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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: CMC

Location: United Kingdom

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 - www.proclinical.com/send-cv

#LI-119616263_JO1

#ClinicalResearch

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