FDC CMC Consultant

Barrington James; London; On-site; GBP 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a highly skilled FDC CMC Consultant to provide expertise in Chemistry, Manufacturing, and Controls for investigational new drug applications. This exciting role involves collaborating with cross-functional teams and external partners to ensure compliance with CMC requirements for regulatory approval. The ideal candidate will have a strong background in CMC development, a proven track record in strategy implementation, and excellent communication skills. Join this mission-driven organization and make a meaningful impact in drug development while contributing to a diverse and inclusive workplace.

Qualifications

• Extensive knowledge of CMC development and IND requirements.
• Proven track record in CMC strategy development and implementation.

Responsibilities

• Provide expertise in CMC for IND applications.
• Collaborate with teams to ensure CMC requirements are met.

Skills

CMC development

IND requirements

regulatory guidelines

communication skills

collaboration skills

Job description

Role:

I'm currently seeking a highly skilled and experienced FDC CMC Consultant to join a trusted client of mine. As an integral part of their organisation, the CMC Consultant will be responsible for providing expertise in Chemistry, Manufacturing, and Controls (CMC) for investigational new drug (IND) applications. The successful candidate will collaborate with cross-functional teams and external partners to ensure CMC requirements are met to support IND filings and regulatory approval.
About You

The ideal candidate will have a strong background in CMC development and possess extensive knowledge of IND requirements. You should have a proven track record of success in CMC strategy development and implementation, as well as a thorough understanding of regulatory guidelines and processes. Additionally, excellent communication and collaboration skills are essential for this role, as you will be working closely with internal and external stakeholders to drive CMC initiatives forward. Previous experience with FDC projects is a must.

If you are a dedicated and experienced CMC professional looking to make a meaningful impact in the field of drug development, we encourage you to apply for this exciting opportunity. Join us in our mission to bring innovative therapies to patients in need and contribute to a culture of diversity and inclusion in the workplace.