Manufacturing Associate IV / V, Purification (Days) at External — Research Triangle Park, NC

About This Role

Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET)

Internal Shift Details: Red Days 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.

This role’s primary focus is Downstream (Purification):

• Column Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance

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, 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

Required Skills for a Manufacturing Associate IV: $31.25 - $40.87 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 at minimum 2 years of direct experience
• A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 years 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).
• Experience or understanding of working in an aseptic or cleanroom environment.
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.).
• Previous pipetting experience in a laboratory or manufacturing environment preferred.

Required Skills for a Manufacturing Associate V: $33.17 - $43.27 Pay Range

• Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience
• A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experience
• A High School Diploma (or equivalent) and at minimum of 5 years of direct experience
• Experience working in an aseptic or cleanroom environment.
• Problem solving, troubleshooting, and EBR experience preferred.
• CMMS and TrackWise experience preferred.

The base compensation range for this role is: $31.25-$43.27 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.

• 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?