Description
Position Summary
We are seeking an innovative and highly motivated Senior Process Engineer to join the MSAT team who will contribute significantly to the development of our advanced cell therapy manufacturing platform.
The primary focus of this position will be to support 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 clinical and commercial cGMP manufacturing, as well as drive and develop process automation to improve reliability, safety, cost-effectiveness, scalability, and compliance. The individual will also be responsible for direct shop floor support during technology transfers and serve as a subject matter expert (SME) for all aspects of the manufacturing process.
This is a multidisciplinary role & this individual will further interface across many parts of the company 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 achieved. This is a hands-on position.
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 and/or support 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 process characterization, comparability, and qualification/validation activities
- Own the technology transfer from Process Development to cGMP Manufacturing operations - author change controls, 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)
- Oversee 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
- 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 5+ 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 Direct experience writing and reviewing cGMP 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
- 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/entrepreneurial mindset
Preferred Skills/Experience
- Advanced degree (Masters, PhD) in a scientific or related field
- Experience with Operational Excellence and/or Lean Manufacturing
- Direct experience designing, executing, and supporting process characterization studies
- Direct experience performing root cause analysis and leading complex investigations
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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