Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a Principal Scientist (Associate Director) – Analytical Development Scientific Integrator, based in Beerse, Belgium to support our small molecule portfolio.
Janssen Research & Development area develops treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine. The Principal Scientist Scientific Integrator is the AD (Analytical Development) representative and single point of contact on the CMC (Chemistry Manufacturing & Controls) new product development teams.
The Principal Scientist leads 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 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 guidances
• 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
• Masters Degree in Chemistry, Pharmacy, or equivalent life sciences. Ph.D. preferred.
• 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 organization issues, structures and dynamics
Janssen Pharmaceutica N.V. (7555)