CMC TECHNICAL LEAD
OXFORD | FULL TIME
The role of CMC Technical Lead at 30 Technology is a critical role in successfully delivering innovative drug development/medical device projects. Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed project strategies.
This role is a great career opportunity for a CMC Technical Lead who is highly motivated to succeed and enjoys the fast-moving pace that a small biotech company brings. We are looking for an experienced CMC Technical Lead to assist with the development of our innovative products.
This role is based in Oxford, UK.
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
Prepare and review regulatory documentation for clinical trials (including IMPDs)
- Bachelor’s degree in a scientific or technical subject
5 years + experience in EU regulatory standards with a proven track record of writing and submitting device regulatory documentation to appropriate ISO and FDA standards
Knowledge of pre-market and post-marketing regulatory requirements and processes for medical devices in EU, as well as knowledge of upcoming changes under MDR
Excellent written and verbal communication skills
Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners
To be considered for this exciting opportunity, please submit your CV and a cover letter to jenny.howell@30.Technology
Closing date: 15th October 2019
30 Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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.