Associate Director Scientific Integrator-1805653446W
CMC- Small Molecule Analytical Development - Scientific Integrator - Associate Director
The Scientific Integration group is responsible for developing analytical project development strategies, managing planning and execution of analytical deliverables and coordinating project transfer between phases (early, late development and commercial launch) for the Janssen Small Molecule R&D portfolio.
* The Scientific Integrator is the single point of contact (SPOC) for analytical development and the analytical expert in the CMC development teams. Core member of development team, with key interactions with API, drug product and commercial technical groups, regulatory organizations, Quality & external partners.
* Serve on development teams supporting major and/or minor filings for new products.
* Analytical Scientific Integrator will require extensive interactions with multidisciplinary and multi-site groups, which may include external vendors and/or strategic suppliers.
* Ensure participation and focused progress of analytical development groups/projects and other involved CMC functions and facilities.
* Develop program development strategy, with respect to analytical technology, clinical and commercial needs, tech transfer, timelines and costs.
* Ensure appropriate analytical design, from feasibility to final commercialization, including analytical methods/specifications/stability to ensure product quality.
* Support strategy to meet regional customer requirements in US, EMEA and ROW.
* Ensure products, processes, and supporting methods are aligned with strategic technical platforms for analytical methodologies.
* Able to support writing of amendments, annual reports, agency responses, and other submissions.
* A minimum of 8 years pharmaceutical industry experience.
* MS degree in Chemistry, Pharmacy, or equivalent life sciences. Ph.D. degree preferred.
* Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process.
* Demonstrated knowledge of analytical or biochemistry in a R&D environment.
* Demonstrated project management and leadership experience.
* Excellent writing and communication skills is a must.
* A proven 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.
Janssen Pharmaceutica N.V. (7555)