Biologics Process Development Director – Remote/SD

Avenzo Therapeutics, Inc.; San Diego (CA); Remote; USD 223,000 - 233,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation & holidays

Disability insurance

Remote work option

Job summary

Avenzo Therapeutics, Inc. is seeking a Director, Biologics Process Development in San Diego or Remote U.S. to lead outsourced biologics drug substance development and manufacturing across clinical and commercial stages.

You will oversee upstream and downstream development, tech transfer, and PPQ activities while guiding cross-functional teams. The role requires extensive CMC experience, leadership in biologics, and strong collaboration with external partners to ensure reliable clinical supply

Qualifications

• Ph.D. or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, or a related scientific discipline with 8+ years of progressive CMC experience.

Responsibilities

• Lead upstream/downstream process development activities for biologics drug substance programs from early development through commercialization.
• Provide strategic and technical leadership for process development, manufacturing, and CMC execution across multiple development programs.
• Serve as the technical lead for external CDMO partnerships, including governance and manufacturing oversight.
• Oversee process characterization, technology transfer, process validation (PPQ), scale-up, and commercial readiness activities.
• Provide technical oversight of manufacturing operations, reviewing process performance and deviations.
• Lead technical troubleshooting, risk assessments, root cause investigations, and mitigation strategies.

Skills

Process development leadership

CMC execution leadership

Regulatory submissions support

CDMO partnerships management

Education

Ph.D. or Master’s in a chemical/biochemical discipline

Job description

Avenzo Therapeutics, Inc. is seeking a Director, Biologics Process Development in San Diego or Remote U.S. to lead outsourced biologics drug substance development and manufacturing across clinical and commercial stages.

You will oversee upstream and downstream development, tech transfer, and PPQ activities while guiding cross-functional teams. The role requires extensive CMC experience, leadership in biologics, and strong collaboration with external partners to ensure reliable clinical supply