Manufacturing Associate II / III, Purification (Days)

Biogen•Research Triangle Park, NC

1d•Onsite

About The Position

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

Requirements

Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 0+ years of direct experience (for Associate II)
A BioWorks Certificate or associate's degree, STEM preferred and at minimum 0+ year of direct experience (for Associate II)
A High School Diploma (or equivalent) and at minimum of .5 years of direct experience (for Associate II)
Previous experience in a GxP environment (for Associate II)
Ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP) (for Associate II)
Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience (for Associate III)
A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience (for Associate III)
A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience (for Associate III)
Previous experience in a cGMP environment (for Associate III)
Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP) (for Associate III)

Nice To Haves

Understanding of working in an aseptic or cleanroom environment is preferred (for Associate II)
Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.) (for Associate II)
Experience or understanding of working in an aseptic or cleanroom environment (for Associate III)
Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.) (for Associate III)
Previous pipetting experience in a laboratory or manufacturing environment is preferred (for Associate III)

Responsibilities

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