Drug Substance ManagerWiltshireSRG are currently working with an innovative and rapidly growing pharmaceutical discovery and development company based in Salisbury. Owing to expansion, our client...
Drug Substance Manager
SRG are currently working with an innovative and rapidly growing pharmaceutical discovery and development company based in Salisbury. Owing to expansion, our client is looking to make a key hire - a Drug Substance Manager to manage their external Contract Manufacturing Organisations.
My client is a specialist pharmaceutical company, listed on the NASDAQ, with a strong development pipeline. Due to continued growth they are looking to hire an additional Drug Substance Manager to lead the progression of key assets from the end of phase I through to NDA/MAA and commercialisation. In a key role reporting to the Director of Chemistry, you will act as company expert in all aspects of the synthetic chemistry process development and manufacture of small molecule targets and manage their delivery to meet company objectives and regulatory requirements.
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
- Project management of API 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 cGMP audits
To be considered you will need the following skills and experience:
- Chemistry qualifications - preferably the study of organic synthesis to PhD level
- Demonstrated experience of successful delivery of late phase API manufacture from Phase I through to commercial
- Three years' experience working within the chemical development area of the pharmaceutical industry
- Established track record managing API CMO's
- Proven understanding of the data requirements and documentation needed for successful regulatory approval at clinical trial and NDA/MAA stage
- Thorough knowledge and experience of GMP
- A good planner with the ability to find creative ways to meet aggressive timelines
- Strong scientific mind set and problem-solving skills
- Excellent communication skills, both written and presentation
- Team player possessing strong influencing skills and an ability to collaborate effectively across functions, organisational boundaries and cultures.
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, Cntract Manufacturer, CMO, CMC, Quality, Clinical Trials
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.