Associate Director, QC Data and Materials Management

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

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.

Key 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

Ideal Candidate 

• 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’s 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

The anticipated salary range for candidates for this role will be $170,000-$195,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

 

 

What We Offer

• A great culture, grounded in our C.O.R.E. values