QC Chemistry Associate III: Lead Release & Stability

Biogen, Inc.; Northern (KY); Hybrid; USD 69,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insur.

401(k) with company match

Tuition reimbursement up to $10,000/yr

Employee stock purchase plan

Paid vacation and holidays

Job summary

Biogen, Inc. in Research Triangle Park, NC is seeking an Associate III to support QC Chemistry within cGMP-compliant systems and collaborate across teams to meet clinical and commercial milestones.

The role emphasizes release/stability testing, data integrity, and leadership in investigations and method development, with opportunities to mentor peers and contribute to key site initiatives.

Qualifications

• Bachelor's degree or Associate's degree in biological/chemistry/life sciences.
• 2+ years of laboratory experience.
• Strong knowledge of QC Chemistry release and stability methods.
• Experience with HPLC instrumentation and method troubleshooting.
• Familiarity with FDA/EMEA regulations and GMP compliance.

Responsibilities

• Performs release and stability testing.
• Authors or reviews investigational protocols, investigational reports, change control requests, validation protocols, and validation reports.
• Supports transfer, qualification, method development, analytical improvement projects, and validation of analytical methods.
• Provides technical leadership through project management including laboratory investigations.
• Maintains laboratory systems to ensure data integrity.
• Participates in site cross-functional teams as a representative of the QC Chemistry laboratory; mentors peers.

Skills

HPLC experience

Troubleshooting skills

FDA/EMEA regulations knowledge

GMP experience

Education

Bachelor's degree or Associate's degree in biological/chemistry/life sciences

Tools

LC MS

HPLC

Dissolution

Karl Fischer

GC

Job description

Biogen, Inc. in Research Triangle Park, NC is seeking an Associate III to support QC Chemistry within cGMP-compliant systems and collaborate across teams to meet clinical and commercial milestones.

The role emphasizes release/stability testing, data integrity, and leadership in investigations and method development, with opportunities to mentor peers and contribute to key site initiatives.