Senior Process Engineer

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 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

Additional Information

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. 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, 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. 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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