Head of QC & Protein Analytics

20bloc Inc.; Thousand Oaks (CA); Presencial; USD 110.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Descripción de la vacante

20bloc, Inc. is seeking a Head of QC & Protein Analytics to direct the day-to-day operations of the QC and developmental analytical laboratory, while owning the analytical strategy and regulatory compliance for the group. This is a full-time, on-site role in Thousand Oaks, CA.

The position requires a Bachelor's degree and 10+ years of hands-on analytical experience, with expertise in protein analytics and regulatory standards. Competitive compensation and benefits apply.

Formación

• Bachelor's degree in biological, life sciences or related field.
• Minimum of 10 years' progressive laboratory experience with demonstrated hands-on proficiency in analytical method development, qualification, and validation.
• Experience with analytical chemistry and regulatory compliance, including authoring and executing SOPs, analytical protocols, and controlled document management in accordance with ICH guidelines.

Responsabilidades

• Lead the development and execution of analytical assays to characterize purity, potency, and stability of biotherapeutic drug products, ensuring fitness-for-purpose across all development stages.
• Oversee and execute ELISA, gel electrophoresis, chromatographic-based methods, and additional qualification activities in accordance with approved protocols on in-process and drug product samples; ensure data integrity and traceability.
• Author and maintain SOPs, analytical protocols, method validation/qualification reports, and technical summaries in full compliance with cGMP requirements; ensure documentation is audit-ready at all times.
• Manage daily QC analytical laboratory operations, including instrument maintenance schedules, reagent and consumable inventories, and routine testing activities to ensure uninterrupted laboratory function.
• Serve as a subject matter expert (SME) during internal audits and regulatory inspections; proactively identify gaps in quality systems and lead corrective actions to resolution.

Conocimientos

Analytical methods

Regulatory compliance

SOP writing

Instrument maintenance

Documentation control

Cross-functional collaboration

Educación

Bachelor's degree

Herramientas

HPLC

ELISA

SEC

AEX

RP-HPLC

SDS-PAGE

CE-SDS

LAL

LC/MS

Descripción del empleo

Who we are:

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: Head of QC & Protein Analytics

Position Overview:

20bloc is seeking an experienced and highly motivated Head of QC & Protein Analytics to direct the day-to-day operations of our QC and developmental analytical laboratory, while owning the analytical strategy and regulatory compliance for the group. This role is critical to ensuring that all analytical methods meet established testing requirements, laboratory operations adhere to applicable regulatory standards, and all manufactured lots are consistently safe and efficacious. This is a full-time, on-site position located in Thousand Oaks, CA.

Key responsibilities:

• Lead the development and execution of analytical assays to characterize purity, potency, and stability of biotherapeutic drug products, ensuring fitness-for-purpose across all development stages.
• Oversee and execute ELISA, gel electrophoresis, chromatographic-based methods, and additional qualification activities in accordance with approved protocols on in-process and drug product samples; ensure data integrity and traceability.
• Author and maintain SOPs, analytical protocols, method validation/qualification reports, and technical summaries in full compliance with cGMP requirements; ensure documentation is audit-ready at all times.
• Manage daily QC analytical laboratory operations, including instrument maintenance schedules, reagent and consumable inventories, and routine testing activities to ensure uninterrupted laboratory function.
• Serve as a subject matter expert (SME) during internal audits and regulatory inspections; proactively identify gaps in quality systems and lead corrective actions to resolution.

Requirements:

• Bachelor's degree in biological, life sciences or related field.
• Minimum of 10 years' progressive laboratory experience with demonstrated hands-on proficiency in analytical method development, qualification, and validation.
• Experience with analytical chemistry and regulatory compliance, including authoring and executing SOPs, analytical protocols, and controlled document management in accordance with ICH guidelines.
• Thorough understanding of phase-appropriate quality systems, including deviation management, CAPA initiation and closure, change control, and electronic document management systems.
• Extensive hands-on experience with protein analytical methods, both compendial and non-compendial, including HPLC techniques (SEC, AEX, RP-HPLC), ELISA, electrophoretic methods (SDS-PAGE, CE-SDS), endotoxin (LAL), osmolality, pH, and appearance testing. Experience with method transfer and co-validation activities strongly preferred.
• Experience with advanced analytical techniques including LC/MS, MS-based peptide mapping, cell-based potency assays, PCR, and western blot is highly desirable.
• 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.

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 $110,000.00. to $140,000.00 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.