Manufacturing Associate IV, OSM/OPM (ASO) (Days)

Biogen•Research Triangle Park, NC

1d•$31 - $41•Onsite

About The Position

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Product 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. This role’s primary focus is on upstream and downstream of ASO (antisense oligonucleotides). Shift Details: Monday-Thursday 6 am to 4 pm There may be an occasional need for Friday and after-hours support

Requirements

Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience
A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
Previous experience in a cGMP environment
Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
Understanding process automation and software systems (e.g. LIMS)
Ability to climb ladders, work in tight spaces, and lift/move equipment up to 50 lbs.
Must be comfortable working in cleanroom environments with required gowning and able to stand for up to 3 hours at a time.

Responsibilities

Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
Perform and monitor critical upstream processes and troubleshoot operational and equipment problems
Execute upstream and downstream ASO manufacturing operations in a cGMP-regulated environment, ensuring adherence to batch records, standard operating procedures, and production schedules
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
Perform in-process sampling and sampling analysis (e.g., pH, Osmolarity,)
Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
Actively participate 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