CMC LEAD SCIENTIST
ABINGDON | FULL TIME
The role of CMC Lead Scientist at 30 Technology is a critical role in successfully delivering cutting-edge drug development/medical device projects. Sitting on the Project Team, you will work as a player-coach 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. We are looking for candidates with 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); developing innovative CMC-centric strategies throughout the product lifecycle is a key component of this role. As a vital part of the project/regulatory team, you will bring CMC focus and direction to 30 Technology’s 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
- 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 be considered for this exciting opportunity, please submit your CV and a cover letter to email@example.com.
Closing date: 5th September 2020.
30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.
30 TECHNOLOGY Therapeutic Nitric Oxide