Bioprocess Manufacturing Associate IV

Biogen; North Carolina; On-site; USD 43,000 - 56,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness reimbursement

Disability insurance

Vacation and holidays

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen in Research Triangle Park (RTP), NC, is seeking a Manufacturing Associate IV to execute daily manufacturing steps, operate process equipment, and ensure cGMP compliance in our Drug Product facility. This role focuses on upstream/downstream operations, in-process sampling (pH, osmolarity), documentation of batch records, and maintaining an audit-ready, cleanroom environment.

Shift: Mon–Thu 6 am–4 pm with occasional Friday and after-hours support; base pay range $31.25–$40.87 per hour, with

Qualifications

• Bachelor's degree from an accredited college or university, STEM preferred, and at minimum 2 years of direct experience.
• BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience.
• 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).

Responsibilities

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP 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, SOPs, 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

Skills

SOP adherence

GDP adherence

Problem solving

Learning agility

Education

Bachelor's degree STEM

BioWorks Certificate/associate degree

High School Diploma + 3 years experience

Tools

LIMS

Job description

Biogen in Research Triangle Park (RTP), NC, is seeking a Manufacturing Associate IV to execute daily manufacturing steps, operate process equipment, and ensure cGMP compliance in our Drug Product facility. This role focuses on upstream/downstream operations, in-process sampling (pH, osmolarity), documentation of batch records, and maintaining an audit-ready, cleanroom environment.

Shift: Mon–Thu 6 am–4 pm with occasional Friday and after-hours support; base pay range $31.25–$40.87 per hour, with