Propulsion Engineer, Electric Drive Thermal
General Motors
Associate Director, QC Data and Materials Management
Apogee Therapeutics
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $170,000 - $195,000 per year
Job Level
Senior
About the role
- 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
- 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
- Collaborate with the vendor on on-going system issues, upgrades, and maintenance
Requirements
- 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
