Our client, a small Biotech company based in the South East of England are recruiting a CMC Lead Scientist. This is a critical role in which the candidate will deliver cutting-edge drug development/medical device projects. The role is based in the Project Team and will be across a wide variety of projects delivering against agreed project strategies.
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 ideal candidate will have:-
- A minimum of 10 years hands-on CMC experience to assist with the development of our novel products.
- You will have detailed GMP oversight and accountability for the manufacture of device(s) as well as drug substance (DS) and drug product (DP);
- You will develop innovative CMC-centric strategies throughout the product lifecycle.
- You will bring CMC focus and direction to the companies device, health-care and global business opportunities.
- 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
- 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
- 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