Overview In this role you will ensure analytical data integrity and compliance with pharmacopeial monographs while coordinating external testing. You will update compendial processes and manage controlled documents to support cGMP quality in Bend. You'll work closely with cross-functional teams to align laboratory activities with Lonza's quality standards. This is a hands-on, site-based position offering growth opportunities and a clear impact on medicine quality and safety. You will join a collaborative, quality-driven environment focused on enabling safe therapies at scale.
Compensation / Benefits- Day-One Insurance: life, disability, health, dental, vision
- 401k Match: 100% up to 6% plus automatic company contribution
- Lonza bonus program: performance-linked pay
- On-site, fully site-based role
- Career growth and personal development opportunities
- Competitive compensation package
Responsibilities- Evaluate and authorize analytical raw data, notebooks, and test reports to ensure data integrity and regulatory compliance
- Monitor and implement compendial updates to stay aligned with regulatory standards
- Oversee end-to-end document lifecycle, records, and material specifications
- Author, review, and approve SOPs, analytical methods, and validation protocols
- Lead and support laboratory investigations and root cause analyses
- Manage external laboratory testing processes and act as primary liaison for CRO timelines and method feasibility
- Coordinate procurement for external testing services and essential lab consumables
Key requirements- 3 to 5 years of hands-on experience in a regulated (cGMP/GLP) pharmaceutical or biopharmaceutical QC lab
- Deep knowledge of USP, EP, JP, BP for raw materials and finished products
- Experience coordinating testing with external contract labs and reviewing external data
- Practical skills in HPLC, GC, UV-Vis, FTIR, titration, and basic wet chemistry
- Proficiency in technical writing for SOPs, protocols, and data integrity requirements
- Ownership of evaluating and updating internal documents based on compendial changes
- attention to detail
- strong written and verbal communication
- cross-functional collaboration
- HPLC
- GC
- UV-Vis
