Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Scientist, located in Malvern, PA.
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.
Large Molecule Analytical Development is seeking a Scientific Integrator (Senior scientist level) who will lead the analytical support of PDMS outsourced projects and to represent large molecule analytical development in project CMC teams.
Primary responsibilities include:
- Lead a cross-functional analytical team consisting of members from each of the analytical sub-functions for an assigned project
- Interact with various stakeholders including Commercial Manufacturing, Regulatory, Quality, Discovery, and external partners
- Additional responsibilities include method transfers, analytical control strategy, justification of specifications, and criticality analysis.
- Ph.D. in Biochemistry, Analytical Chemistry, or related discipline with at least 3 years of experience in biopharmaceutical development OR M.S. degree with at least 8 years of experience in biopharmaceutical development is required
- Experience on cross-functional CMC teams is preferred
- Must have the ability to work collaboratively in a complex, matrix environment
- Experience in working with CMOs is required
- In-depth large molecule Analytical Development knowledge and experience is required
- Understanding of method develop, method transfers, and qualifications are required
- Knowledge of specification set up is preferred
- Strong negotiation skills with a proven ability to execute and get results in a matrix environment
- Ability to make timely decisions and operate effectively in times of ambiguity
- Strong analytical problem solving, critical thinking and attention to detail
- Strong planning and organizational skills
- Ability to effectively listen, filter information and escalate issues as appropriate
Janssen Research & Development, LLC. (6084)Job Function