QC Scientist – Compendial & Analytical Quality

Lonza Biologics, Inc.; Bend (OR); On-site; Confidential; Full time

Benefits offered by this job

Day-One Insurance: Life, disability, &

401k Match: 100% up to 6%

Lonza bonus program

Job summary

Lonza Biologics, Inc. in Bend, OR seeks a QC Scientist – Compendial & Analytical Quality to review and update internal documentation based on compendial changes and ensure QC compliance with pharmacopeial monographs. The role coordinates all testing activities with external contract laboratories to ensure outsourced data meets Lonza standards.

The position is site-based, enabling close collaboration and precise execution to ensure medicines meet highest quality and safety standards.

Qualifications

• Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific field.
• 3 to 5 years of hands-on experience in a regulated (cGMP/GLP) pharmaceutical or biopharmaceutical quality control laboratory.
• Deep knowledge of global pharmacopeias (USP, EP, JP, BP) for raw materials and finished products, including verification and execution of monographs.
• Experience coordinating testing with external contract laboratories, shipping samples, and reviewing external data.
• Proficiency in analytical methods such as HPLC, GC, UV-Vis, FTIR, titration; strong technical writing for SOPs and data integrity.

Responsibilities

• Data & Report Authorization: Evaluate and authorize analytical raw data, lab notebooks, and reports to ensure data integrity and compliance.
• Compendial Monitoring: Monitor and implement compendial updates to align with regulatory standards.
• Document Lifecycle Management: Oversee end-to-end lifecycle of controlled documents, records, and material specs.
• Technical Authoring & Review: Author, review, and approve SOPs, analytical methods, and validation protocols.
• Investigations & Root Cause Analysis: Lead and support laboratory investigations and root cause analyses.
• External Testing Oversight: Manage end-to-end external testing, liaising with CROs on timelines and method feasibility.
• Procurement Coordination: Coordinate procurement, including POs for external testing services and lab consumables.

Skills

GxP knowledge

Regulated lab

Documentation

Analytical methods

Data integrity

Education

Bachelor's degree in Chemistry/Biology/Biochemistry

Tools

HPLC

GC

UV-Vis

FTIR

Titration

Job description

QC Scientist – Compendial & Analytical Quality

Bend, OR

The actual location of this job is in Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families, if needed.

Lonza is looking for a QC Scientist – Compendial & Analytical Quality to join our Quality team in beautiful Bend, Oregon. This role will be responsible for reviewing and updating internal documentation based on compendial changes and ensuring QC is in compliance with official pharmacopeial monographs. Additionally, this role will be responsible for coordinating all testing activities performed at external contract laboratories and ensuring that all outsourced analytical data meets strict regulatory standards and Lonza quality requirements.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• Work in a safe, high-quality cGMP laboratory that values your personal growth and new ideas.

• Day-One Insurance: Life, disability, and comprehensive health, dental, and vision insurance options.

• 401k Match: 100% match up to 6% of your salary, plus an extra automatic company contribution.

• Lonza bonus program: Performance-linked variable pay plan that rewards yearly company and individual success

What you will do:

• Data & Report Authorization: Evaluate and authorize analytical raw data, laboratory notebooks, and comprehensive test reports to ensure data integrity and compliance.

• Compendial Monitoring: Monitor and implement compendial updates to maintain strict alignment with evolving regulatory standards and pharmacopeial requirements.

• Document Lifecycle Management: Oversee the end-to-end lifecycle of controlled documents, records, and material specifications.

• Technical Authoring & Review: Author, review, and approve Standard Operating Procedures (SOPs), analytical methods, and validation protocols.

• Investigations & Root Cause Analysis: Lead and support formal laboratory investigations, deviations, and comprehensive root cause analyses.

• External Testing Oversight: Manage the end-to-end process for external laboratory testing, serving as primary liaison for CRO project timelines and method feasibility.

• Procurement Coordination: Coordinate procurement operations, including purchase orders for external testing services and essential laboratory consumables.

What we are looking for:

• Bachelor's degree in Chemistry, Biology, Biochemistry, or a related scientific field.

• 3 to 5 years of hands-on specific experience working in a regulated (cGMP/GLP) pharmaceutical or biopharmaceutical quality control laboratory.

• Deep knowledge of global pharmacopeias (USP, EP, JP, BP) for raw materials and finished products, including verification and execution of monographs.

• Experience coordinating testing with external contract (CMOs/external labs), shipping samples, and reviewing external data.

• Practical skill with methods like HPLC, GC, UV-Vis, FTIR, titration, and basic wet chemistry.

• Proficient with technical writing for Standard Operating Procedures (SOPs), protocols, and data integrity requirements.

• Ownership of evaluating and updating internal document based on compendial changes.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.