We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. We are seeking a Specialist, Manufacturing Execution System to implement and support the Manufacturing Execution System (MES) and electronic Master Batch Records (MBRs) strategy.
Requirements
- BA/BSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 5 years’ experience
- MBA or MSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 3 years’ experience
- Minimum 2 years’ experience in GMP manufacturing and operations experience with emphasis on MES deployment
- Experience in Manufacturing Execution Systems primarily in having designed and created best practice MBRs
- Experience with Process Equipment and Process Automation Systems in MES context
- Experience in cell therapy or biologics manufacturing unit operations such as cell processing, aseptic processing, fill/finish
- Demonstrated experience implementing software systems and performing tasks in a regulated or pharmaceutical production environment
- Excellent communication, technical writing, and project management
- Deep Master Batch Record and manufacturing document design expertise demonstrated with formal training and experience
- Core Computer IT Skills and capability to learn advanced IT
- Thorough understanding of Master Data in MES Context, ability to define and manage master data working with a cross-functional team from Manufacturing, Quality, and Supply Chain
- Understanding of ERP, LIMS, data historian, and other common manufacturing-related IT Systems and integration requirements with MES systems is highly preferred
Benefits
- Subsidized medical, dental and vision plans
- FSA
- Company provided Life and AD&D Insurance
- STD and LTD Insurance
- ESPP
- 401(k) Plan with Company match
- Mass transit commuter benefits
- Cell phone reimbursement
- Paid time-off benefits (18 days’ vacation, 9 day’s sick leave, 8 observed holidays, and a floating holiday)
- Summer and winter office shutdown
