Senior Associate Scientist, Cell Therapy Process Development & Decisional Analytics - Johnson and Johnson

Johnson and Johnson is recruiting for a Senior Associate Scientist, Cell Therapy Process Development & Decisional Analytics within our growing API Cell and Gene Therapy Organization located in Spring House, PA site.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.jnj.com/.

Johnson and Johnson, Therapeutics Development & Supply (TDS) is seeking a highly motivated and collaborative Experienced Scientist to join our Decisional Analytics: Cell Therapy API development team. This group is responsible for generating rapid and robust, high throughput analytical platforms that support multiple cell therapy programs from early to late-stage clinical readiness for rapid progression of process development. Utilizing technical experience and knowledge, the successful candidate will be accountable for designing, optimizing, and executing assays to assess the attributes and quality of viral vectors and CAR-T cell therapy processes and products as a part of cell therapy manufacturing platforms. The chosen candidate will have the opportunity to work in a cross-functional matrix environment supporting industry leading Autologous/Allogeneic cell therapy programs that has brought numerous quality therapeutics to patients and made significant contributions to human health.

Key Responsibilities:

• Actively participate with the program teams and lead efforts to design, optimize and execute bioanalytical methods to assess Lentiviral and Cell therapy drug products during process development and product testing.

• Support, develop and optimize CAR-T process development platforms with a focus on rapid decisional analytics.

• Apply scientific expertise to evaluate alternative technologies, troubleshoot assays, and write technical documents involving both Autologous and Allogeneic CAR-T programs.

• Support CAR-T process and development, perform cell culture and decisional analytics assays associated with these activities as required.

• Routinely support non-clinical study sample analytical testing, as required.

• Participate in routine lab operations (Lab maintenance, safety inspections, etc.), equipment maintenance, reagent qualifications, and/or other duties.

• Analyze high volume data, present research findings and data to the group through both written and oral communication.

• Interact and collaborate with cross functional teams consisting of both internal and external groups (different departments, contractors).

• Responsible for leading or training other scientists regarding process, techniques, or tasks as required.

• Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording and laboratory equipment.

• Maintain detailed records and notebooks in a GXP compliant manner, safety, and environmental requirements.

• Work in a team environment, as well as contribute individually to meet project timeline and objectives.• Bachelor's degree in biology, immunology or other relevant scientific field, with at least 4 years of industry experience OR a Masters degree with at least 2 years of industry experience is required.

• Functional expertise and hands on laboratory experience in mammalian cell culture, aseptic cell culture and handling, viral vectors for primary and immortalized cells is required.

• Developing analytical assays with a particular focus on immune assays (Flow cytometry, Viral titer assays, potency and cell killing assays, ELISA, MSD platform, qPCR/ddPCR) is required.

• Familiarity with autologous cell therapy processes and viral vector analytical methods is highly desirable.

• Ability to design and execute experiments with minimal technical supervision, skills to perform data analysis and troubleshooting is required.

• Familiarity and/or hands on experience with cell therapy manufacturing steps, i.e. T cell selection, activation, transduction and expansion is strongly preferred.

• Experience with statistical tools to interpret and analyze analytical assays is required.

• The preferred candidate should be highly organized, able to handle multiple projects and a fast-paced lab environment with minimal supervision.

• Have deep intellectual curiosity, and excellent communication, interpersonal and collaborative skills.

• Experience maintaining electronic records via electronic notebooks, LIMS systems is preferred.

• Occasional weekend work may be required.

• This lab-based role is in Spring House, PA and may require up to 10% travel.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com