SRG are working with KalVista, an innovative and rapidly growing pharma discovery company working on small molecule drug candidates for HAE (hereditary angiodema) and DME...
SRG are working with KalVista, an innovative and rapidly growing pharma discovery company working on small molecule drug candidates for HAE (hereditary angiodema) and DME (diabetic macular angiodema). Owing to expansion they are looking to make a key hire- a Drug Substance Manager to manage External Contract Manufacturing Organisations.
Our client are a specialist pharma company, listed on the NASDAQ with a strong development pipeline. Due to continued growth they are looking to hire a Drug Substance Manager to lead the progression of key assets from the end of phase I through to commercialisation. In a key role reporting to the Director of Chemistry, you will be company expert in all aspects of the synthetic chemistry process development and manufacture of small molecule targets and manage their delivery.
Specific Responsibilities will include:
- Provision of CMC technical and regulatory support for API manufacture from the end of Phase I through to NDA/MAA and commercial supply
- Management of Contract Manufacturing Organisations (CMO's) to ensure appropriate supply of drug product to meet project objectives
- Contribute to planning, data review and writing of regulatory submissions, primarily to the FDA and EU
- Close involvement with both internal and external GMP audits
To be considered you will need the following skills and experience:
- Qualified Chemist- Ideally PhD level but of course industry experience will be taken in to account
- Demonstrated experience of successful delivery of late phase API manufacture from Phase I through to commercial
- Several years' experience working in the chemical development area of the pharma industry
- Established track record managing external CMO's
- Proven understanding of the data requirements and documentation needed for successful approval at clinical trial and NDA/MAA stage
- Thorough knowledge and experience of GMP
- Strong scientific mind set and problem-solving skills
- Excellent communication skills
- Team player with strong influencing skills and an ability to collaborate effectively cross functionally
In return the company will offer the successful candidate a collaborative, flexible and dynamic work place and competitive package
Key Words: Pharmaceuticals, Drug Discovery, R&D, Contract Manufacturer, CMO, CMC, Outsourcing, Quality, Clinical Trials, PhD, Organic Synthesis, Pharma
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.