CMC Lead Scientist

Highly Competitive
  1. Permanent
  2. CMC
  3. United Kingdom
Oxford, England
Posting date: 24 Jul 2020
This vacancy has now expired

This role is a great career opportunity for a senior level CMC Lead Scientist who is highly motivated to succeed and thrive in the fast-moving pace that a small biotech company brings. The Oxford based organisation is dedicated to developing innovative CMC strategies throughout the product lifecycle.

Job Responsibilities

  • Develop and execute the CMC strategy and plans for multiple projects
  • Manage CROs/CMOs in the development of manufacturing processes and analytical methodology
  • Facilitate problem-solving, contingency planning, and decision-making related to all CMC aspects
  • Advance the hands-on independent Lead Scientist role
  • Prepare and review regulatory documentation from IND/IMPDs to market release
  • Able to provide innovative solutions to complex multi-component regulatory problems

Skills and Requirements

  • Minimum MSc, PhD preferable - in a scientific or technical subject
  • 10 years + experience in the biotechnology or pharma industry with a primary focus on CMC program management/regulatory affairs
  • Familiarity with drug development phases and global regulatory requirements
  • Experience in sourcing and managing CMO
  • Self-governing and capable of agile-decision making
  • Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners
  • Excellent written and verbal communication skills

To Apply

In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at 0203 846 0646 or upload your CV on our website -