Senior Analytical Transfer Specialist

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

Full Time