Manufacturing Associate

About This Role

The Manufacturing Associate will operate biopharmaceutical manufacturing equipment and processes, contribute to process optimization and technical documentation, and ensure quality and compliance within cGMP environments.

Responsibilities

• Operate and understand biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance
• Support initiatives for process optimization
• Identify and elevate processing issues and support solutions
• Provide feedback and/or suggested changes to operational procedures
• Assist in the incorporation of new technologies, practices, and standards into procedures
• Write and review process documents
• Utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
• Participate on projects and contribute to outcomes
• Support new business systems (Track wise, ERP, etc.)
• Support trending of defined department metrics

Requirements

• Bachelor’s degree in science related area or engineering
• OR Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
• Strong communication skills—verbal and written
• Ability to work in a team environment
• Good conflict resolution and collaboration skills
• Displays good initiative to identify areas for improvement and implement solutions

Qualifications

• Bachelor’s degree in science related area or engineering OR Associate’s degree in science related area or Biotech certificate
• 2+ years of experience in a biotech manufacturing environment or other regulated industry if holding only an Associate's degree or Biotech certificate.

Skills

* Required skills