Principal Scientist, Product Characterization – Advanced Therapies Full-time

Principal Scientist, Product Characterization – Advanced Therapies

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.

We are searching for the best talent for a Principal Scientist, Product Characterization – Advanced Therapies to be in Malvern, PA.

Purpose:

The Biotherapeutics Development – Analytical Development (BioTD – AD) group is seeking an energetic, highly motivated Principal Scientist to focus on product characterization for advanced therapy modalities. The individual would work with the team to develop comprehensive product characterization approaches for advanced therapy modalities 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 characterization assays and will have the opportunity to engage in multi-functional teams. She/He 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.

You will be responsible for:

• Define and implement product characterization strategy for cell and gene therapy (CGT) modalities from early development to late stages of development.
• Lead the identification and justification of CQAs for CGT products using the Quality by Design (QbD) principles.
• Lead the execution of the advanced methodologies associated with comparability and deep characterization of cell and gene therapy.
• Develop and refine the control strategy linking process parameters to CQAs.
• Apply DOE and statistical modeling to establish structure-function and process-product relationships.
• Author or coordinate appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address product characterization related inquiries.
• Effectively communicate characterization results and scientific data to cross-functional teams, project teams, and health authority as needed.
• Promote strong partnerships and collaboration with Process Development functional leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery.
• Contribute to technical forums both internal and external to the company to share knowledge and approaches related to deep product characterization strategies as they relate to cell and gene therapy products.
• Identify/collaborate with partners in academia or industry to implement innovative ideas or characterization approaches.
• Stay up to date with industry standards, guidelines, and regulatory requirements related to Advanced therapies, comparability studies and product characterization.
• Author comprehensive reports and presentations to communicate findings and technical data to internal and external stakeholders.
• Contribute to the development and enhancement of standard operating procedures (SOPs) and best practices for product characterization.

Qualifications:

• Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development OR a Bachelor's or Master's degree with 6-8 years of relevant experience is required.
• 2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products.
• Demonstrated expertise in CQA assessment and developing control strategies for advanced therapies.
• Experience with the design, execution and optimization of a broad range of analytical techniques for orthogonal characterization of cell therapy and gene therapy products.
• 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.
• Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices.
• Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required.
• Ability to work collaboratively in a complex, matrix environment.

Experience Preferred:

• Understanding of the connections between clinical, process/product development, and biological outcomes
• Experience with regulatory submissions and interactions with agencies such as the FDA or EMA.
• Previous experience in project management or leading cross-functional teams is a plus.
• Proficiency in statistical analysis and equivalency assessment is a plus

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.

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.