Technical Integrator Analytical Development Job ()

Beschrijving:

– Technical 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).
– Analytical Technical Integration will require extensive interactions with multidisciplinary and multi-site groups, which may include external vendors and/or strategic suppliers.
– Support Analytical projects within the CMC Organization and will interface with key stakeholders for critical analytical projects for small and large molecules.
– Ensure participation and focused progress of Analytical development groups/projects and other involved CMC functions and facilities.
– Support strategy to meet regional customer requirements in EMEA, Asia Pac and US.
– Develop program development strategy, with respect to analytical technology, clinical and commercial needs, tech transfer, timelines, costs in consultation with the Scientific Director.
– Provide Analytical design, from feasibility to final commercialization. Includes design requirements of analytical methods/specifications to ensure product quality.
– Ensure products, processes, and supporting methods are aligned with strategic technical platforms for analytical methodologies.
– Ensure design alignment with customer needs, early to late development and manufacturing for small molecules and large molecules.
– Core member of development team, with key interactions with API, Drug Product Team Leaders, JSC technical groups, regulatory organizations, quality, & external partners.
– Serve on development teams supporting major and/or minor filings for new products.
– Able to support writing of amendments, annual reports, agency responses, and other submissions.
– Responsible for authoring documents/dossiers as Analytical Technical Integration lead.

– A minimum of 8 years pharmaceutical industry experience. Ph.D. degree is preferred.
– Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process.
– MS Degree in Chemistry, Pharmacy, or equivalent life sciences degree.
– 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.

Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations:Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D

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