Manufacturing Associate II​/III, Purification

Position: Manufacturing Associate II / III, Purification (Days)
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 AM – 6:00 PM ET)
Internal Shift Details:
Black Days 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 DoExecute 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 II: $23.56 - $30.77 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 0+ years of direct experienceA Bio Works Certificate or associate's degree, STEM preferred and at minimum 0+ year of direct experienceA High School Diploma (or equivalent) and at minimum of .5 years of direct experience

Previous experience in a GxP environment

Ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP) Understanding of working in an aseptic or cleanroom environment is preferred

Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)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 experienceA Bio Works Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experienceA 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 is…