Ani Michael Raj
Raleigh – Durham,NC
Summary
External Manufacturing and CMC leader with experience supporting antibody-drug conjugate (ADC) and other complex fermentation development programs through clinical manufacturing readiness. Proven track record managing global CDMO networks, coordinating complex manufacturing activities across drug substance, payload, conjugation, and drug product partners, and aligning cross-functional teams across Technical Operations, Quality, Regulatory, and Supply Chain. Experienced in building manufacturing strategies, governance structures, and risk mitigation frameworks that enable phase-appropriate CMC execution for complex biologics and small molecule programs.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Associate Director | Supply Chain
Sutro BioPharma
06.2024 - Current
- External Manufacturing Leadership and Execution
- Provide strategic leadership for external manufacturing and CMC execution for antibody-drug conjugate (ADC) programs, spanning late-stage clinical development and commercial readiness.
- Own CDMO strategy, governance, and performance management across global partners supporting ADC drug substance, payload, conjugation, and drug product activities.
- Lead negotiation and execution of MSAs, MTAs, and SOWs supporting late-phase ADC manufacturing, partnering closely with Legal, Finance, and Business Development.
- Serve as escalation point for late-phase CMC, quality, and supply risks, ensuring continuity of ADC clinical supply.
- Consolidate cross-vendor ADC DS, payload, conjugation, and DP timelines to enable portfolio-level visibility and proactive risk mitigation.
- Partner with Process Development, Analytical, QA, Regulatory, and Clinical Operations teams to maintain phase-appropriate CMC readiness.
- Clinical Supply Strategy
- Provide oversight for global clinical supply planning for late-stage ADC programs, including manufacturing, labeling, packaging, and distribution.
- Lead business continuity and risk mitigation planning to protect late-phase ADC supply and support transition toward commercial manufacturing.
- Oversee purchase order strategy, accrual forecasting, and vendor invoice governance in partnership with Finance.
- Led cross-functional teams to develop and implement strategic initiatives enhancing operational efficiency.
- Oversaw project management processes, ensuring alignment with organizational goals and regulatory compliance.
- Directed resource allocation strategies to optimize productivity across multiple departments and projects.
- Mentored junior staff, fostering professional development and enhancing team performance through structured training programs.
- Collaborated with leadership to establish long-term strategic plans, driving innovation in product development initiatives.
- Implemented process improvements that streamlined operations, reduced costs, and enhanced overall service delivery.
- Facilitated stakeholder engagement sessions to gather insights, aligning project objectives with customer needs and expectations.
- Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Assisted senior leadership in managing all aspects of operations.
Program Manager
FujiFilm Diosynth Biotechnologies
Morrisville, NC
04.2022 - 05.2024
- Led complex, late-stage biologics manufacturing programs from tech transfer through GMP execution for global biotech clients.
- Served as primary client interface for program execution, governance, and issue resolution across cross-functional technical teams.
- Managed schedule, scope, and financial execution for multi-site programs aligned to client clinical and regulatory milestones.
- Implemented operational improvements that increased efficiency, reduced turnaround times, and improved delivery performance.
- Supported complex modalities, including ADC-adjacent processes, within late-stage manufacturing environments.
Scientist I
FujiFilm Diosynth Biotechnologies
Morrisville, NC
06.2018 - 09.2022
- Spearheaded the development and standardization of complicated biotechnological cell based and Biacore assays, significantly boosting the lab’s capabilities and throughput.
- Led key process improvement initiatives that refined testing methodologies and streamlined bioassay processes, markedly increasing efficiency and reducing turnaround times.
Medical Scientist
NC Department of Health and Human Services
Morrisville, NC
04.2017 - 06.2018
- Conducted high-complexity laboratory tests crucial for the detection of infectious diseases, enhancing public health response capabilities.
- Maintained rigorous quality control and compliance standards, ensuring the accuracy and reliability of test results.
Biological Science Laboratory Scientist and Lab Safety Officer
USDA APHIS VS
Frankfort, KY
08.2016 - 04.2017
- Managed critical data and compliance requirements for animal disease traceability, supporting national health and safety standards.
- Coordinated safety training and emergency preparedness, improving laboratory safety and operational readiness.
Education
Bachelor of Technology - Biotechnology
Sathyabama University
Chennai, IndiaSkills
- Leadership & Strategy
- External Manufacturing & CDMO Governance
- Antibody-Drug Conjugates (ADC)
- Stage appropriate CMC Readiness
- Executive Stakeholder & Portfolio Management
- Execution & Risk
- Phase I,and BLA Execution
- Contract Negotiation & Budget Oversight
- Risk Mitigation & Business Continuity Planning
- Operations & Systems
- Global Supply Chain Strategy
- SAP, LIMS, Microsoft Project, Power BI
- Executive Dashboards & Program Reporting
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Relationship building
- Decision-making
- Team collaboration and leadership
- Key relationship management
- Operations management
- Technical implementation
- Proposal writing
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Resolved product issue through consumer testing.
Certification
Project Management Professional (PMP) — Certified by the Project Management Institute (PMI), 2025
Languages
Hindi
Professional Working
English
Native or Bilingual
Tamil
Native or Bilingual
Interests
- Exploring famous landmarks, historical sites, and cultural attractions in a new destination
- Supporting STEM education initiatives and mentorship programs
- DIY and Home Improvement
Timeline
Associate Director | Supply Chain
Sutro BioPharma
06.2024 - Current
Program Manager
FujiFilm Diosynth Biotechnologies
04.2022 - 05.2024
Scientist I
FujiFilm Diosynth Biotechnologies
06.2018 - 09.2022
Medical Scientist
NC Department of Health and Human Services
04.2017 - 06.2018
Biological Science Laboratory Scientist and Lab Safety Officer
USDA APHIS VS
08.2016 - 04.2017
Bachelor of Technology - Biotechnology
Sathyabama University