Lead CMC Chemist

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.

Client Details

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

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.

Profile

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.

Job Offer

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