Manufacturing Associate III
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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
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
- The following combination of academic and/or relevant experience may be considered:
- The following combination of academic and/or relevant experience may be considered: Bachelor's degree and 6 months of direct experience
- BioWorks Certificate, or associate's degree from an accredited college, university, or program and minimum of 1 year of direct experience
- High School Diploma (or equivalent) and at minimum of 1.5 years 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
- Preferred Skills
- Bachelor's degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university
- Strong communication skills and a team-oriented mindset
- Job Level: Entry Level
- Additional Information
- The base compensation range for this role is: -
- 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?
Benefits
Additional Information
About This Role Our factories run a basic 4-10 Mon - Thurs model with the necessity to be flexibility. Our manufacturing teams work 6am - 4pm with daily flexibility needed as well. Shift Details: This role has our manufacturing teams work 6am - 4pm with daily flexibility needed as well. 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 (Synthesis), Downstream (Purification), and Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Upstream / Synthesis: Buffer weigh outs Amedite preparation Synthesis operation using Unicorn operating system Downstream / Purification: Column Chromatography Detritalization Ultra-Filtration Bulk Dispensing of the drug substance
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