As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.

Specific Responsibilities

• Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
• Complete training sessions and ensure training documentation is maintained.
• Understands and complies with quality standards and requirements as documented.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Supports technical transfer and additional research level testing activities.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.

Job Types: Full-time, Contract

Pay: From $26.00 per hour

Schedule:

• 10 hour shift
• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Research: 1 year (Preferred)
• Cell culture: 1 year (Preferred)
• Cell biology: 1 year (Preferred)

Work Location: In person