Requirements: English
Company: WhatJobs
Region: Antwerp , Flanders
Principal consultant CMC Small Molecules
12 May 2025
Our company
2 Bridge is a Belgian-based consultancy company offering expert guidance and support on all key disciplines of healthcare product development (discovery, pre-clinical, clinical, and product development, registration, and life-cycle management). We work globally with startups, biotech, medtech, pharma, and investors. 2 Bridge typically operates via flexible and cross-functional teams, aligned to project needs. Our flexible, cross-functional team structure allows us to address complex challenges, leveraging broad multidisciplinary expertise.
We Care, We Adapt & We Drive to Excel : our core values guide our approach and shape our engagements with clients and each other.
For more information, visit our website at .
Your role
We are seeking a Principal Consultant with experience in early development of small molecules to strengthen the CM&C team at 2 Bridge.
The CMC Principal Consultant will demonstrate leadership in the development and execution of CMC development programs.
As the CMC representative in our clients'' Development Teams, you will supervise and manage CMC programs, overseeing Drug Substance, Drug Product, and Clinical Supply Management.
Key responsibilities include:
- Leading multiple cross-functional CMC teams end-to-end
- Overseeing the selection and management of GMP C(D)MOs
- Overseeing the authoring of regulatory CMC documentation
- Developing CMC strategies aligned with overall program development strategies
- Managing and mitigating CMC risks
- Managing CMC budgets and timelines
- Overseeing the delivery of clinical and launch drug supplies according to development plans
Your knowledge & experience
- MSc/PhD in Industrial Pharmacy, Chemistry, Biomedical Sciences, Bio-engineering, Biology, or equivalent
- At least 10 years of experience in CMC drug development, registration, or GMP production
- Chemical process development and/or formulation development expertise
- Physico-chemical characterization of chemicals and knowledge of analytical techniques for release and stability testing
- Experience in preparing scientific, technical, and regulatory documentation in CMC
- Knowledge or interest in pharmaceutical legislation (ICH/GMP, etc.) and healthcare development processes
- Fluency in English
- Ability to build strong, long-term strategic partnerships with clients through high-quality service and customer-focused solutions
- Embraces change and innovation, striving for excellence
- Maintains focus and effectiveness in complex, high-pressure situations
- Excellent leadership skills to ensure team performance and engagement
We are committed to fostering a diverse and inclusive workplace where everyone is welcome regardless of age, gender, nationality, ethnicity, or physical abilities.
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