Head of QC & Protein Analytics — On‑Site, Thousand Oaks

20bloc Inc.; Thousand Oaks (CA); Vor Ort; USD 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Analytical methods

Regulatory compliance

SOP writing

Instrument maintenance

Documentation control

Cross-functional collaboration

Ausbildung

Bachelor's degree

Tools

HPLC

ELISA

SEC

AEX

RP-HPLC

SDS-PAGE

CE-SDS

LAL

LC/MS

Jobbeschreibung

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.