We are partnering with our client, 20bloc, Inc., to hire for a Quality Control Analyst!
About 20bloc : 20bloc, Inc. (www.20bloc.com) is an early-stage biopharma company creating breakthrough protein-based drugs. We are developing a hemoglobin-based oxygen carrier for first response, organ preservation and oxygen therapy. We value innovations through hard work and quality intellectual exchange. We are collaborative. We are intellectual. We are hands-on.
Job Title : Quality Control Analyst
Position Overview : An opportunity to support the analytical development efforts and the day-to-day operation of the QC and analytical lab. The purpose is to ensure products meet testing requirements, and laboratory operation complies with regulatory requirements. This is an exciting opportunity to join an expanding start-up in a full-time position on site in Thousand Oaks, CA.
Key responsibilities :
- Assist in developing, validating and optimizing analytical methods to ensure accurate and reliable results specific to our protein-based products.
- Conduct assays under defined protocols to measure purity, potency, and stability using equipment and instruments supporting biotherapeutics.
- Execute ELISA, gel electrophoresis and chromatographic-based assays and qualification activities following protocols on in-process and final drug substance and drug product samples.
- Write SOPs, analytical protocols and written reports in compliance to cGMP as needed.
- Support the day-to-day operation of the QC analytical lab and perform routine lab activities as needed.
Requirements :
Bachelor's degree in biological, life sciences or related field.1-3 years' experience working in a laboratory with hands-on experience in analytical method development, assays and qualification activities.Experience with Regulatory and GMP analytical chemistry.Working knowledge of and exposure to phase appropriate quality systems, including deviations, CAPA, change control, and document management systems.Hands-on experience with protein analytical methods, both compendial and non-compendial, such as HPLC (SEC, AEX / CEX, HIC, RP, etc.) and additional product-specific methods such as ELISAs, electrophoretic methods (SDS-PAGE, icIEF), endotoxin, osmolality, pH and appearance preferred.Experience with LC / MS analyses, potency assay development, PCR, western blot and MS-based methods a plus.Excellent interpersonal, verbal and written communication skills and the ability to work in a cross functional collaborative work environment.Strong attention to detail and excellent organizational skills.Relocation assistance is not offered for this position.
20bloc is an equal opportunity employer and values diversity. We offer a comprehensive benefits package which includes :
Medical, dental and vision plans120 hours paid time off (PTO)12 paid holidays annually401(k) U.S. retirement savings planEmployee assistance program