Associate I, Manufacturing

Role Summary

Our 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. 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.

Responsibilities

• Learn and execute Cell Therapy Manufacturing operations
• Perform patient process unit operations and complies with operations described in standard operating procedures and batch records
• Executes transactions and process in all electronic systems
• Prioritizes safety of self and others
• Reports safety events within 24 hours
• Escalates any/all issues that may impact safety of self and/or others.
• Complete documentation required by governing controlled documents and batch records
• Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Complete training assignments to ensure necessary technical skills and knowledge
• Train for proficiency in process systems and some supporting business systems
• Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts
• 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
• Continues to refine and improve manufacturing process technique to improve individual operational times.
• Ensures training completion prior to production

Qualifications

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

Skills

• Safety-conscious and quality-driven mindset
• Ability to work across multiple shifts and adapt to changing priorities
• Team collaboration and communication
• Proficiency with standard operating procedures and batch records

Additional Requirements

• 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, which require gowning and PPE
• Required to carry and/or lift up to 30 pounds / 15 kg, several times a day; push/pull up to 50 pounds / 25 kg
• Work in areas that may have strong magnets; BSL2 / ML1 environment handling human blood components; exposure to vapor phase liquid nitrogen
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)