Biologics CMC Lead — Associate Director

Pharmaron; Liverpool; On-site; GBP 90,000 - 130,000; Full time

Job summary

Pharmaron is seeking an Associate Director, CMC Lead for a 12-month fixed-term contract in Liverpool. You will lead the CMC strategy for client programs, coordinating between Process Sciences, Analytical Sciences and Manufacturing to ensure regulatory alignment and timely progression through development and licensure.

The role acts as a bridge between customers and internal teams, delivering high-quality consultancy and submission support while driving robust, phase-appropriate control

Qualifications

• PhD or MSc in Life Sciences or equivalent industrial experience.
• 10+ years leading process and analytical transfer activities for development and GMP projects.
• Strong knowledge of global CMC regulations.
• Experience supporting regulatory submissions and client consultancy.

Responsibilities

• Lead CMC strategy for client programs across development to commercialization.
• Ensure alignment of development, manufacturing, and control strategies with regulatory expectations (MHRA, EMA, FDA).
• Lead preparation and review of CMC regulatory submission dossiers and interpret regulatory guidance.
• Act as CMC sponsor on client projects and ensure robust, phase-appropriate control strategies.
• Oversee validation activities for manufacturing processes, analytical methods, and cleaning procedures.
• Provide consultancy to customers and support project delivery with technical study design and reporting.
• Identify regulatory trends and implement changes within the organization.

Skills

CMC Strategy

Regulatory Submissions

Project Leadership

Cross-functional Collaboration

Education

PhD/MSc Life Sciences

Job description

Pharmaron is seeking an Associate Director, CMC Lead for a 12-month fixed-term contract in Liverpool. You will lead the CMC strategy for client programs, coordinating between Process Sciences, Analytical Sciences and Manufacturing to ensure regulatory alignment and timely progression through development and licensure.

The role acts as a bridge between customers and internal teams, delivering high-quality consultancy and submission support while driving robust, phase-appropriate control