Senior Process Engineer
3 days ago
We are seeking a highly skilled Senior Process Engineer to join our MSAT team at Cellares. As a key member of our team, you will play a crucial role in the development of our advanced cell therapy manufacturing platform.
Key Responsibilities- Support the development of manufacturing operations, including GMP system implementation and tasks related to GMP readiness.
- Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers.
- Develop and review relevant SOPs for manufacturing operations and systems.
- 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.
- Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS.
- Provide technical leadership to Manufacturing and other departments associated with GMP operations.
- Assess all major deviations including those that impact product quality.
- 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.
- Adherence to cGMPs is required all times during the manufacture of Cell Therapy products.
Cellares offers a competitive total compensation package, including a base salary range of $90,000 - $210,000 per year, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
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