Manufacturing Associate II

BiogenResearch Triangle Park, NC
Onsite

About The Position

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (Days) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on Days (5:45 AM - 6 PM ET). 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 Formulation/Fill Finish. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Upstream / Cell Culture: Mammalian cell culture & harvest: Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L. Performing thaws and splits utilizing Aseptic technique.

Requirements

  • Bachelor’s degree, BioWorks Certificate, or associate’s degree from an accredited college, university, or program
  • High School Diploma (or equivalent) and at minimum of 6 months of direct experience
  • Experience in cGMP manufacturing, biotech, or pharmaceutical operations
  • Ability to follow detailed procedures and uphold safety and compliance standards
  • Familiarity with operating production equipment and maintaining manufacturing documentation

Nice To Haves

  • Bachelor’s degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university
  • Strong communication skills and a team-oriented mindset

Responsibilities

  • Execute daily manufacturing activities by operating production equipment, performing process steps, and completing validation or qualification protocols in accordance with cGMP and Standard Operating Procedures (SOPs)
  • Document all manufacturing work accurately, including cGMP data, deviations, equipment usage, and processing details.
  • Create, revise, and maintain batch records, SLRs, equipment logbooks, and other key documentation
  • Support in-process sampling and analysis, including routine measurements such as pH, conductivity, protein concentration, osmolality, and cell counts
  • Maintain a clean, safe, and audit-ready workspace by following safety guidelines, good housekeeping practices, and compliance expectations
  • Collaborate as a reliable team member, showing up with focus, accountability, and a willingness to support teammates and shared goals
  • Participate in training and development, building your own capabilities while helping strengthen the skills and readiness of the team

Benefits

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
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