QC Senior Specialist, Quality Laboratory

Overview:

This laboratory position will be in the Quality Control Department and support activities associated with routine in-process testing, Certificate of Analysis (COA) release testing, and stability program support for biologics. Person needs to have experience performing capillary electrophoresis testing (cIEF, CE-SDS). This position will demonstrate strong technical proficiency with various analytical methods, operate as a technical leader within the QC team, supporting complex testing, driving investigation quality, and ensuring compliant execution of analytical programs.

In addition, this position will oversee laboratory investigations, identify and implement CAPAs, and manage analytical method lifecycle activities including protocol drafting and execution of method validation, verification, and transfer in accordance with regulatory expectations.

Responsibilities & Duties:

• Perform and review routine in-process, release, and stability testing for biologic drug substances and drug products while adhering to GMP/GDP requirements
• Perform capillary electrophoresis testing (cIEF, CE-SDS), preferred experience
• Execute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping)
• Perform plate-based ELISA, ligand binding assays
• Perform compendial methods relevant to large molecule therapeutics (USP/EP/JP)
• Lead laboratory investigations, including OOS, OOT, and atypical result investigations
• Conduct root cause analysis and identify, implement, and verify effectiveness of CAPAs
• Draft and oversee protocols for method validation, verification, and transfer
• Interpret results, perform statistical analyses, and prepare validation reports aligned to ICH Q2 and US FDA expectations
• Author and review SOPs, test methods, protocols, and technical reports
• Ensure all work is performed in compliance with cGMP, data integrity principles, and internal QA/QC policies
• Support regulatory inspections and audits as a subject matter expert
• Maintain departmental instruments and ensure timely execution of QC quality system records
• Mentor team members and oversee analytical workflows to meet project goals

Qualifications:

• Bachelor’s, Master’s, or Ph.D. in Biology, Chemistry, Biochemistry, or a related scientific field.
• Minimum of 10 years of direct, hands-on QC experience in a GMP Quality Control laboratory supporting biologics.
• Deep technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing.
• Strong familiarity with GxP requirements required.
• Strong background in laboratory investigations, OOS management, and CAPA implementation.
• Hands-on experience with method validation aligned to ICH Q2 and US FDA regulations.
• Excellent technical writing, documentation, and analytical troubleshooting skills.
• Ability to work independently while collaborating effectively across QC, QA, and Manufacturing.
• Experience in a commercial-stage or late-phase biologics environment is preferred.
• Familiarity with LIMS and chromatography data systems (e.g., Chromeleon) is highly desirable.
• Excellent communication, interpersonal and organizational skills are required

The Base Salary Range for this position is $115,000 to $145,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.