Responsibilities

• Lead the transfer of cell therapy analytical methods to QC from internal Cellares AD or directly from customers
• Evaluate analytical methods for feasibility, method improvement, remediation, and/or troubleshooting
• Support analytical method transfer and trending with statistical analysis
• Responsible for the authoring, review, approval, and oversight of analytical method procedures, method development reports, method validation, training/transfer protocols and reports for internal and external analytical methods
• Contribute to authoring of regulatory submissions
• Leads continuous cGMP analytical improvement projects. This includes, but may not be limited to, constant state of validation, improvement of methods and sustaining compliance with global requirements
• Work as the MSAT Analytical Transfer representative on client projects
• Prepare and present data associated with QC processes to internal and external clients
• Define and provide user requirements for QC equipment for the testing of manufactured cell therapies
• Work with our software team on integration solutions for the QC process and data management, including MES, QMS, and LIMS
• Provide technical leadership to QC and other departments associated with GMP QC operations
• Accountable to comply with GxP regulations, guidelines, procedures, and practices governing analytical methods for release and stability testing. Collaborate with internal and external groups cross-functionally as a subject matter expert to ensure compliance, OOS/OOE/OOT investigations, deviations, change controls and CAPAs
• Provide input when troubleshooting processes on the QC floor
• Additional duties as assigned

Requirements

• Bachelor’s degree in science, engineering, or related field required
• 4+ years experience in biologics/gene therapy with a primary focus on analytical method testing and/or transfer for cell therapy products. CDMO experience is a plus
• Knowledge of QC principles, concepts, industry practices, and standards
• Knowledge of and experience in relevant cell therapy characterization analytical methods including flow cytometry, ELISA, cell based assays, qPCR and ddPCR
• Exposure to one or more advanced potency methods, such as cytotoxicity or cytokine characterization
• Understanding of analytical transfer, qualification, and validation, and statistical methods
• Experience writing, reviewing and approving GMP documentation
• Understanding of cGMP and regulations/guidance, can interpret guidance documents and make technical recommendations. (QbD, ICH Validation of analytical procedures, FDA regulations)
• Excellent oral and written communication skills to effectively communicate with internal/external stakeholders, and to author technical documents (protocols, reports, SOP’s, investigations, deviations, CAPAs, regulatory filings)
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
• Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
• Self-motivated and passionate about advancing the field of cell therapy
• Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines
• Self-awareness, integrity, authenticity, and a growth mindset