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Analytical Development Scientific Integrator - Associate Director

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Analytical Development Scientific Integrator - Associate Director

Locations: Beerse, Belgium
Functions: R&D
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Job Description

Requisition ID: 1905773144W

The Analytical Development (AD) Scientific Integration department is part of Janssen R&D and is responsible for the overall product analytical strategy in support of the Janssen Small Molecule R&D/commercial portfolio. This includes setting the analytical development strategies and managing planning and execution of analytical deliverables as the molecules transition through early development, late development and commercial phases.
As a Scientific Integrator you are the single point of contact for analytical development and the analytical expert in the CMC development/commercial teams. You are a core member of the CMC development team, with key interactions to coordinate analytical activities within the AD department, and cross functionally with discovery, drug substance, drug product, and commercial technical groups, regulatory, Quality & external partners.
Specific activities/deliverables that the AD Scientific Integrator is responsible for include:
* Developing drug development program strategies, based on an in depth understanding of analytical sciences and technologies to support clinical and commercial needs, technical transfers, timelines and costs
* Ensuring appropriate design, from feasibility to final commercialization, of analytical methods/specifications/stability in alignment with functional strategic technical platforms
* Specification management and setting retest period/shelf life for drug substance and drug products
* Interactions with multidisciplinary/multi-site groups, which may include external vendors and/or strategic suppliers
* Ensuring alignment/compliance with relevant FDA/EMA/ICH/JP/CHP/ANVISA/etc. guidances
* Authoring relevant submission documents/agency responses, ensuring analytical deliverables are met & aligning technical content for major and/or minor filings.
* Escalating potential issues to management and serving as coordinator in crisis management situations
* Managing analytical project budgeting
Qualifications
* MS degree in Chemistry, Pharmacy, or equivalent life sciences. Ph.D. degree 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/commercialization processes
* Proven knowledge of analytical or biochemistry in a R&D environment
* Demonstrated project management skills and leadership experience
* Excellent writing and communication skills is a must
* 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.
Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
1905773144W
Pharmaceuticals
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters

If you are an individual with a disability please check our Disability Assistance page for information on how to request an accommodation.

This site is governed solely by applicable U.S. laws and governmental regulations. Please see our Privacy Policy. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to the terms of our Legal Notice. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. Contact Us with any questions or search this site for more information.
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Analytical Development Scientific Integrator - Associate Director

Type de contrat: 
Contrat fixe, durée indéterminée
Fonctions: 
Chef De Projet
Niveau de carrière: 
Directeur
Postulez avant: