Senior Process Engineer

3 weeks ago

San Francisco, United States Cellares Full time
Position Summary
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 and 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.
Candidates 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
  • Author assay qualification protocols and training QC team for protocol execution 
  • 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 - reports, method validation, training and tech transfer protocols and reports for internal and external analytical methods
  • Participate and contribute towards regulatory submissions
  • Lead 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 Specialist 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 the 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
  • Collaborate and work effectively with other MSAT groups, as well as other departments such as QC, QA, AD colleagues, to investigate and troubleshoot the  manufacturing process
  • 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


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 company’s 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.

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