Manufacturing Associate

Responsibilities

• Understand process theory and equipment operation in biopharmaceutical manufacturing, including:
  • Mammalian cell culture
  • Depth filtration
  • Tangential flow filtration
  • Column chromatography
  • Centrifugation
  • Protein purification
  • Formulation of bulk drug substance
• Support initiatives for process optimization and identify/elevate processing issues to help develop solutions.
• Gain experience with automation systems (LIMS, MES, PI, etc.).
• Provide feedback and suggested changes to operational procedures and assist in incorporating new technologies, practices, and standards.
• Write and review process documents.
• Apply understanding of cGMPs as related to Commercial Operations and utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Participate in projects and contribute to outcomes, including learning and supporting new business systems (TrackWise, ERP, etc.).
• Support trending of defined department metrics.

Work Environment & Physical Demands

• Consists of strenuous, repetitive work involving daily physical movements such as bending, reaching, climbing stairs and ladders, kneeling, and making numerous equipment connections using hands.
• Independently lift, dispense, push, and/or pull items with an average weight of 25 pounds.
• Work around loud equipment and use personal protective equipment (PPE).

Skills

• Strong verbal and written communication skills.
• Ability to work in a team environment, including conflict resolution and collaboration.
• Displays initiative to identify areas for improvement and implement solutions.

Qualifications

• Bachelor’s degree in a science-related area or engineering, or
• Associate’s degree in a science-related area or Biotech certificate with 2 years of experience in a biotech manufacturing environment or other regulated industry.

Schedule

Sunday–Tuesday with alternating Saturdays, 6:00 PM – 7:00 AM.