Associate Director, QC Data and Materials Management

Role Summary

We are seeking an Associate Director, QC Data and Materials Management to support key QC infrastructure processes. This role has oversight of QC critical reagents and reference standard management and has primary responsibility for QC data management and administration of the QC LIMS system. The ideal candidate has a broad range of QC experience in the biologics manufacturing industry and is knowledgeable about GMP laboratory operations and systems management, including LIMS systems, stability study management, and reference standard management.

Responsibilities

• QC materials oversight, including:
  • Manage lifecycle of QC critical reagents and reference standards at all stages of product development
  • Synchronize change management of critical reagents/materials and reference standards across multiple vendor sites in alignment with program team requirements
  • Perform technical review of material qualification and re-evaluation protocols, reports, and analytical data received from vendors
  • Coordinate QC material and sample shipments to support analytical testing activities at vendor sites
  • Author controlled documents to support QC systems and infrastructure
• QC data management oversight, including:
  • Overall responsibility for LIMS system administration for QC team
  • Manage QC LIMS system changes, including updates to system master data (specifications, methods, reporting units) and workflows (automated data parsing/upload, data approval, reporting workflows)
  • Support computer system validation and change control activities for LIMS system upgrades and enhancements in partnership with QA team and SaaS provider(s)
  • Manage stability protocol configurations and updates in LIMS

Qualifications

• BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)
• 10+ years of biotech industry experience in QC operations, systems, or analytical support roles
• Understanding of analytical techniques relevant to monoclonal antibody release and stability testing
• Experience in relationship management with external analytical test sites
• Ability effectively prioritize and manage multiple projects
• Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing
• Excellent communication skills; able to collaborate effectively across multidisciplinary teams
• Successfully exhibit Apogee‚Äôs C.O.R.E. values: Caring, Original, Resilient and Egoless
• Self-direction, motivation, problem solving and decision-making abilities
• Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership
• Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations
• Collaborate with the vendor on on-going system issues, upgrades, and maintenance
• Position requires travel up to 6-8 times per year, based on business needs

Skills

• QC operations and systems
• LIMS administration
• Stability study management
• Reference standard management
• Analytical techniques for monoclonal antibody release and stability
• Vendor relationship management
• Quality systems and cGMP
• Cross-functional collaboration

Education

• BS or higher in analytical chemistry, biochemistry, or related field