6 Month Contract - Lead Process Scientist Drug Substance

ZipRecruiter; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A recruitment agency is seeking a candidate to lead the transfer of new Drug Substance manufacturing processes. This role involves reviewing design and studies for a new biologic and preparing documentation for regulatory review. Candidates should have experience in process design and expertise in addressing gaps. This is a 6 month contract position located in the United Kingdom.

Qualifications

• Experience in Drug Substance manufacturing processes.
• Ability to prepare documentation for regulatory review.
• Expertise in process design and control strategies.

Responsibilities

• Lead review of design and studies for new biologic.
• Ensure reliable, cost-effective, safe DS operations.
• Identify and address gaps in process design.

Job description

Job Description

Are you able to lead the transfer of new Drug Substance manufacturing processes from development to manufacturing?

This 6 month contract is to lead a holistic review of all design and studies for a new biologic to move forward to process validation, including the following:

• Ensure process knowledge and control strategies support reliable, cost-effective, safe, and compliant DS operations.
• Prepare documentation to support process design for regulatory review.
• Identify any gaps in process design or control strategy.
• Address and close identified gaps before PPQ and commercial manufacture.

Please get in touch for more information [e-mail]