Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, located in Spring House or Malvern, PA, Titusville or Raritan, NJ, Beerse, Belgium, or Mumbai, India.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/
for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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. Additional responsibilities include but are not limited to the following:
- Serve on development teams supporting major and/or minor filings for new products
- 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
- BS degree in Chemistry, Pharmacy, or equivalent life sciences with at least 8 years pharmaceutical industry experience OR a MS degree in Chemistry, Pharmacy, or equivalent life sciences with at least 7 years pharmaceutical industry experience OR a Ph.D. degree in Chemistry, Pharmacy, or equivalent life sciences with at least 6 years pharmaceutical industry experience is required
- Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process is required
- Demonstrated knowledge of analytical or biochemistry in a R&D environment is required
- Demonstrated project management and leadership experience (coaching, mentoring, leading projects) is required.
- Excellent writing and communication skills is a must.
- Experience on cross-functional CMC teams is preferred
United States-New Jersey-TitusvilleOther Locations
North America-United States-Pennsylvania-Spring House, Asia Pacific-India-Maharashtra-Greater Mumbai, North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function