TEC Partners are currently recruiting for a Head of CMC to join a world class research team in a dynamic, rapidly expanding Cambridge-based Biotech. The company is actively working on an exciting portfolio of projects, have exciting collaborations in place, with an expanding small molecule drug discovery portfolio. They currently have two programmes in early phases of clinical development.

Head of CMC role:

The Head of CMC (Development and Manufacturing) will be responsible for providing strategic leadership and ultimate accountability for all drug substance and drug product development activities. They will be responsible for CMC development, manufacturing (both GMP and non-GMP) and supply chain activities of all drug substance and drug product for clinical and eventually commercial supply.

Development work and all GMP manufacturing is done externally, the Head of CMC will be responsible for appropriate in-house CMC expertise. They shall be familiar with typical risks and bottlenecks associated with CMC development and external manufacturing, but also be able to solve complex challenges and ultimately assure reliable, on-time supply of clinical trial material.

Responsibilities and duties:

The Head of CMC will be responsible for:

Providing operational and strategic oversight and leadership for all starting materials, drug substance, and drug product development, non-GMP and GMP manufacturing activities for all programs (from preclinical through commercialisation)
Planning, aligning and establishing a small, CMC team of in-house staff and external consultants, and overseeing the hiring, training, and management of all in-house functions such as Quality (CMC), Regulatory CMC, Clinical Supply Chain Management, Analytical Development, and Process Development (DS + DP)
Overseeing management of existing CDMO/CMOs and selection of future CDMO/CMOs, analytical labs, or other suppliers
Holding partner CDMO/CMOs accountable for meeting desired specifications, adhering to timelines and budget, and complying with regulatory requirements
Alignment of CMC Development with R&D and Clinical Development, planning and delivering all clinical supply
Establishing all manufacturing processes and analytical methods to the right level with appropriate tech transfer and establishment at CDMO/CMOs
Development of the Quality Management System (QMS) for the support of all CMC development work and required Quality oversight of all GLP and GMP activities relating to CMC
Establishing performance metrics, providing full transparency, regular updates of all CMC Development and GMP manufacturing work to Clinical Development, Management and Board Members as requiredQualifications and Experience:

Experience with small molecule API process development and manufacturing, formulation development, GMP manufacturing and supply chain. In addition, extensive experience in establishing and managing external, CDMO/CMO based CMC development and GMP manufacturing supply chains, as well as being well versed in the preparation of regulatory dossiers.

BSc or PhD in relevant Chemistry, Pharmaceutical Science, or Chemical Engineering
Significant pharmaceutical industrial experience in small molecule CMC Development and GMP manufacturing.
Experience of working with small molecules in an oncology setting would be an advantage.
Mixture of Biotech and Pharma experience would be desirable
Mixture of technical and managerial experience desirable; demonstrable management experience with excellent track record of managing multiple development projects required
Excellent leadership skills, demonstrated experience in leading virtual CMC Development and GMP manufacturing at CDMO/CMOs; demonstrable CDMO/CMO Management experience required
Proven track record of establishing and leading diverse technical teams to high performance results in CMC Development, Technical Operations, Pharmaceutical Sciences, or Pharmaceutical Development
Proven track record of strategic thinking and establishing and executing technical strategies
Current and broad knowledge of regulatory requirements for UK, Europe and US for small molecule development and GMP manufacturing
Previous experience with interfacing with Health Authorities for scientific advice, pre-submission meetings and inspections
Previous experience with development and oversight of Regulatory Submissions such as INDs, IMPDs, NDAs, and MAA
Excellent communication, team working, and excellent presentation skills when explaining impact of technical matters to executives in other disciplines
Excellent reputation and extended external network in the Biopharma peer community

This is a full-time, permanent position, offering an attractive salary & benefits package. If you have the right background and want a fresh challenge in an exciting Biotech, then please apply right away with an updated CV