Senior Associate II Manufacturing, Cell Therapy

Position Summary

BMS Cell Therapy Manufacturing is seeking enthusiastic and passionate Senior Manufacturing Associates to join the Manufacturing team. Our Senior Manufacturing Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. The Senior Manufacturing Associate is a SME on complex manufacturing unit operations and complex business processes. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

Duties/Responsibilities:

• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Demonstrate strong practical and theoretical knowledge in their work
• Complete documentation required by governing controlled documents and batch records
• SME on complex manufacturing unit operations and complex business processes
• SME on supporting processes
• Complies with Source Governing Documents (SGDs)
• Solve complex problems; takes new perspectives using existing solutions
• Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Complete training assignments to ensure the necessary technical skills and knowledge
• Proficient in process systems and supporting business systems
• Train and qualify others on processes, SOPs, Work Instructions to successfully complete manufacturing operations
• Completes Notice of Events, Minor deviations and supports and leads investigations, as required
• Works to identify innovative, continuous improvement solutions
• Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
• Author, review, approve as needed manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Partner with production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts
• Drive Right First Time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
• Aid in daily work coordination and distribution as demanded through the production schedule
• Responsible for maintaining schedule adherence and cycle time. Report variances and communicate impact to cross functional groups and Team Leads
• Ensure shift notes communications are complete and accurate
• Work in a controlled cleanroom environment and execute aseptic processing procedures (as needed). Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
• Completes change actions and MRB slides as needed or assigned
• Have a positive attitude and cultures this in the team and department.

Education/Experience/ Licenses/Certifications:

• MBO 3 of 4 in science related field and/or equivalent
• 7+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired
• Demonstrated aptitude for engineering principles and manufacturing systems
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications
• Demonstrated good interpersonal skills, is attentive and approachable
• Maintain a professional and productive relationship with area management and co-workers

Preferred Experience:
• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Cell expansion using incubators and single use bioreactors

Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.