Stephen Pepper
Associate Technical Project Director-cmc @Autolus Therapeutics
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WORK HISTORY
Associate Technical Project Director-cmc @Autolus Therapeutics
London, GB
Post Approval Process -Created and led the commercial post approval process, aligning process and cost of goods improvements with post approval changes with the FDA, EMA and MHRAUS-FDA, EU-EMA & UK MHRA Filing, Approval and Commercial Readiness -Planned, led, and delivered the CMC Module 3 for the FDA BLA, MHRA MAA, and EMA MAA filings, executing a multi-year strategy that consistently met or exceeded timelines-For the FDA BLA, I coordinated the daily activities of a team of over 50 authors, SMEs, technical writers, and senior leaders, leveraging deep-dive content reviews and gap analyses to ensure the clarity and completeness of each section-Lead the FDA Information Request process, leading a rapid-response team to triage and address CMC questions within tight deadlines, and provided key content for and participated in pivotal meetings with the FDA, including Late Cycle, Informal, and Type B/C interactions-For the MHRA and EMA filings, I applied lessons learned to deliver Module 3 submissions ahead of schedule, managed the D120/D180 List of Questions process for the EMA, and authored critical responses, ensuring alignment and timely delivery across regions-Supported launch readiness activities for our US launchCDMO External Manufacturing-Management of the technical relationship with our key CDMO suppliers of drug substance and critical starting materials -Participation in joint steering committees and setting long-term strategy (CoGs, Supply, Process Improvements)Process Development Leadership TeamMember of the PDLT -Participated in strategic planning for pipeline programs and leveraged the existing CMC process structure to progress the product development-Managed the CMC Advisory boards, which contributed to the overall CMC strategy-Provided overall project governance for process development projects that contributed to the Obe-Cel BLA & Pipeline projects
EDUCATION
Maynooth University
Bachelor of Science (BS), Biological and Biomedical Sciences
SKILLS
ABOUT STEPHEN PEPPER
Graduate in Biomedical Science with extensive experience in both academic and industry-based research. Experience working on R&D, GLP, and GMP projects in Europe and the US within the scope of Cell & Gene Therapies, Vector Free Delivery of Biological Molecules and API Delivery. Certifications and Training in:Executive Management • mini-MBA Project and Process Management• Agile Project Management (including SCRUM methodology)• Lean Six Sigma Green BeltQuality and EHS • Safety Management-QQI Level 6• Quality Management and Compliance in the Pharmaceutical and Related Industries• GMP Auditing • Effective Documentation Practices for GXP ComplianceCMC/Regulatory• CMC Regulatory Compliance Strategy for Cell and Gene Therapies
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