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Manufacturing Associate II / III - Media & Solution Preparation

External
Biogen logoBiogen · Research Triangle Park, NC
Full-timeOn-site1d ago
DocumentationSAFe
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Responsibilities

  • Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
  • Accurately document activities in accordance with cGMP and SOP requirements
  • 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
  • Collaborate cross-functionally with Manufacturing, MSAT, Quality, and Engineering teams

Requirements

  • 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 0 years of direct experience
  • A BioWorks Certificate and/or associate's degree, STEM preferred and 0 years of direct experience
  • A High School Diploma (or equivalent) and at minimum .5 years of direct experience
  • Previous experience in a cGMP environment desired
  • Ability to follow SOPs and work effectively on shift schedules if required
  • Demonstrated documentation and data integrity skills
  • Understanding of aseptic technique and cleanroom practices is preferred
  • Required Skills for a Manufacturing Associate III: $25.96 - $34.13 Pay Range
  • Bachelor's degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
  • A BioWorks Certificate and/or associate's degree, STEM preferred and at minimum 1 year of direct experience
  • A High School Diploma (or equivalent) and at minimum 1.5 years of direct experience
  • Previous experience in a cGMP environment
  • Knowledge of aseptic technique and cleanroom practices
  • Exposure to Delta V, Syncade, or similar systems
  • Job Level: Entry Level
  • Additional Information
  • The base compensation range for this role is: $23.56-$34.13
  • Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
  • 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.
  • In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
  • 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
  • Why Biogen?
  • We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-si

Benefits

Dental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonusParental leave

Additional Information

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 days (6:00 PM - 6:00 AM ET) Internal Shift Details: Red Day 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 on Media & Solution Preparation operations.


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