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 8 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
What’s in it for you ?
Caring for the world, one person at a time
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company.
We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.