Senior Analytical Transfer Scientist

We are seeking a highly experienced Scientist or Senior Scientist to join our Analytical Sciences and Technology (ASAT) team, with a specific focus on cell and gene therapy. The ideal candidate will be responsible for leading the method transfer, optimization, and validation of analytical methods to support product characterization, quality control, and regulatory filings for cell and gene therapy products. This role requires extensive experience in advanced analytical techniques and a deep understanding of regulatory requirements for cell and gene therapy development. You will collaborate with cross-functional teams including Development teams, Automation teams, Quality Control, MSAT, and Manufacturing to ensure the robustness and regulatory compliance of all analytical strategies. The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. Responsibilities

• Analytical Method Transfer: Lead the transfer of analytical methods to internal or external Quality Control laboratories
• Author and review method transfer protocols and reports, and ensure adherence to GMP and regulatory guidelines
• Product Characterization and Testing: Execute advanced testing for the characterization of cell and gene therapy products, including potency assays, viral titer assays, and vector genome quantification

• Design and execute studies to support process development, stability testing, and comparability assessments
• Ensure alignment with FDA, EMA, and ICH regulatory expectations for cell and gene therapies
• Data Analysis and Reporting:
• Analyze complex data sets from bioanalytical assays, ensuring scientific integrity and reproducibility.
• Prepare technical reports, protocols, and analytical sections for regulatory submissions, including IND, BLA, and MAA filings.
• Regulatory Compliance: Ensure all analytical methods comply with current regulatory standards for cell and gene therapies, including cGMP, ICH, and FDA/EMA guidelines

• Support Regulatory Affairs by providing expert technical input during regulatory submissions and responding to regulatory inquiries.
• Cross-Functional Collaboration: Work closely with Development teams, MSAT, Manufacturing, and Quality Control teams to provide analytical support across all stages of product development

• Act as the analytical subject matter expert (SME) in cross-functional project teams, providing strategic guidance on analytical methods
• Innovation and Technology Evaluation: Stay abreast of the latest advancements in analytical technology, particularly those applicable to cell and gene therapy (e.g., next-generation sequencing, digital PCR)

• Evaluate and implement new tools, instruments, and methodologies that enhance the analytical capabilities of the ASAT team
• Cross-Functional Collaboration: Work closely with Development teams, MSAT, Manufacturing, and Quality Control teams to provide analytical support across all stages of product development

• Act as the analytical subject matter expert (SME) in cross-functional project teams, providing strategic guidance on analytical methods
• Innovation and Technology Evaluation: Stay abreast of the latest advancements in analytical technology, particularly those applicable to cell and gene therapy (e.g., next-generation sequencing, digital PCR)

• Evaluate and implement new tools, instruments, and methodologies that enhance the analytical capabilities of the ASAT team

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or a related field with 5+ years of relevant experience within cell and gene therapy in QC, MSAT/ASAT, or Analytical Development (Masters degree with 8+ years of experience or Bachelors degree with 10+ years of experience will be considered)
• Strong experience with analytical techniques used in cell and gene therapy, including qPCR/ddPCR, flow cytometry, cell-based potency assays, ELISA, and vector-based assays (AAV, lentivirus)
• Experience in method development, validation, and transfer for cell and gene therapy products
• Hands-on experience working under GMP conditions and supporting regulatory filings such as IND and BLA submissions
• Knowledge of product characterization requirements for viral vectors, gene-modified cells, and other advanced therapeutic products
• Excellent data analysis and interpretation skills with strong proficiency in analytical software (e.g., FlowJo, JMP, GraphPad Prism)
• Experience collaborating with cross-functional teams in a fast-paced, regulatory-driven environment
• Must be able to manage shifting priorities to meet critical deadlines.
• Strong analytical, problem-solving, and critical thinking skills, and the ability to lead as a change agent to promote flexibility, creativity, and accountability
• Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
• Excellent organizational and communication skills
• Self-motivated and passionate about advancing the field of cell therapy.
• Self-awareness, integrity, authenticity, and a growth mindset

Preferred Experience:

• Prior experience in cell therapy or gene therapy product development, including viral vector quantification and T cell-based assays
• Familiarity with regulatory requirements for cell and gene therapy products in GMP environments
• Knowledge of statistical analysis software and experience in the design of experiments (DoE) for method development

This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The companys Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.