Biopharma Data Reviewer & Assay Method QC Analyst

KBI Biopharma; Boulder (CO); On-site; USD 74,000 - 102,300; Full time

Benefits offered by this job

Annual bonus

Medical/dental/vision insurance

Paid PTO & holidays

401K matching

Job summary

KBI Biopharma, a global leader in biopharmaceutical development and manufacturing, seeks a data-focused professional to review analytical method development and testing data for in-process and drug substance samples. You will ensure accuracy, traceability, and regulatory compliance in every report.

Required are a B.S. with 5–7 years’ experience or an M.S. with 4–5 years, plus strong knowledge of cGMP. This role emphasizes data integrity, method understanding, and collaborative problem solving.

Qualifications

• B.S. degree with 5–7 years of related experience, or M.S. with 4–5 years.
• Ability to react to change productively and handle other essential tasks as assigned.
• Experience with biopharmaceutical assays and analytical method development.

Responsibilities

• Reviews data and reports associated with development and qualification of analytical methods and testing of in-process and drug substance/drug product samples.
• Verifies that calculations and documented information are present, complete, and accurate.
• Verifies that all analyses are performed per applicable standard operating procedures and test methods, and are in compliance with GMP requirements.
• Understands experiments and biopharmaceutical assays used to develop methods and/or test samples. Maintains and updates knowledge of instrumentation.
• Responsible for developing a current understanding of cGMP and other regulatory requirements.
• Reacts to change productively and handle other essential tasks as assigned.

Skills

Data analysis

Analytical method development

GMP/compliance

Documentation accuracy

Instrument knowledge

cGMP knowledge

Education

Bachelor's degree

Master's degree

Job description

KBI Biopharma, a global leader in biopharmaceutical development and manufacturing, seeks a data-focused professional to review analytical method development and testing data for in-process and drug substance samples. You will ensure accuracy, traceability, and regulatory compliance in every report.

Required are a B.S. with 5–7 years’ experience or an M.S. with 4–5 years, plus strong knowledge of cGMP. This role emphasizes data integrity, method understanding, and collaborative problem solving.