Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Biotherapeutics R&D Job Category: Scientific/Technology All Job Posting Locations: Leiden, Netherlands, Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America Job Description: We are searching for the best talent for a Principal Scientist, Product Characterization – Advanced Therapies to be in Malvern, PA, Spring House, PA, or Leiden, Netherlands. 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 In Vivo CAR-T 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 in vivo CAR-T including LNP, mRNA and targeted LV 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 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 Required Skills: Preferred Skills: Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research