Sr Associate II, Quality Control Biochemistry

Role Summary

Onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed. 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.

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

Qualifications

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