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Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at www.20bloc.com. We are looking for a motivated and hands-on Quality Control (QC) Analyst to join our team.

How you will add value to 20BLOC The Quality Control (QC) Analyst supports the day-to-day operation of the QC analytical laboratory within a growing biopharmaceutical start-up. This role is primarily responsible for executing routine GMP testing on in-process and final drug substance/drug product samples, with opportunities to contribute to method development, method qualification, and stability programs. The QC Analyst also plays a key role in maintaining lab compliance by authoring and reviewing SOPs, and controlled forms. This is a full-time position on site in Thousand Oaks, CA.

Key responsibilities:

Execute routine GMP assays on raw materials, in-process, drug substance, and drug product samples to support release, in-process control, and stability testing timelines. Perform compendial and non-compendial assays including HPLC (SEC, AEX/CEX, HIC, RP, etc.), ELISA, endotoxin (LAL), pH, viscosity, osmolality, and appearance testing. Accurately record, review, and report data in compliance with cGMP and data integrity requirements.

Maintain day-to-day operation of the QC lab, including instrument calibration/maintenance coordination, reagent and standard preparation, and inventory management. Author, revise, and review SOPs, analytical test methods, and controlled forms/logbooks in compliance with cGMP and phase-appropriate quality systems. Troubleshoot and problem-solve unexpected or out-of-trend results using working knowledge of assay chemistry and instrumentation. Support stability study sample pulls, testing, and timely reporting per protocol. Contribute to method development, qualification, and validation activities as assays are brought in-house or transferred from CROs.

Education

Bachelor's degree in in a biological or life sciences field. Experience 3-5 years of hands-on experience in a GMP-regulated analytical laboratory, with direct experience running analytical assays and qualification activities. Hands-on experience with multiple protein analytical methods, both compendial and non-compendial, such as HPLC (SEC, RP, AEX/CEX, HIC, etc.), ELISA, endotoxin, pH, viscosity, and osmolality.

Demonstrated experience authoring and/or reviewing SOPs, test methods, and controlled forms in a regulated environment. Experience with LC/MS analyses, potency assays, PCR, western blot, and MS-based methods is a plus. Prior exposure to method development, method qualification/validation, or stability program support.

Working knowledge of phase-appropriate quality systems, including deviations, CAPA, change control, and electronic quality management systems. Excellent interpersonal, verbal, and written communication skills, with the ability to work cross-functionally in a fast-paced start-up environment. Strong attention to detail and excellent organizational skills. This is a full-time, on-site position located in Thousand Oaks, California, and requires working on-site Monday through Friday. All applicants must be authorized to work in the United States.

We are not sponsoring employment visas.

Compensation:

The salary range for this position is $74,000.00. to $89,00.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics. We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.