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
• 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.
Janssen Pharmaceutica N.V. (7555)