulatory requirements for pharmaceutical products according to MHRA, EMA or FDA. (essential)
- Leading and completion of operational related projects (essential)
- Prior leadership / team leadership experience within a biotech or pharmaceutical setting (essential)
- Experience in auditing and regulatory inspection (essential)
- Expertise in GMP grade quality management systems (QMS) and processes like change control, equipment validation + commissionsing, qualification etc (essential)
- Lean Six Sigma experience (desired)
As an up-and-coming Cambridge Biotech, our client is able to offer a competitive salary and benefits package including private pension 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.