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

Purpose:

The Biotherapeutics Development - Analytical Development (BioTD - AD) group is seeking an upbeat, highly motivated Principal Scientist to focus on analytical comparability and product characterization for advanced therapy modalities. The individual would work with team to develop product comparability study 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. They 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.

Primary Responsibilities:

·Design and lead the execution of analytical comparability studies for advanced therapy modalities across various stages of development.

·Lead the execution of the advanced methodologies associated with comparability and deep characterization of cell and gene therapy.

·Author or coordinate appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address CMC-comparability and product characterization related inquiries.

·Optimally communicate comparability study plans, statistical justifications, and results and scientific data to cross-functional teams, project teams, and health authority as needed.

·Collaborate to develop innovative approaches to challenging solutions for analytical comparability strategy and product characterization.

·Promote positive relationships 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 collaborators.

·Champion the development and enhancement of standard operating procedures (SOPs) for comparability assessments.

Qualifications:

Required:

• 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 BS or MS with 6-8 years of experience of overall 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.

• Familiarity with Quality by Design (QbD) principles and their application in comparability assessments.

• Experience with the design, execution and optimization of a broad range of analytical techniques for the 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

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.