Specialist, Lead Manufacturing Associate, Cell Therapy - Nights

Role Summary

Specialist, Lead Manufacturing Associate, Cell Therapy - Nights. Lead Manufacturing Associate supervises the shift for manufacturing of human blood derived components in a cGMP cleanroom, supports deviations and investigations, and serves as a qualified trainer for all buckets of operation. Works with the Quad Manager to ensure production goals and compliance are met on a Sunday-Wednesday overnight shift.

Responsibilities

• Production of blood component lots for one CAR-T bucket of operations
• Cross trained in all other buckets of operations (based on availability and business need)
• Provide training and guidance to manufacturing associates as required
• Aseptic technique is required for most activities (tube welding, connections, transfers)
• Aseptic qualification required per bucket
• Weigh and measure in-process materials to ensure proper quantities are added/removed
• Perform and oversee process unit operations described in SOPs and batch records
• Complete and review documentation required by transfer protocols, validation protocols, SOPs, and batch records
• Assist Manager to ensure the shift adheres to safety policies, quality systems, and GMP requirements
• Serve as a qualified trainer to maintain shift qualification standard
• Support deviation investigations and on-time closure of deviations and CAPAs
• Schedule daily unit operations across multiple shifts
• Ensure associates execute scheduled activities on-time per production schedule
• Ensure batch records for production data are clear and concise per GDPs
• Foster a team-based, cross-functional shift environment to complete tasks
• Collaborate with Managers to communicate operational status
• Other duties as necessary
• No direct reports will be assigned

Qualifications

• Master's Degree and 2 years of Manufacturing or Operations Experience or Bachelor's degree and 4 years of Manufacturing or Operations experience or Associate/Medical Technical degree and 8 years of Manufacturing or Operations experience or High School diploma/GED and 10 years of Manufacturing or Operations experience
• Thorough understanding of media production (if applicable), cell culture, selection/isolation, activation/initiation, transduction, debead (if applicable), expansion, harvest and cryopreservation for CAR-T
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Basic mathematical skills
• Full compliance with Good Documentation Practices
• Technical writing capability
• Proficient in MS Office applications
• Proficient in BMS Business Applications including Syncade/MES/Oracle, EQRMS/Infinity, Cellabs
• Background in biology, chemistry, medical or clinical practices
• Experience in aseptic processing in ISO 5 cabinets, handling human-derived materials in BSL-2, cell expansion, cell washing, cell separation, or cryopreservation processes and equipment
• Ability to work assigned shift (Day, Night, Weekends and/or Holidays)
• Experience as a trainer for GMP manufacturing processes

Skills

• Strong communication and training skills
• Good documentation and record-keeping abilities
• Effective collaboration within cross-functional teams
• Technical proficiency with manufacturing systems and tools

Education

• Master's Degree in Manufacturing/Operations or related field, or Bachelor's degree in related field, or Associate/Medical Technical degree, or High School diploma/GED with equivalent experience

Additional Requirements

• Intermittent walking, standing and sitting; ability to stand for extended periods
• Comfort working with contained human blood components
• Physical dexterity for computers and documentation
• Vision and hearing capabilities suitable for job environment
• Ability to lift up to 25 pounds
• Work in laboratories and controlled, enclosed, restricted areas; proximity to strong magnets
• Cleanroom garments and PPE required in designated areas
• Restricted areas with limited outside materials; no work-from-home for this role