Principal Scientist, Product Characterization – Advanced Therapies

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, 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 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.

Required:

• 2+ years of analytical control strategy experience on advanced