Principal Scientist, Analytical Development, Cell Therapy

Role Summary

We are looking a highly motivated and self-driven professional to join our Cell Therapy Analytical Development (CTAD) department as a Senior or Principal Scientist. The successful candidate will play a crucial role in developing, validating, transferring, and troubleshooting plate-based assays to advance cell therapy development deliverables. The Senior/Principal Scientist will design and analyze experiments with minimal supervision, leading to the development of robust analytical methods. They will be responsible for developing QC methods for lot release testing, characterization methods for product understanding, and routine testing to support process development and comparability assessments.

Responsibilities

• Act as subject matter expert to develop, optimize, validate, and troubleshoot assays used for vector and cell therapy products.
• Design and execute phase appropriate validation, and manage method transfer from CTAD to internal or external QC/testing groups.
• Maintain meticulous laboratory notebooks and manage routine sample analysis requests.
• Represent the group and present data to cross functional meetings.
• Author, review and approve technical documents, including methods, protocols, reports, and regulatory submissions.
• Good knowledge of cGMP and ICH/FDA/EMEA guidance.
• Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.
• Complete regulatory, site, and department training requirements on a timely basis.

Qualifications

• A PhD with 5+ (BS with 12+) years of experience in pharmaceutical research, development, or related industry experience.
• In-depth knowledge and hands-on experience in development and validation of ligand binding assays (e.g., ELISA, MSD, AlphaLISA, Simple Plex, Luminex).
• Proven experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, MSD Workbench, Excel).
• Ability to work effectively in a collaborative team setting and in a rapidly changing environment with frequent changes in priorities, which require strong organizational skills.
• Strong written and oral communication skills.
• Experience in cGMP environment is a preferred.

Skills

• Ligand binding/antibody assay development
• Data analysis and interpretation
• Collaborative teamwork and communication
• cGMP compliance and regulatory guidance awareness