Director, Biologics Process Development

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Full Time San Diego, CA, US

9 days ago Requisition

Salary Range: $ To $ Annually

Job Title: Director, Biologics Process Development

Location: San Diego or Remote U.S.

Job Type: Full-Time

Who We Are

Avenzo Therapeutics, Inc. (“
Avenzo
” or “
Company
”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer.

The Company is headquartered in San Diego, California.

Position Summary

Reporting the Senior Vice President, Chemistry Manufacturing and Controls (CMC), the Director, Biologics Process Development will provide strategic and technical leadership for outsourced biologics drug substance development and manufacturing activities across clinical and commercial stages. This role will serve as the company's upstream/downstream process development and manufacturing subject matter expert, leading external CDMO/CMO partnerships to ensure reliable clinical supply while advancing manufacturing processes toward commercial readiness.

The Director will be responsible for process development oversight, manufacturing execution, process characterization, technology transfer, process validation (PPQ), regulatory support, and lifecycle management activities required to enable successful late-stage development and commercial manufacturing. Working cross-functionally with CMC, Quality, Regulatory, Program Management, and external partners, this individual will drive technical decision-making, manage development and manufacturing risks, and ensure alignment of process development strategies with broader corporate objectives and product commercialization plans.

Essential Job Functions and 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 and subject matter expert for external CDMO partnerships, including selection, governance, performance management, and manufacturing oversight
• Oversee process characterization, technology transfer, process validation (PPQ), scale-up, and commercial readiness activities to support late-stage development and product launch
• Provide technical oversight of manufacturing operations, reviewing process performance, manufacturing readiness, deviations, investigations, change controls, and ongoing process improvements
• Lead technical troubleshooting, risk assessments, root cause investigations, and mitigation strategies to ensure reliable clinical and commercial supply
• Drive development and execution of technology transfer strategies, comparability assessments, process control strategies, and manufacturing documentation.
• Partner cross-functionally with Process Development, Analytical Development, Quality, Regulatory, Supply Chain, and Program Management to achieve CMC objectives and manufacturing milestones
• Support regulatory submissions and health authority interactions, including preparation and review of IND, IMPD, BLA, and MAA CMC content and responses.
• Ensure compliance with cGMP requirements, global regulatory expectations, and internal quality…