Cellares
Senior Process Engineer
Bridgewater, NJ · Senior
Sponsorship not specified$90k-$210kDetected 132 days ago
Customer SupportGMPCRISPRWriting
About the role
- 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.
- The successful candidate will be a resident expert in the areas of technology transfer and manufacturing science and technology.
Responsibilities
- Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies
- Lead Master Validation Plan creation in order to support PPQ campaigns
- 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 development and review of relevant SOPs for manufacturing operations and systems. Author and review global program policies Perform manufacturability assessments for new process introductions
- Provide technical support to Manufacturing and other departments associated with GMP operations
- Support or author product quality impact assessment for major deviations. 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
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
- Adherence to cGMPs is required all times during the manufacture of Cell Therapy products.
- Must have experience writing, reviewing and approving GMP documentation
- Support process development and process comparability activities on Cellares technology as required
Compensation
- $90k-$210k
Company info
- 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.
- Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers
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This listing is sourced directly from Cellares's careers page and normalized into a canonical job model.