Sr Associate II, Quality Control Biochemistry

Biogen•Research Triangle Park, NC

1d•$93,000 - $121,000•Onsite

About The Position

This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You’ll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project team, supporting both routine and non‑routine activities (including regulatory intelligence assessments) Analyze complex data sets, prepare comprehensive technical summaries, and communicate results effectively to cross-functional partners Provide informal guidance and mentorship to new or less experienced colleagues Uphold high standards of data integrity, precise documentation, and strict adherence to cGMP/cGDP or other relevant regulatory requirements Lead continuous improvement initiatives aimed at optimizing laboratory practices, operational efficiency, and scientific rigor Support laboratory readiness by overseeing equipment qualification, calibration, and resolution of technical deviations Function as the Subject Matter Expert (SME) for Biochemistry during regulatory inspections and audits Perform biochemical assays and analytical methods with demonstrated expertise in one or more specialized areas, such as chromatography, electrophoresis, enzymatic assays, structural characterization, or protein purity/identity techniques Perform technical training Other duties as assigned Who You Are Strategic thinker skilled in analytical methods such as physical characterization, functionality assays, electrophoresis, protein characterization, and chromatography Effective project manager with decisive leadership, thriving in fast-paced settings Committed to continuous improvement, innovation, and proactive problem-solving Actively contributes to technical discussions, communicates complex information clearly across teams, and supports new team members with guidance

Requirements

Bachelor’s in Biochemistry, Chemistry, or related field (Master’s preferred)
Minimum 5+ years of QC Biochemistry experience in GMP biologics/pharma manufacturing
Deep knowledge of biochemistry or expertise in analytical disciplines, including chromatography, electrophoresis, enzymatic assays, structural characterization, or protein purity/identity techniques
Experience with complex OOS investigations and data interpretation (trends, anomalies, root causes)
Familiarity with regulatory inspections and audits
Working knowledge of regulatory requirements related to lab operations and method qualification/design (i.e. CFR, ICH, USP, etc)
Skilled with business technology tools and data systems (e.g., LIMS, Smart QC, Empower, Excel, PowerPoint)
Can explain complex issues simply and contribute to small cross-functional teams
Adapts effectively to ambiguity, developing solutions without established procedures
Strong written and verbal communication skills, along with proficiency in Microsoft Word and Excel.
Excellent organizational skills with the ability to prioritize, follow through on tasks, and meet deadlines.

Nice To Haves

Project management experience
Leadership or supervisory experience
AI tool proficiency
Experience in method and instrument qualification
Knowledge of DI regulations
LEAN lab and Six Sigma training and/or certification

Responsibilities

Act as the primary team lead and represent the team in absence of Manager
Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations
Reviews tests, approves release data, and issues certificates
Authors and review protocols, change control requests, and SOPs
Serve as a technical resource for the workgroup or project team, supporting both routine and non‑routine activities (including regulatory intelligence assessments)
Analyze complex data sets, prepare comprehensive technical summaries, and communicate results effectively to cross-functional partners
Provide informal guidance and mentorship to new or less experienced colleagues
Uphold high standards of data integrity, precise documentation, and strict adherence to cGMP/cGDP or other relevant regulatory requirements
Lead continuous improvement initiatives aimed at optimizing laboratory practices, operational efficiency, and scientific rigor
Support laboratory readiness by overseeing equipment qualification, calibration, and resolution of technical deviations
Function as the Subject Matter Expert (SME) for Biochemistry during regulatory inspections and audits
Perform biochemical assays and analytical methods with demonstrated expertise in one or more specialized areas, such as chromatography, electrophoresis, enzymatic assays, structural characterization, or protein purity/identity techniques
Perform technical training
Other duties as assigned

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