Coherus Oncology · 5 hours ago
Scientist, Quality Laboratory
Camarillo, CA
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $145K/yr
10+ years expCoherus Biosciences is a company focused on biologics, and they are seeking a Scientist in the Quality Laboratory. This role involves supporting routine in-process testing, overseeing laboratory investigations, and ensuring compliance with regulatory expectations in a Quality Control Department.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Perform and review routine in-process, release, and stability testing for biologic drug substances and drug products
Execute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping)
Perform capillary electrophoresis testing (cIEF, CE-SDS)
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
Qualification
Required
Bachelor's, Master's, or Ph.D. in Biology, Chemistry, Biochemistry, or a related scientific field
Minimum of 10 years of direct, hands-on experience in a GMP Quality Control laboratory supporting biologics
Deep technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing
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
Strong familiarity with GxP
Excellent communication, interpersonal and organizational skills are required
Preferred
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
Company
Coherus Oncology
Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI, and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers.
201-500 employees
H1B Sponsorship
Coherus Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (6)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.27BKey Investors
Pharmakon AdvisorsNorthern Star PartnersShanghai Junshi Biosciences
2023-05-15Post Ipo Equity· $50M
2022-01-07Post Ipo Debt· $100M
2022-01-01Post Ipo Debt· $400M
Leadership Team
Dennis Lanfear
Founder, President, and Chief Executive Officer
Richard Hameister
Chief Technical Officer
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase