Manufacturing Associate II

Biogen•Research Triangle Park, NC

1d•Onsite

About The Position

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

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