Senior Scientist, Bioanalysis – Cellular Immunogenicity

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.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Pharmacokinetics & Pharmacometrics
Job Category:
Scientific/Technology
All Job Posting Locations:
Spring House, Pennsylvania, United States of America
Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Bioanalysis – Cellular Immunogenicity located in Spring House, PA.

The Bioanalytical Discovery and Development Sciences (BDDS) organization develops, validates, and conducts bioanalytical sample analysis across the entire J&J Innovative Medicines (JJIM) R&D portfolio from discovery through development. We are looking for an accomplished and dedicated Senior Scientist to design and perform cellular immunogenicity assays within BDDS for Johnson & Johnson portfolio projects spanning all modalities and therapeutic areas from nonclinical studies to post-market clinical development.

Principal Responsibilities:

• Independently lead and perform the design, method development, validation, Good Laboratory Practices (GLP)/Good Clinical Laboratory Practice (GCLP) bioanalysis and reporting for various cellular immunogenicity assays, including ELISpot, multiplex FluoroSpot, multi-parametric flow cytometry, multiplex cytokine assays, innate immune response assays etc. to assess preclinical and clinical safety and efficacy of various Johnson & Johnson modalities and programs, including gene therapy, cell therapy, therapeutic vaccines, siRNA, therapeutic antibodies, etc.
• Evaluate and develop new methodologies for innate and adaptive cellular immunogenicity testing and perform optimization and troubleshooting of current methods and processes.
• Help oversee Peripheral Blood Mononuclear Cells (PBMC) processing and cellular immunogenicity assays for outsourced projects and interprets experimental results from Contract Research Organizations (CROs).
• Familiar with the in-silico tools; in vitro and ex vivo assays for immunogenicity risk assessments of genomic medicines and biologics.
• Work in a regulated GLP/GCLP environment under limited supervision with a high level of autonomy and fosters a collaborative and inclusive environment.
• Promote assigned project activities through hands-on data generation, quality control (QC) and data analysis.
• Utilize advanced computer software packages to collect, analyze, and interpret cellular immunogenicity data.
• Interpret and analyze complex study data and investigates mechanism of action for research targets and compounds in preparation for final reports.
• Set priorities for experimental work to ensure adequate progress of team projects and objectives. Ensure laboratory productivity as well as compliance with good laboratory practices and other regulatory guidelines.
• Anticipate needs and plans for the purchase, use, computer system validation, and maintenance of laboratory equipment and reagents for regulated studies.
• Draft, execute and serve as lead author on work instructions, standard operating procedures (SOPs), technical reports, peer reviewed manuscripts and patent filings.
• Coach more junior colleagues in techniques, processes, and responsibilities.
• Drive collaboration across research groups and effectively communicate results and recommendations to colleagues and project teams on the operation and interpretation of cellular immunogenicity assessments.
• Actively participate in internal seminars and relevant external scientific meetings as appropriate to support team goals.
• Keep up-to-date with documentation, published literature and regulatory guidance’s to develop knowledge of current academic and industry practices and apply to internal Johnson & Johnson projects and processes.
• Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• May perform other duties as assigned.

Qualifications:

• A minimum of a Master’s degree in Life Sciences, Biology, Immunology or a related discipline is required. Ph.D. in Life Sciences, Biology, Immunology or a related discipline is preferred.
• A minimum of 4 years of relevant industry experience in a regulated area or a minimum of 2 years of relevant industry experience in a regulated area with a Ph.D. is required.
• Hands-on experience and strong knowledge of GLP/GCLP immunogenicity bioanalysis and regulatory guidelines to assess safety and efficacy of genomic medicine modalities and biologics is required.
• Demonstrated experience in method development, validation and bioanalysis using ELISpot, multiplex FluoroSpot, multi-parametric flow cytometry (10+ colors), multiplex cytokine assays (Meso Scale Discovery (MSD), Luminex), innate immune response assays (PBMC, DC-T cell), and/or other cell-based immune assays is required.
• Strong knowledge of cellular techniques, including mammalian cell culture, handling and processing of human and animal (non-human primates (NHP), mice, rats, dogs, etc.) blood, PBMCs and tissues and/or aseptic techniques, is required.
• Familiarity with BSL2 safety practices for working in the laboratory is required.
• Knowledge of T cell and B cell biology and immunological mechanisms of disease and biotherapeutics is preferred.
• Experience with immunogenicity risk assessments for various modalities is preferred.
• Experience with in-silico tools for epitope prediction (i.e., Immune Epitope Database (IEDB), EpiVax etc.) is preferred.
• Proficiency with data analysis software, including Excel, PowerPoint, Prism, LabVantage, SoftMax, Flowjo and/or other relevant scientific software, is required.
• Strong data science skills, such as Excel macros, R programming and statistical analysis, preferred.
• Must have excellent verbal and written communication skills.
• Must have strong interpersonal, organizational and documentation skills.
• Must have strong motivation to quickly learn new skills, grow as a scientist and adapt to challenges of the job.
• The ability to multi-task, prioritize and plan based on project needs, and work in a fast-paced dynamic environment.
• The ability to independently perform experimental design, including generation, analysis and QC of data and interpretation of results, is required.
• The ability to interact and collaborate effectively in a cross-functional team environment is required.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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