Director, Chemical Development
- England, England
- Pharma & Biotech
I am currently working with a small Pharmaceutical company who are looking for a home-based Director of Chemical Development to join the team.
As Director of Chemical Development, your main purpose will be to provide leadership and direction for Chemistry, Manufacturing, and Controls (CMC) activities from pre-clinical activities though early stage clinical programs.
- Determine requirements for specific CMC activities needed to support programs and translate these requirements into requests for proposals
- Develop request for proposals describing detailed work and timeline requirements for submission to selected vendors; evaluate proposals and negotiate revisions; provide recommendation for vendor selection with clear rationale and justification for selection
- Manage contract resources required to support drug substance synthesis for pre-clinical activities and early clinical development. Ensure project deliverables are provided on time and within budget
- Provide scientific expertise to support Corcept's manufacturing group
- Manage drug substance logistics to ensure sufficient materials are available to support planned pre-clinical and early phase clinical studies
- Solve problems related to API synthesis and other drug substance challenges
- Provide CMC representation to appropriate project teams
- Draft CMC sections of regulatory submissions
- Contribute to budgeting and accounting processes
- PhD in organic chemistry
- 5-10 years minimum experience in a variety of drug development programs
- Detailed knowledge of the drug development process and cGMP
- Detailed knowledge of ICH Q7 guidance, FDA and EU regulatory guidance for CMC
- Detailed knowledge of manufacturing and analytical technologies required for manufacturing drug product and drug substance
- Excellent leadership, problem solving, communication and negotiation skills
If you are interested in this role, or want to hear more about it, please get in touch as soon as possible - the process has begun!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales