Clinical Manufacturing Associate

Responsibilities

• Production of blood component lots through cell culture, harvest, and cryopreservation.
• Become fully trained and qualified in all aspects of assigned processes.
• Develop a high level of technical knowledge of project(s).
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time, internal production logistics.
• Record production data and information in a clear, concise format according to GDPs.
• Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
• Assist tech transfers in and out of the clinical facility.
• No direct reports will be assigned to this job role.
• Perform other tasks as assigned.

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Experience with in a cGMP/FDA-regulated industry.
• Basic mathematical skills.
• Technical writing capability.
• Proficient in MS Office applications.
• Background to include an understanding and application within industry of biology, chemistry, medical or clinical practices.
• Advanced understanding of cell culture (preferred).
• Bachelor’s degree in an applicable science OR 2 years relevant experience.

• Location:
  
  Onsite in Warren.
• Work Schedule:
  
  Friday–Tuesday, 8:30 AM–5:00 PM.
• Role type:
  Contract assignment.