Analytical development, small molecules and drug development… If this sounds like your area of expertise, then we have just the role for you!
Join a renowned global biotechnology organisation and become the face and voice of the biopharmaceutics groups supporting the analytical method development of the small molecules portfolio. Better yet, this exciting opportunity comes with flexible home working when you’re not onsite in the beautiful town of Antwerp, Belgium.
The Analytical Integrator will lead a global sub team of AD scientists including Method Development/ Validation, Clinical Release & Stability, Advanced Material Characterization & Investigations, Pharmaceutical and Material Sciences, and Dissolution Sciences, integrating AD activities so that deliverables are being met balancing cost/time/quality. Specifically, the Scientific Integrator (SI) will provide strategic and scientific technical leadership, ensuring the focus on scientific excellence is maintained within the AD/CMC teams.
Main responsibilities will include:
- This role will be focused on defining and managing execution of the Analytical Development strategy and activities across all clinical and commercial phases, through in depth understanding of the compound properties and TPP (Target Product Profile), aligned with AD function, CMC team and CDT (Compound Development Team) who sets the overall compound strategy
- Ensuring appropriate design, from feasibility to final commercialization, of analytical methods/specifications/stability/characterisation in alignment with functional strategic technical platforms
- Specification management and setting retest period/shelf life for drug substance and drug products
- The scientific integrator will overview the project as core member of the CMC team, and has key interactions with API and DP scientific integrators, supply chain, Quality Assurance, CMC Regulatory Affairs, preclinical, clinical, Non-Clinical Safety and external consultants and vendors
- Ensuring alignment/compliance with relevant FDA/EMA/ICH/JP/CHP/ANVISA guidance
- Authoring relevant submission documents/agency responses, ensuring analytical deliverables are met & aligning technical content
- Responsible for and driving the analytical governance review for the assigned projects
- Managing the AD risk register and defining mitigation plans and ensuring rapid identification and resolution of problems
- Managing analytical project budgeting
- Ph.D. degree with post-doctoral experience and minimum 6 years of business experience of small molecule analytical development, CMC product development or other relevant product development experience.
- A minimum of 6 years pharmaceutical industry experience with strong demonstrated scientific acumen.
- Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development processes
- Proven knowledge of analytical or biochemistry in a R&D environment
- Demonstrated project management skills and leadership experience
- The ability to execute and get results through leading others
- Ability to foster team productivity and cohesiveness in a complex matrix environment
- Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organisation issues, structures and dynamics.