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 the project need. Our flexible, cross-functional team structure allows us to address the most complex challenges, leveraging our 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, we invite you to explore our website www.2Bridge.be.

Your role

We are looking for a Principal consultant with experience in early development of antibodies/biologics to strengthen the CM&C team of 2 Bridge.

The CM&C Principal consultant will demonstrate leadership regarding the development and execution of CMC development programs.

As CMC representative in the Development Teams of our clients, you will supervise and manage the CMC programs covering oversight on Drug Substance, Drug Product and Clinical Supply Management.

Key responsibilities will include:

  • Lead multiple cross-functional CM&C teams end-to-end
  • Oversight on selection and management of GMP C(D)MOs
  • Oversight on authoring of regulatory CM&C documentation
  • Development of CM&C strategy in line with overall program development strategy
  • Management and mitigation of CM&C risks
  • Management of CM&C budget and timelines
  • Oversight of delivery of clinical and launch drug supplies in accordance with development plans

Your knowledge & experience:

  • MSc/PhD in Bio-medical sciences, Bio-engineering, Biology, Industrial Pharmacy, Chemistry, or equivalent.
  • CM&C drug development, registration or GMP production (at least 10 years ’ experience)
  • Chemical/biological process development and/or formulation development.
  • Physico-chemical characterisation of biologicals and knowledge of different analytical techniques used for release and stability testing.
  • Preparation of Scientific, Technical and Regulatory documentation within the area of CM&C.
  • Knowledge and/or interest in pharmaceutical legislation (ICH/GMP,…) and the overall process of health care development
  • Fluency in English

Your competencies:

  • You champion high-quality service and customer-focused solutions, being able to build strong long-term strategic partnerships with our clients.
  • You embrace change and bring innovation, striving for excellence.
  • You maintain focus, helicopter view and effectiveness in complex and high-pressure situations.
  • You have excellent leadership skills and ensure the team performs at its highest level, while keeping everyone fully engaged.

We are an employer 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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