Director, Biologics Process Development

Avenzo Therapeutics

. Provide strategic and technical leadership for outsourced biologics drug substance development and manufacturing across clinical and commercial stages .

Posted 9/29/2026full-timeSan Diego • California • United StatesLead💰 $223,000 - $233,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biologics drug substance development and manufacturing, with a strong focus on upstream and downstream processes, technology transfer, and regulatory compliance. Proven ability to lead cross-functional teams and manage CDMO partnerships while ensuring adherence to cGMP standards and successful regulatory submissions.

Highest-signal resume keywords

Ph.D. Or Master’s Degree In Chemical EngineeringBiologics Process Development LeadershipTechnical Oversight Of CDMO PartnershipsDownstream Purification TechnologiesRegulatory Submissions And Health Authority Interactions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process CharacterizationTechnology TransferProcess Validation (PPQ)Scale-UpMammalian Cell CultureMonoclonal AntibodiesRecombinant ProteinsAntibody-Drug ConjugationChromatographyFiltration

Soft Skills

Excellent CommunicationInterpersonal SkillsAnalytical AbilitiesProblem-SolvingStrategic Mindset

Tools & Technologies

Single-Use SystemsDigital Manufacturing PlatformsElectronic Batch RecordsManufacturing Data Analytics Tools

Industry Keywords

CGMP ComplianceGlobal Regulatory RequirementsFDAEMAICHCMC DevelopmentCommercialization StandardsInspection ReadinessLate-Stage DevelopmentChange Management

About the role

Key responsibilities & impact

Provide strategic and technical leadership for outsourced biologics drug substance development and manufacturing across clinical and commercial stages
Lead upstream and downstream process development activities from early development through commercialization
Serve as technical lead and subject matter expert for external CDMO/CMO partnerships, including selection, governance, performance management, and manufacturing oversight
Oversee process characterization, technology transfer, process validation (PPQ), scale-up, and commercial readiness activities
Provide technical oversight of manufacturing operations, including process performance, manufacturing readiness, deviations, investigations, change controls, and process improvements
Lead technical troubleshooting, risk assessments, root cause investigations, and mitigation strategies
Drive technology transfer strategies, comparability assessments, process control strategies, and manufacturing documentation
Partner with Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Program Management, and external partners
Support regulatory submissions and health authority interactions, including IND, IMPD, BLA, and MAA CMC content and responses
Ensure compliance with cGMP requirements, global regulatory expectations, and internal quality standards
Maintain inspection and commercial readiness
Provide technical recommendations, risk assessments, and strategic guidance to senior leadership
Report to the Senior Vice President, Chemistry Manufacturing and Controls (CMC)

Requirements

What you’ll need

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 experience
Proven experience leading biologics process development; mammalian cell culture experience preferred
Experience providing technical oversight of outsourced manufacturing through CDMO partnerships
Deep expertise in monoclonal antibodies, recombinant proteins, or other biologic modalities
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 single-use systems, digital manufacturing platforms, electronic batch records, and manufacturing data analytics tools
Excellent communication and interpersonal skills
Strong analytical and problem-solving abilities with a strategic mindset
Ability to travel periodically/regularly, including up to 15% of work time and possible overnight travel
For San Diego-based employees: on-site Monday through Thursday

Benefits

Comp & perks

Group healthcare plans: medical, dental, vision, and basic life and AD&D insurance
Short-term and long-term disability insurance
Flexible spending accounts
Health savings accounts
Voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
401(k) plan
10 hours of paid vacation accrued every month
1 hour of paid sick leave accrued for every 30 hours worked
17 paid holidays each calendar year, including a winter closure
Annual discretionary bonus
Equity award
Remote home office arrangement for remote employees
Company travel and work-from-headquarters opportunity/requirement as applicable