Manufacturing Associate I

Duties and Responsibilities

• Learn and execute Cell Therapy Manufacturing operations compliantly
• Execute operations as outlined in Source Governing Documents (SOPs, Work Instructions, Batch Records, Forms)
• Execute transactions and processes in all electronic systems and adhere to business continuity processes
• Prioritize safety of self and others; report safety events within 24 hours
• Immediately escalate any/all issues that may impact compliance or safety
• Complete documentation required by Source Governing Documents contemporaneously
• Perform all tasks consistent with safety policies, SOPs, quality systems, and GMP requirements including ALCOA+
• Complete training assignments prior to assigned due date
• Train for proficiency in process systems and some supporting business systems
• Execute the daily unit operations schedule including people, product, and material flow across multiple shifts
• Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned)
• Maintain manufacturing environmental conditions by performing area disinfection regimen
• Continually refine and improve manufacturing process technique to improve individual operational times
• Verify training completion prior to performing any GxP tasks
• Author Manufacturing operating procedures that are technically sound and comply with cGMP requirements

Education

• Associate or bachelor's degree in related field is preferred
• A minimum high school diploma and/or equivalent combination of education and experience is required

Experience

• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• Proven experience working on teams where collaboration and results were expected
• Proficiency in common computer tools such as word processing, spreadsheet and web-based applications
• Meticulous attention to detail and personal accountability is critical to success
• Possess excellent interpersonal skills, is attentive and approachable
• Maintain a professional and productive relationship with area management and co-workers
• Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred

Working Conditions

• Must be able to stand/walk for extended periods of time
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets, requiring gowning and PPE
• Required to carry and/or lift up to 30 pounds / 15 kg several times a day
• Required to push and/or pull up to 50 pounds / 25 kg several times a day
• Work in areas that may have strong magnets
• Must be able to work in a BSL2 / ML1 work environment handling human blood components
• Work in areas with exposure to vapor phase liquid nitrogen
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)