Director, Biologics Process Development

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 commercializationProvide strategic and technical leadership for process development, manufacturing, and CMC execution across multiple development programsServe as the technical lead and subject matter expert for external CDMO partnerships, including selection, governance, performance management, and manufacturing oversightOversee process characterization, technology transfer, process validation (PPQ), scale-up, and commercial readiness activities to support late-stage development and product launchProvide technical oversight of manufacturing operations, reviewing process performance, manufacturing readiness, deviations, investigations, change controls, and ongoing process improvementsLead technical troubleshooting, risk assessments, root cause investigations, and mitigation strategies to ensure reliable clinical and commercial supplyDrive 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 milestonesSupport 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 standards while maintaining inspection and commercial readinessProvide clear technical recommendations, risk assessments, and strategic guidance to senior leadership to support program and portfolio decisions Preferred 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 in the life sciences industry or an equivalent combination of academic and industry experienceProven experience leading biologics process development, prefer experience in mammalian cell cultureProvide technical oversight of outsourced manufacturing through CDMO partnershipsDeep expertise in monoclonal antibodies, recombinant proteins, or other biologic modalities, with strong knowledge of upstream and downstream manufacturing processesExperience with Antibody-Drug conjugation and downstream purification is a plusDemonstrated experience with technology transfer, scale-up, process characterization, process validation (PPQ), and commercial manufacturing readinessStrong understanding of downstream purification technologies, including chromatography, filtration, viral clearance, and UF/DF operationsExperience leading manufacturing investigations, technical troubleshooting, risk assessments, change management, and continuous improvement initiatives in cGMP environmentsWorking knowledge of global regulatory requirements, including FDA, EMA, ICH, and biologics CMC development and commercialization standardsExperience supporting regulatory submissions, health authority interactions, and preparation of CMC content for INDs, BLAs, MAAs, and related filingsProven track record supporting late-stage development, successful PPQ campaigns, inspection readiness, and commercialization activitiesExperience managing manufacturing networks across multiple global CDMOs and commercial-scale manufacturing operationsFamiliarity with modern biomanufacturing technologies, including single-use systems, digital manufacturing platforms, electronic batch records, and manufacturing data analytics toolsExcellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholdersStrong analytical and problem-solving abilities, with a strategic mindsetThis position requires periodic/regular travel, including up to 15% of work time, which may include overnight travel Physical Demands and Work Environment Physical Demands Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasksConstant or frequent sitting, standing, or walkingMay lift and/or move objects of various weights Work Environment Remote: Home office; expected to travel to and work from the Company’s headquarters in San Diego from time to timeSan Diego-based: On-site requirement (Monday through Thursday)Noise level in the work environment is usually moderateFast-paced, time sensitive environment with frequently changing prioritiesHandle multiple projects simultaneously Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position. Salary Range The salary range for this position is $223,000 to $233,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications. Benefits Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company’s 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time. Other Compensation The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies. The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies. Applications for this position are anticipated to close on October 31,2026. For more information about this posting, please contact careers@avenzotx.com . Equal Employment Opportunity Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member’s status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws. Notice to Search Firms/Third Party Agencies Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place.