Position Summary
We are seeking an innovative and highly motivated MSAT Senior Analytical Transfer Specialist who will contribute significantly to the development of our advanced cell therapy manufacturing platform.
This position is responsible for supporting the activities involved in analytical process transfers, compliance, and scalability for Cellares’ Quality Control (QC) operations. This individual will focus on technology transfers from Analytical Development (AD) to support ongoing GMP QC operations, as well as driving and developing assay automation and scalability solutions to improve reliability, safety, cost-effectiveness, and compliance.
This is a multidisciplinary role & this individual will interface across many parts of the company (with customers, scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be a resident expert in the areas of analytical transfer. It is expected that this individual will work closely with other corporate functional areas and partners to ensure deliverables are met.
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
- 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-awareness, integrity, authenticity, and a growth mindset
- 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
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
