Senior / Principal Scientist, CMC Analytical Development

Summary:

In this role, you will own analytical development for potency, mechanism of action, product characterization, and release testing methods supporting early- and late-stage cell therapy programs. You will also author CMC analytical content for BLA submissions and help prepare our programs for commercialization. The ideal candidate is a hands-on, seasoned scientist with strong flow cytometry and cell-based assay expertise, experience taking methods through validation and transfer, and a track record of working closely with Process Development, Manufacturing, QC, and Quality.

Key Responsibilities

Method Development, Validation & Transfer

• Develop and optimize multiparametric flow cytometry and cell-based functional assays for cell therapy products.
• Lead validation of analytical methods for release and stability testing, including writing and reviewing protocols and reports.
• Drive method transfers between sending and receiving labs, including the overall transfer plan, protocols, execution of transfer testing, and reports.

Characterization, Potency & Mechanism of Action

• Perform extended characterization of product, including biological activity, potency, and mechanism of action studies.
• Support analytical comparability and product stability studies.
• Interpret experimental results and perform data analysis using appropriate software.
• Serve as subject matter expert for one or more analytical technologies such as flow cytometry, bioassays, cell counting, particle testing, or potency methods.

Regulatory & Commercialization

• Author CMC analytical content for BLA submissions and commercial launch preparation, including specifications, method development and validation, potency and mechanism of action studies, comparability, and stability.
• Author and review protocols, technical reports, method SOPs, and regulatory submission sections.

Collaboration & Communication

• Partner with Process Development, Manufacturing, QC, QA and other teams.
• Prepare and present data summaries and project updates to stakeholders and at cross-functional team meetings.

Required Qualifications

Education & Experience

• PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, or a related field with 5-8+ years of relevant industry experience.
• M.S. candidates may be considered with an outstanding track record in analytical development and the drug product process development.

Technical Expertise and Core Skills

• Substantial expertise in flow cytometry and cell-based assay technologies.
• Experience with immune functional assays in cell therapy and/or biologics analytical development or quality control laboratories.
• Working knowledge of QC and cGMP requirements for the biopharmaceutical industry, including relevant USP methodologies and ICH guidelines.
• Experience working with and leading cross-functional teams, such as CMC and clinical development teams.
• Strong written and verbal communication skills.
• Self-starter with strong interpersonal, planning, and tracking skills.
• Ability to manage multiple competing priorities in a fast-paced, changing environment.

Preferred Qualifications:

• History with commercialization projects and a successful track record of BLA or IND authorship.
• Experience in cGMP cell therapy and/or biological product manufacturing, particularly with immunological systems, cell therapy, gene therapy, or individualized patient therapies.
• Expertise in flow cytometry assay development and validation