We are seeking an innovative and highly motivated Process Engineer to join the 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 the development, process transfer, compliance, and scalability for Cellares’ manufacturing operations. This individual will focus on technology transfers from Process Development into GMP manufacturing facilities, from South San Francisco to other Cellares sites, as well as drive and develop process automation to improve process reliability, safety, cost-effectiveness, scalability, and compliance.
This is a multidisciplinary role requiring the ability to interface with internal and external stakeholders across functional areas 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 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
Own the process knowledge of the product(s) assigned throughout the development lifecycle, work collaboratively for comprehensive process mapping, maintain the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in a continued state of validation and continuously improving
Ensure the seamless flow of knowledge and information across functions, and with external stakeholders when applicable, with a focus on the assigned product(s)
Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across the manufacturing of cell therapies
Work as the MSAT Process Engineer on internal or client projects
Responsible for technology transfer activities at the site level (within, inbound, and outbound), including any scale-up or other process adaptations
Execute on technical transfer project team at site and liaises efficiently with involved internal and external functional groups as appropriate
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
Write and review relevant SOPs for manufacturing operations and systems, as well as batch records and BOMs
Support labor and equipment capacity modeling and participate in sales and operations planning process (S&OP) for supply review
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
Support our software team in developing a robust end-user solution for cell therapy manufacturing that integrations with external manufacturing processes and data management software including eBR, MES, QMS, ERP, and LIMS
Provide technical leadership to Manufacturing and other departments associated with GMP operations
Assess all major deviations including those that impact product quality
Ownership of root cause analysis investigations and discussions, including effectively liaising across the appropriate functional teams to drive resolution to major quality events and deviations
Propose and implement corrective and preventive actions (CAPAs) as necessary and own respective effectiveness checks to ensure recurrence was prevented
Ownership of process-related change controls and change orders, from ideation and change control board review to implementation and effectiveness check
Facilitate and/or own the generation of process or operational-related Failure Modes and Effects Analysis (FMEA) and resulting mitigations and actions
Develop training and onboarding content and curriculum for new hires and new methods
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, as well as health authority inspectors
Support for process qualification and validation preparation, execution, monitoring, and reporting
Work with clients on process mapping of the manufacturing processes
Requirements
Bachelor’s Degree in a scientific or related field is required
A minimum of 3+ 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 at all times during the manufacturing 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 and reviewing GMP documentation
Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
Experience with Operational Excellence and/or Lean Manufacturing is a plus
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 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
Skills Required
- Bachelor's Degree in a scientific or related field
- Minimum of 3+ years experience in biotech/biopharma cGMP operations (preferably cell and gene therapy)
- Experience in technology transfer within Pharma/Biotech
- Adherence to cGMPs and GMP readiness experience
- Must follow job safety procedures and attend health and safety training
- Experience writing and reviewing GMP documentation (SOPs, batch records, BOMs)
- Experience with root cause analysis, CAPA, change control, and handling major deviations
- Ability to perform data trending and statistical analysis of critical process variables
- Experience bringing biotechnology equipment and processes from design through GMP operational readiness
- Experience with Operational Excellence and/or Lean Manufacturing
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.
