Mantell Associates
Mantell Associates is currently partnered with a pioneering Pharmaceutical company focused on rare diseases. They are searching for a CMC Lead (API Development) to enhance their team.
CMC Lead (API Development) – Responsibilities:
- Support API process development and manufacturing activities
- Provide your technical expertise to troubleshoot manufacturing issues
- Independently design organic synthesis strategy, purification, scale-up and characterization
- Oversight of applicable outsource CMC development activities
- Interpret data to form sound conclusions and design experimental troubleshooting if needed
- Demonstrate creativity, problem-solving and critical thinking skills to overcome potential challenges all while building/strengthening IP
- Collaborate with scientific colleagues across functional disciplines and departments
- Contribute to drafting regulatory filing documentation and patent applications
CMC Lead (API Development) – Requirements:
- Ph.D. in organic chemistry with minimum 3 years industry experience
- Background in modern synthetic and physical organic chemistry with experience designing and executing multistep synthesis of complex organic molecules
- Awareness of latest scientific literature
- Experience in due diligence with CROs beneficial
- Background with IMPD preparation beneficial
- Good interpersonal, organizational and communication skills
- Demonstrated ability to work well in interdisciplinary team
- The ability to manage outsourced projects with external vendors
- Expertise in advanced data analytics, data science, mathematical modelling is an advantage
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.