Manufacturing Associate 5

FUJIFILM Diosynth Biotechnologies-posted 2 months ago
Holly Springs, NC
Merchant Wholesalers, Durable Goods
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This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

  • Key contributor in supporting the preparation for operational readiness related to bulk drug substance manufacturing.
  • Supporting projects related to commissioning and qualification of equipment, procedure review and/or creation, support onboarding of manufacturing staff, development or transfer of manufacturing business processes, new item creation, or single-use assembly transfer or design.
  • Adhere to strict safety protocols and contribute to culture of safety within the manufacturing environment.
  • Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control within a functional area, ensuring compliance with Standard operating procedures (SOPs) and cGMP regulations.
  • Oversee and/or perform in-process testing (pH, conductivity, visual inspection).
  • Execute validation protocols. Provide approval as a backup to the supervisor.
  • Maintain training to perform all required activities.
  • Train and mentor junior manufacturing associates to enhance team capabilities.
  • Support scheduling daily activities on the manufacturing floor and act as a back-up for the supervisor, as needed.
  • Lead troubleshooting as required for operational issues.
  • Assist the supervisor with shift huddles and tier escalations, investigation, and continuous improvement (CI) projects, as needed.
  • Area lead for cycle counts and materials management.
  • Other duties as assigned.
  • 8 Years of experience in life sciences manufacturing with a High School Diploma or GED OR
  • 6 Years of experience in life sciences manufacturing with an Associate's Degree OR
  • 4 Years of experience in life sciences manufacturing with a Bachelor's Degree OR
  • Equivalent Military Experience
  • Associate's Degree
  • BA/BS Degree, preferably in Life Sciences or Engineering
  • Proficient understanding of cGMP regulations and pharmaceutical industry standards
  • Fully qualified in a functional area (Ex: Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture or Purification) while also acting as an SME on all unit operations within that functional area (i.e. Inoc, Seed Train and Production Bioreactor)
  • BioWorks Certification
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