Technical Development Principal Scientist

Job Description Job Title: Technical Development Principal Scientist Job Description This role is a senior-level position within Analytical Development, focused on creating and implementing robust analytical methods to characterize and release cell therapy products. You will use state-of-the-art analytical assays to support process development, product characterization, release, and stability, while serving as a subject matter expert on cross-functional teams. The position is ideal for a scientist with a strong track record in analytical and process development, who thrives in a fast-paced, dynamic environment and is excited to drive innovation in cell therapy analytics. Responsibilities Develop and adapt analytical methods for cell therapy product release and characterization by designing and executing studies using Design of Experiments (DoE). Design and execute exploratory experiments to define critical quality attributes (CQAs) and optimize existing analytical methods. Independently research, plan, and perform experiments, analyze data, and recommend next steps to internal and cross-departmental stakeholders. Perform risk and gap assessments for analytical methods to enhance compliance, robustness, and overall method reliability. Execute routine laboratory experiments in collaboration with junior technical staff, ensuring generation of high-quality data through best practices in assay and instrument operation. Perform detailed data analysis, document study outcomes and conclusions, and summarize and present findings to key stakeholders. Design, execute, and approve method development, transfer, and qualification activities in support of process development, product characterization, product release, and stability programs. Lead lifecycle management of analytical assays by trending data, assigning appropriate controls, and maintaining assay performance over time. Author standard operating procedures (SOPs), assay development and qualification reports, and sections of regulatory documents related to analytical methods. Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings. Collaborate with cross-functional teams to advance the development of cell therapy products. Support the training and mentorship of junior Research Associates and other team members as needed. Manage multiple projects in parallel, including key participation in multi-disciplinary project teams. Apply critical thinking, troubleshooting, and problem-solving skills to resolve complex analytical and technical challenges. Maintain strong attention to safety, good laboratory practice (GLP), and good documentation practice (GDP) in all activities. Essential Skills Master’s degree with 6–9 years of experience in analytical development, quality control (QC), technology transfer, and method lifecycle management, or a Ph.D. in Immunology, Molecular Biology, Biochemistry, or a related scientific discipline with at least 2 years of industry experience. Expertise in flow cytometry and immunology, including analytical method development and method transfer to QC laboratories. Demonstrated leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies, and method qualification/validation. Proficiency in experimental design, data analysis, control charts, and capability assessments using Design of Experiments (DoE). Ability to interpret and apply ICH guidances, cGMP, USP, and relevant regulatory requirements, as well as industry best practices for analytical method development, technology transfer, method qualification/validation, and process development. Comfort working in a fast-paced environment with minimal direction and the ability to adjust workload based on changing priorities. Excellent interpersonal, verbal, and written communication skills. Self-motivated and detail-oriented, with a willingness to take on responsibilities beyond the initial job description. Ability to manage multiple projects concurrently and contribute effectively to multi-disciplinary project teams. Strong critical thinking abilities, with demonstrated troubleshooting and problem-solving skills. Consistent attention to safety, good laboratory practice, and good documentation practice. Additional Skills & Qualifications Two or more years of relevant cell therapy industry experience. Experience with analytical control systems for stem cell and T cell products. Ex #J-18808-Ljbffr 6AM City, LLC