Requirements: English
Company: WhatJobs
Region: vlaanderen, belgique , Flanders
Principal Consultant CMC antibodies/biologics
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 lifecycle management). We work globally with startups, biotech, medtech, pharma, and investors. Our flexible, cross-functional teams address complex challenges by leveraging broad multidisciplinary expertise.
We Care, We Adapt & Drive to Excel : our core values guide our approach and engagement with clients and colleagues.
For more information, visit our website: .
Your role
We seek a Principal Consultant with experience in early development of antibodies/biologics to strengthen our CMC team.
The CMC Principal Consultant will lead and execute CMC development programs, representing CMC in client development teams, overseeing Drug Substance, Drug Product, and Clinical Supply Management.
Key responsibilities include:
- Leading multiple cross-functional CMC teams end-to-end
- Overseeing GMP C(D)MOs selection and management
- Authoring regulatory CMC documentation
- Developing CMC strategies aligned with overall program goals
- Managing and mitigating CMC risks
- Managing budgets and timelines for CMC activities
- Ensuring delivery of clinical and launch drug supplies according to development plans
Your knowledge & experience
- MSc/PhD in Biomedical Sciences, Bioengineering, Biology, Industrial Pharmacy, Chemistry, or related fields
- At least 10 years experience in CMC drug development, registration, or GMP production
- Experience in chemical/biological process or formulation development
- Knowledge of physico-chemical characterization of biologics and analytical techniques for release and stability testing
- Experience preparing scientific, technical, and regulatory documentation in CMC
- Understanding of pharmaceutical legislation (ICH/GMP) and healthcare development processes
- Fluency in English
- Strong customer focus and ability to build strategic partnerships
- Innovative mindset, embracing change and striving for excellence
- Ability to maintain focus and effectiveness under pressure
- Excellent leadership skills to motivate and engage teams
We are committed to fostering diversity and inclusion in the workplace. Send your motivation letter and CV to .
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