Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a 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 budgetingQualifications
Ph.D. degree with post-doctoral experience and minimum 6 years of business experienceof small molecule analytical development, CMC product development or other relevant productdevelopment 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 organization issues, structures and dynamicsWhat is in it for you?
Contributing to our mission to continue to bring transformational new medicines to patients for a world without disease.
Being part of a motivated and experienced research team in an innovative working environment
Through mentoring programs, e-university and on the job training, we ensure your personal development in a global company
A competitive salary, on-site sport accommodations, health / energy programs and other benefits for you and your family
Flexible working hours (40 h / week), no fixed holiday planning with 39 holidays and possibility to work at home for non-laboratory related tasksPrimary LocationBelgium-Antwerp-Antwerp-Other LocationsBelgium-Antwerp-BeerseOrganizationJanssen Pharmaceutica N.
V. (7555)Job FunctionR&DRequisition ID2005837459W