Position Summary
We are seeking an innovative and highly motivated Senior Process Engineer on our MSAT team who will contribute significantly to the development of our advanced cell therapy manufacturing platform.
This position is responsible for supporting the activities involved in development, process transfers, compliance, and scalability for Cellares’ manufacturing operations. This individual will focus on technology transfers from Process Development into GMP manufacturing facilities, as well as driving and developing process automation and scalability solutions to improve process reliability, safety, cost-effectiveness, scalability, 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 technology transfer and manufacturing science and technology. 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
- Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies
- Work as the MSAT representative on client projects
- Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers
- Lead and drive technology adoption program initiatives, including ROI analyses with internal and external stakeholders
- Support development of manufacturing operations including GMP system implementation and tasks related to GMP readiness
- Support process development and process comparability activities on Cellares technology as required
- Develop and review relevant SOPs for manufacturing operations and systems
- Perform manufacturability assessments for new process introductions
- Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
- Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS
- Work with our software team to provide feedback on internal software solutions
- Provide technical leadership to Manufacturing and other departments associated with GMP operations
- Assess all major deviations including those that impact product quality. Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
- Maintain and report process run summaries, and continued process verification reports
- Prepare and present data associated with manufacturing processes to internal and external partners
- Support for process qualification and validation preparation, execution, and reporting
- Work with clients on process mapping of the manufacturing processes
- Other duties as assigned
Requirements
- Bachelor’s Degree in a scientific or related field is required
- A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
- Experience in the Pharma/Biotech industry in technology transfer
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site
- Adherence to cGMPs is required all times during the manufacture of Cell Therapy products. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions
- Relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plus
- Must have experience writing, reviewing and approving GMP documentation
- Self-motivated and passionate about advancing the field of cell therapy
- Self-awareness, integrity, authenticity, and a growth mindset
- Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
- Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines.
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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.
