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FDC CMC Consultant

Barrington James Limited

Greater London

On-site

GBP 60,000 - 100,000

Full time

19 days ago

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Job summary

An established industry player is seeking a highly skilled FDC CMC Consultant to join their team. This role is pivotal in providing expertise in Chemistry, Manufacturing, and Controls (CMC) for investigational new drug applications. The successful candidate will leverage their extensive knowledge of CMC development and regulatory guidelines to support IND filings and approvals. Excellent communication and collaboration skills are essential as you will work closely with various stakeholders to drive CMC initiatives forward. If you are passionate about making a meaningful impact in drug development, this is an exciting opportunity to contribute to innovative therapies and a diverse workplace.

Qualifications

  • Strong background in 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 strategy development
Regulatory guidelines knowledge
Communication skills
Collaboration skills
FDC project experience

Education

Degree in Chemistry or related field

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.

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