Director, Cell & Gene Lab Manufacturing Operations

Discovery Life Sciences; Alameda (CA); Sur place; USD 150 000 - 170 000; Plein temps

Avantages offerts par ce poste

Dental & vision package

Life insurance

Disability coverage

401(k) match

Generous vacation & PTO

Professional development

Employee Referral Program

Résumé du poste

Discovery Life Sciences in Alameda, CA is seeking a Director of Lab Manufacturing Operations to lead GMP cellular starting materials production across Cell & Gene Therapy sites. You will drive safe, compliant operations and develop manufacturing teams.

This hands-on, strategic role requires a strong background in cGMP, cleanroom management (ISO7/8), leukapheresis processes, and CAPA-driven quality improvement, with a focus on right-first-time execution.

Qualifications

• Bachelor's degree in Biology, Biomedical Engineering, Biological Sciences, Biotechnology, or related discipline.
• California CLS or MT-ASCP license.
• Minimum 5 years in a cGMP manufacturing environment (cell therapy, biologics, etc.).
• Minimum 3 years of leadership in manufacturing teams.
• Experience leading cleanroom operations (ISO7/ISO8).
• Direct experience with leukapheresis products and isolated cell manufacturing preferred.
• Strong knowledge of cGMP, GTP, 21 CFR Part 1271.
• GMP documentation: batch records, SOPs, deviations, CAPAs, investigations, changes.

Responsabilités

• Lead GMP manufacturing operations across Cell & Gene Therapy sites.
• Develop manufacturing managers, supervisors and technicians.
• Ensure compliance with cGMP, GTP, FDA and quality requirements.
• Oversee batch records, deviations, investigations, CAPAs, and change controls.
• Maintain environmental monitoring and trend analysis.
• Coordinate production planning to meet donor volumes and timelines.
• Support batch disposition and inspection readiness with QA/QC.
• Lead continuous improvement for efficiency and data integrity.

Connaissances

Biology degree

CLS/MT license

cGMP experience

Leadership

Cleanroom ISO7/ISO8

Leukapheresis/cell therapy

GMP documentation

Environmental monitoring

Closed-system processing

CAPAs investigations

Lean manufacturing

Formation

Bachelor's degree in Biology/Biotech

Outils

Sepax

LOVO

Cryogenic storage systems

Description du poste

Discovery Life Sciences in Alameda, CA is seeking a Director of Lab Manufacturing Operations to lead GMP cellular starting materials production across Cell & Gene Therapy sites. You will drive safe, compliant operations and develop manufacturing teams.

This hands-on, strategic role requires a strong background in cGMP, cleanroom management (ISO7/8), leukapheresis processes, and CAPA-driven quality improvement, with a focus on right-first-time execution.