Lead CMC Chemist

Hertfordshire Permanent View Job Description
As a Lead CMC Chemist you will be responsible for supporting development, validation and regulatory submissions of APIs whilst ensuring compliance with industry and regulatory requirements. The role is a blend of hands-on chemistry, project management and supporting with regulatory submissions.
  • A fantastic opportunity to take ownership of CMC projects
  • Working with a close-knit innovative team optimizing processes to deliver APIs

About Our Client

The client are a leading API manufacturer based in Hertfordshire. They have a small but innovative team dedicated to producing high quality APIs.

Job Description

As a CMC Chemist you will:

  • Develop and optimise a range of processes inclusive of extraction, purification and formulation for APIs
  • Carry out development studies in a lab setting to evaluate parameters, scalabiltiy and robustness of processes
  • Develop and validate suitable analytical methods for analysis of extracts and APIs
  • Prepare and review CMC documentation including technical reports, batch records and regulatory dossiers
  • Provide technical expertise and data to support regulatory submissions

This role offers a hybrid working model, initially with 4 days on site per week.

The Successful Applicant

To be successful you will have:

  • A degree or higher qualification in Chemistry, Pharmaceutical Sciences, or a related field.
  • Strong experience in CMC processes within the life science industry.
  • First-hand experience planning and delivering analytical methods and development studies
  • Comprehensive knowledge of regulatory requirements and guidelines inclusive of GMP.
  • Proven ability to manage multiple projects simultaneously.

What's on Offer

This is a fantastic opportunity to join a small yet leading business in the field taking ownership of CMC projects.

Contact
Jason Hines
Quote job ref
JN-062025-6762832
Phone number
+441727730142

Job summary

Job function
Life Sciences
Subsector
Scientific
Sector
Healthcare / Pharmaceutical
Location
Hertfordshire
Contract type
Permanent
Consultant name
Jason Hines
Consultant phone
+441727730142
Job reference
JN-062025-6762832