Lead CMC Chemist

Michael Page (UK); England; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading API manufacturer in Hertfordshire is seeking a CMC Chemist to optimize and develop processes for high-quality APIs. This hybrid role offers the chance to manage multiple innovative projects within a supportive team, ensuring compliance with regulatory guidelines and quality standards.

Qualifications

• Strong experience in CMC processes within the life science industry.
• First-hand experience in planning and delivering analytical methods.
• Comprehensive knowledge of GMP regulations.

Responsibilities

• Develop and optimise extraction, purification, and formulation processes.
• Carry out lab studies to evaluate processes.
• Prepare and review CMC documentation and support regulatory submissions.

Skills

CMC processes

Analytical methods

Regulatory requirements

Project management

Education

Degree in Chemistry or Pharmaceutical Sciences

Job description

• 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.