Manufacturing Associate III

BiogenResearch Triangle Park, NC
$24 - $31Onsite

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. This role is a day shift position on a 2 2 3 rotation-6a-6p About This Role 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. MAs 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 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, Cell Counts, 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 are someone with a deep passion for doing work that furthers a mission to save lives. Biomanufacturing is complex, so you have a high degree of demonstrated learning agility and love a fast-paced work environment where everything you do is incredibly impactful.

Requirements

  • Bachelor’s Degree (STEM preferred) OR BioWork Certificate or Associate’s Degree
  • High School Diploma (or equivalent) plus at least 6 months of direct and/or military experience

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, Cell Counts, 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

Benefits

  • Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
  • 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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