Manufacturing Associate IV

Biogen•Research Triangle Park, NC

16d•$31 - $41•Onsite

About The Position

This role operates on a 2 2 3 schedule for Day Shift- 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 – Large Scale Cell Culture MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). 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) and at least 2 years of directly transferrable experience OR BioWork Certificate or Associate’s Degree + at least 2.5 year of directly transferrable experience OR High School Diploma (or equivalent) plus at least 3 years 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

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