Manufacturing Associate III / IV, Purification (Nights)

About This Role

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.

Shift Details: This role follows a 2-2-3 calendar rotation on nights (6:00 PM – 6:00 AM ET)

Internal Shift Details: Black Nights rotating schedule

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them.

Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).

This role’s primary focus is Downstream (Purification):

• Column Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance

What You’ll Do

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Document and record all cGMP data & information (including deviations) for processing steps and equipment activities
• Create and revise key documentation like batch records, SLRs, and equipment logbooks
• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, etc.)
• Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
• Be a team player and leader; always showing up to contribute your energy and focus
• Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Who You Are

You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.

Required Skills for a Manufacturing Associate III: $25.96 - $34.13 Pay Range

• The following combination of academic and/or relevant experience may be considered:
  • Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
  • A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
• Previous experience in a cGMP environment.
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP).
• Experience or understanding of working in an aseptic or cleanroom environment.
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.).
• Previous pipetting experience in a laboratory or manufacturing environment preferred.

Required Skills for a Manufacturing Associate IV: $31.25 - $40.87 Pay Range

• The following combination of academic and/or relevant experience may be considered:
  • Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience
  • A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
• Previous experience in a cGMP environment.
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP).
• Experience working in an aseptic or cleanroom environment.
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.).
• Previous pipetting experience in a laboratory or manufacturing environment preferred.