What are the responsibilities and job description for the Quality Control Associate position at 20BLOC?
Who we are: 20bloc, Inc. (www.20bloc.com) is an early-stage biopharma company creating breakthrough protein-based drugs to save lives. We are developing a safe and effective hemoglobin-based oxygen carrier for first response, organ preservation and oxygen therapy. We value and encourage innovations through robust information exchange, hard work, and team interaction. We are collaborative, we are intellectual, we are hands-on.
Job Title: Quality Control Associate
Position Overview: We are seeking a Quality Control Associate experienced in analytical methods in the area of protein biotherapeutics to support the day-to-day operation of the QC analytical lab. This person will support the QC team to assure products meet testing requirements, and laboratory operation and systems comply with regulatory requirements. This is an exciting opportunity to join a growing, 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 with 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 science 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.
- Familiarity with accreditation and/or inspection processes is a strong plus.
- 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. Strong college experience in these areas will be considered.
- Experience with LC/MS analyses and potency assay development and execution a strong plus.
- Experience with PCR, western blot and MS-based methods a strong plus.
- Excellent interpersonal, verbal and written communication skills and the ability to work cross-functionally such as with process development, are essential in this collaborative work environment.
- Strong attention to detail and excellent organizational skills are required.
This position provides an excellent opportunity for a highly motivated, collaborative individual to apply their skills and experience in an early-stage biopharma company with room for advancement while contributing to the development of a groundbreaking therapeutic protein product.
We offer a comprehensive benefits package which includes:
- Medical, dental and vision plans
- 120 hours paid time off (PTO)
- 12 paid holidays annually
- 401(k) U.S. retirement savings plan
- Employee assistance program
20bloc is an equal opportunity employer and values diversity. We provide the same opportunities disregarding race, religion, color, national origin, gender, gender identification, sexual orientation, age, marital status, veteran status, or disability status.