Director, Biologics Process Development
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 companys 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 standards while maintaining inspection and commercial readiness
- Provide clear technical recommendations risk assessments and strategic guidance to senior leadership to support program and portfolio decisions
Preferred Qualifications
- Ph.D. or Masters 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 experience
- Proven experience leading biologics process development prefer experience in mammalian cell culture
- Provide technical oversight of outsourced manufacturing through CDMO partnerships
- Deep expertise in monoclonal antibodies recombinant proteins or other biologic modalities with strong knowledge of upstream and downstream manufacturing processes
- Experience with Antibody-Drug conjugation and downstream purification is a plus
- Demonstrated experience with technology transfer scale-up process characterization process validation (PPQ) and commercial manufacturing readiness
- Strong understanding of downstream purification technologies including chromatography filtration viral clearance and UF/DF operations
- Experience leading manufacturing investigations technical troubleshooting risk assessments change management and continuous improvement initiatives in cGMP environments
- Working knowledge of global regulatory requirements including FDA EMA ICH and biologics CMC development and commercialization standards
- Experience supporting regulatory submissions health authority interactions and preparation of CMC content for INDs BLAs MAAs and related filings
- Proven track record supporting late-stage development successful PPQ campaigns inspection readiness and commercialization activities
- Experience managing manufacturing networks across multiple global CDMOs and commercial-scale manufacturing operations
- Familiarity with modern biomanufacturing technologies including single-use systems digital manufacturing platforms electronic batch records and manufacturing data analytics tools
- Excellent communication and interpersonal skills with the ability to collaborate effectively with internal and external stakeholders
- Strong analytical and problem-solving abilities with a strategic mindset
- This 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 tasks
- Constant or frequent sitting standing or walking
- May lift and/or move objects of various weights
Work Environment:
- Remote: Home office; expected to travel to and work from the Companys headquarters in San Diego from time to time
- San Diego-based: On-site requirement (Monday through Thursday)
- Noise level in the work environment is usually moderate
- Fast-paced time sensitive environment with frequently changing priorities
- Handle 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 $223000 to $233000 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 Companys 401(k) 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 312026. For more information about this posting please contact .
Equal Employment Opportunity
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individuals 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 members 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.
Required Experience:
Director
