Senior Scientist, Cell Therapy Method Development

Johnson & Johnson • Malvern, PA

65d • Onsite

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â 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.â Learn more at https://www.jnj.com 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 Senior Scientist, Cell Therapy Method Development to be onsite in Malvern, PA. Purpose: The Therapeutics Development & Supply - Analytical Development (TDS - AD) group is seeking an upbeat, highly motivated Senior Scientist to focus on potency analytical development for cell therapy products. The individual would work with team to develop functional potency strategies for lentivirus and CAR-T cells that will be endorsed by the health authorities. A successful candidate will have experience with the design, execution and optimization of a broad range of cell-based assays and will have the opportunity to engage in multi-functional teams. They will learn from and contribute to industry-leading drug discovery/development programs that have brought numerous quality therapeutics to patients and have made significant contributions to human health.

Requirements

• A minimum of a Bachelor's degree is required
• Advanced degree (Master's, PhD) is preferred.
• Ph.D. or equivalent advanced degree in Biochemistry, Virology, Biological Science, or a related field OR a Master's degree with 4+ years of experience in biopharmaceutical development OR a Bachelor's degree with 6+ years of relevant experience is required.
• At least 4-6 years of relevant pharmaceutical, industry, or academic experience.
• Extensive experience in cell-based potency method development for viruses and cell therapies, including assay design and method robustness
• Extensive experience in potency strategies for cell therapies and regulatory recommendations
• Experience with method validation and method transfer to a QC environment; including in-depth knowledge of ICHQ14 and ICHQ2(R2)
• Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data
• Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly.
• Strong analytical problem solving, planning and organizational skills

Responsibilities

• Leading method development, validation, tech transfer, and lifecycle support activities for cell-based potency methods.
• Working collaboratively on a matrix environment, supporting and mentoring team members.
• Supporting regulatory filings, including INDs and BLAs.
• Representing the department on cross-functional and external teams and acting as a technical expert on potency.
• Communicating complex technical concepts to partners.
• Accurately capturing data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees