SCIENTIST, ANALYTICAL DEVELOPMENT TECH TRANSFER

Janssen Research & Development, L.
.
., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Analytical Development Tech Transfer located in Malvern, PA.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
The Biotherapeutics Development-Analytical Development (BioTD-AD)- Cell & Gene Therapy (CGT) group is seeking an energetic, highly motivated scientist to support autologous CAR-T cell therapies.
The Scientist will serve as an analytical technical expert for cell count and viability, cell-based potency as well as ELISA based method development, qualification, assay validation and transfer activities.
The individual will be a point of contact person overseeing test method technology transfer activities to internal and external CAR-T manufacturing sites to support Janssen’s CAR-T drug development and production.
The scientist will have the opportunity to engage in multi-functional teams.
They will learn from and contribute to industry-leading drug discovery/development programs that has brought numerous quality therapeutics to patients and has made significant contributions to human health.
Primary responsibilities.
· Serve as an analytical technical subject matter expert for cell count and viability, cell-based potency as well as ELISA/MSD based method development, qualification, assay validation and transfer activities.
· Plan, conduct, and advise on analytical transfer activities to internal and external CAR-T manufacturing/testing sites.
· Lead and participate in scientific investigations and trouble-shoot process issues that arise during development, technology transfer, or scale-up.
· Drive documentation of technical program including writing and reviewing.
Protocols, technical transfer reports, investigation memos, technical reports and analytical sections for regulatory filings.
· Demonstrate excellent communication and interpersonal skills; act as liaison and point of contact for local teams and global operations; serve as representative on cross-functional teams.
· The candidate is expected to work effectively in a team environment and well as contributing individually to meet project objectives and timelines.
Other duties will be assigned, as necessary.
Qualifications Required.
· Ph.
.
with 0-1+ years’ experience OR Master’s degree with at least 2-3+ years of experience OR Bachelor’s degree with at least 4-5+ years’ experience in an appropriate scientific discipline (cell biology, immunology, biological science, or related field) is required · Strong knowledge of regulatory guidance and requirements for method qualifications/validations and transfer testing for NDA/BLA/MAA filings and control of commercialized products.
· Extensive experience in analytical method qualification/validation and technology transfer characteristics · Experience in cell count and viability OR cell-based potency and ELISA/MSD method development and method qualification/validation · Strong analytical problem solving, planning and organizational skills · Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines · Ability to work collaboratively in a complex and manage multiple projects and workstreams simultaneously · Ability to communicate project results, findings and data to management in a clear and timely fashion · Excellent oral and written communication skills Preferred.
· Hands-on experience with CAR-T or other cell and gene therapy products · Experience with the development and registration of cell therapies 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.