QUALITY CONTROL (QC) LEAD

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) Lead to join our team.

How you will add value to 20BLOC

The Quality Control (QC) Lead manages our QC group, lead the day-to-day operations of the QC lab, supervising QC specialists to conduct analytical assays, plan and forecast the company’s quality control programs and needs, manage and coordinate external CROs / outsourcing labs for assay development, qualification, transfer, and support the analytical strategy and compliance of the group.

Key responsibilities

• Coordinate with CROs and outsourcing parties for the development of analytical assays with defined protocols to measure purity, potency, and stability using equipment and instruments supporting biotherapeutics.
• Transfer developed and qualified assays from CROs and outsourcing parties to in-house lab.
• Ensure the methods meet testing requirements, the laboratory operation complies with regulatory requirements, and the lots produced are consistent, safe, and efficacious.
• Oversee the execution of analytical assays by QC specialists. Such assays include ELISA, gel electrophoresis, chromatographic-based and other assays, and qualification activities following protocols on in-process and final drug substance and drug product samples.
• Write and review SOPs, analytical protocols and written reports in compliance to cGMP as needed.
• Support the day-to-day operation of the QC lab and perform routine lab activities as needed.

Education

• Bachelor degree in analytical, biological, life sciences or related field. Master or PhD preferred.

Experience

• 5-year experience working in a laboratory with hands-on experience in analytical assays and qualification activities.
• Experience with regulatory and compliance, GMP analytical testing, quality systems, SOPs and regulatory filing documents authoring.
• 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, PCR, western blot and MS-based methods a plus.

Skills & Competencies

• Working knowledge of phase appropriate quality systems, including deviations, CAPA, change control, and document management systems.
• 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.

Please apply at jobs@20bloc.com – in subject line: QC Lead

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 $90,000.00. to $110,00.00 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.