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.
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