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Senior Process Engineer
2 months ago
We are seeking a highly skilled Senior Process Engineer to join our team at Cellares. As a key member of our MSAT team, you will play a critical role in the development of our advanced cell therapy manufacturing platform.
Key Responsibilities- Support the development, process transfer, compliance, and scalability of our manufacturing operations
- Lead and/or support late-stage process development activities, including characterization, comparability, and qualification/validation
- Own the technology transfer from Process Development to cGMP Manufacturing operations, including authoring change records, drafting/reviewing/approving SOPs and batch records, and training manufacturing personnel
- Support the development of manufacturing operations and business processes, including GMP system implementation and tasks related to GMP readiness
- 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
- Own root cause investigations and train manufacturing personnel to support robust root cause analysis
- Facilitate complex cross-functional investigations and propose and implement corrective and preventive actions (CAPAs) as necessary
- 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
- Bachelor's Degree in a scientific or related field
- 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
- Must have experience writing and reviewing GMP documentation
- Strong analytical, problem-solving, and critical thinking skills, with 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
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.
All displayed pay ranges are approximate, negotiable, and location dependent.
