Johnson & Johnson Careers

Senior Scientist, Late Development Analytical Scientist Integrator

Malvern, Pennsylvania
R&D


Job Description

Requisition ID: 1878190104

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, located in Malvern, PA.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

 

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

 

The Biotherapeutic Analytical Development (BioTD AD) group is seeking a Scientific Integrator (SI) who will lead cross-functional analytical teams for biopharmaceutical programs in late stage clinical development through commercial approval. The individual would provide technical and strategic leadership, in addition to representing BioTD AD on the CMC team(s). Responsibilities include, but are not limited to, the following:
  • Lead a cross-functional scientific team consisting of members from each of the AD sub-functions
  • Lead the execution of the analytical control strategy
  • Be accountable to the CMC team for all analytical deliverables
  • Responsible for leading the analytical review of each program at governance meetings with support from subject matter experts
  • Effectively communicate project status, resources, budget and issues to senior management
  • Accountable for project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and escalation of issues
  • Interact with various stakeholders outside of Discovery Product Development and Supply (DPDS), including Commercial Manufacturing, Regulatory, Quality, Discovery, and external partners
  • Accountable for complete, consistent, comprehensive, and high quality regulatory documents
  • Additional responsibilities include method transfers to commercial sites, justification of specifications, and criticality analysis

 


Qualifications
  • Ph. D. in Analytical Chemistry, Biochemistry, immunology or related discipline with 3 years of industry experience in biopharmaceutical development OR a M. S. with 8 years of experience in biopharmaceutical development is required
  • At least 2 years of experience on cross-functional CMC teams or analytical subteams is required
  • Ability to work collaboratively in a complex, matrix environment is required
  • Strong communication and negotiation skills are required
  • A proven ability to execute complex plans in a matrix environment is preferred
  • In-depth knowledge of biotherapeutic development and analytical strategy is required
  • Knowledge of protein characterization, separation and/or bioassay testing is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


 


Primary Location
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
1878190104