Position Summary
We are seeking an innovative and highly motivated Staff 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 cGMP manufacturing, as well as drive and develop process automation to improve process reliability, safety, cost-effectiveness, scalability, and compliance. The individual will also be responsible for shop floor support and serve as a subject matter expert (SME) for all aspects of the manufacturing process.
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
- Translate client needs into requirements and project plans
- Responsible for technology transfer activities at the site level (within, inbound, and outbound), including any scale-up or other process adaptations
- Lead and/or support late stage process development activities including characterization, comparability, and qualification/validation activities
- Own the technology transfer from Process Development to cGMP Manufacturing operations - author the change record, draft/review/approve SOPs and batch records, train manufacturing personnel
- Support development of manufacturing operations and business processes, including GMP system implementation and tasks related to GMP readiness
- Support labor and equipment capacity modeling and participate in sales and operations planning process (S&OP) for supply review
- Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
- Provide user needs, requirements, and support implementation and UAT of Cellares software solutions (in-house or enterprise)
- Own root cause investigations and train manufacturing personnel to support robust root cause analysis. Facilitate complex cross-functional investigations
- Propose and implement corrective and preventive actions (CAPAs) as necessary and own respective effectiveness checks to ensure recurrence was prevented
- 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
- 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 11+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
- Experience with technology transfer in the Pharma/Biotech industry
- 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
- Excellent planning, organization, technical writing, and time-management skills, including the ability to support, problem-solve, and prioritize multiple projects and deadlines
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.
Top Skills
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.
