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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:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, 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

We are searching for the best talent for a Principal Scientist, CAR-T Analytical Scientific Integrator – Advanced Therapies to be in Malvern, PA.

Purpose: The Principal Scientist, CAR-T Analytical Scientific Integrator will provide analytical, technical and strategic leadership to a matrixed team, in addition to representing Advanced Therapy (BioTD-AD) on the CMC team(s). This role is also responsible for the output and quality for technical reports and regulatory documentation through the writing of technical analytical content for regulatory submission and provide strategy to meet regional customer requirements in the U.S., EMEA and Asia Pac.

You will be responsible for :

• Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the Analytical Development (AD) sub-functions.

• Represent AD on the CMC team and accountable for all AD project deliverables.

• Coordinate the execution of cross-site, cross-functional analytical deliverables, for method development, process scale-up and tech transfer, through commercialization.

• Accountable for project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and heightened concerns.

• Collaborate with various partners outside of DPDS, including Commercial Manufacturing, Regulatory, Quality, Discovery and external partners.

• Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.

• Lead the analytical review of programs at governance meetings with support from subject matter experts.

• Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.

• Effectively communicate project status/overview, resources, budget, and issues to senior management.

Qualifications / Requirements:

Education:

• PhD in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development OR a Master's degree with 5+ years of experience in biopharmaceutical development OR a Bachelor’s degree with 8+ years of relevant experience is required.

Experience & Skills:

Required:

• 2+ years of experience on cross-functional CMC teams or analytical sub-teams with the ability to lead and implement complex plans/deliverables in a matrix environment is required.

• Knowledge of analytical development, experience in cell therapy & viral vector is required.

• Ability work collaboratively in a complex environment is required.

• Excellent oral and written communication skills are required.

• Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required.

Preferred:

• Strong negotiation skills with a proven ability to complete and get results in a complex environment is preferred.

• Knowledge of potency assays and/or cellular immunology is preferred.

• Knowledge of basic immunology techniques is required, including mammalian cell culture, FACS, immunofluorescence, ELISA, and qPCR is preferred.

• Knowledge of the development and registration of cell therapy products is preferred.

• Ability to make timely decisions and operate effectively in times of ambiguity is preferred.

• Strong analytical problem solving, planning and organizational skills are highly preferred.

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.