Florian Richter

About Florian Richter

QUALIFICATIONS• Over 18 years of industrial experience in biopharmaceuticals, External Manufacturing / CDMO relationship management, project management, CMC, drug development, and supply chain. • Extensive manufacturing and operations experience in clinical, commercial, and third party manufacturing. • Extensive experience in managing oversight, performance, and governance of third-party manufacturers from Drug Substance to Drug Product, fill-finish, packaging, warehousing, and distribution.• Deep expertise in contract negotiations, risk management frameworks, and continuous improvement methodologies. CAREER SUMMARYDirector with proven ability to lead direct reports and cross-functional teams in the execution of large, complex projects supporting corporate objectives, client requirements, CMC timelines, and budgetary commitments. Recognized for building strong cross-functional partnerships, facilitating effective project governance, and aligning stakeholders around integrated, data-driven decisions. Extensive experience in project management as well as overseeing CDMO performance and governance, including CDMO selection, contract initiation, detailed scope development, and end-to-end client-based project management. Brings deep expertise across research, development, and commercial-scale manufacturing processes, with a consistent track record of delivering results through disciplined execution and collaborative leadership.

Experience

1. Director, External Manufacturing, External Operations

   Halozyme, Inc.

   Sep 2023 — Present · San Diego, CA, US

   Acting as a Halozyme leader dedicated to full-time, on-site support at the defined drug substance site of manufacture to ensure consistency of output and delivery per established manufacturing and release plans, on time, in full and on budget.• Collaborating with QA, QC, MSAT, Manufacturing, Development, Supply Chain, Operations Strategy, Finance, and Contracts to facilitate successful execution of all functional metrics, Quality plans, manufacturing supply plans, demonstrating full financial control for the product(s) being manufactured.• Responsible for all contractual elements between Halozyme and external partners.• Leading and executing pricing negotiations and cost reduction workshops. • Responsible for implementing and streamlining governance structures for all external partners. • Supporting budget and forecast consolidation for outsourced service fees.• Leading process improvement initiatives as well as establishing supplier management processes and tools. • Creating complex project plans and site performance dashboards. • Coordinate and formally validate 3PL physical counts in partnership with Supply Chain and Finance, ensuring documentation integrity and audit readiness.• Drive initiatives to enhance inventory visibility and reporting accuracy across external partners.• Monitoring, supporting, troubleshooting, and communicating, day to day batch specific updates (including process monitoring, event triage, batch review and release prioritization), in-house and outsourced analytical testing plans and supply chain/ inventory management systems.• Responsible for Identifying areas of compliance and operational risks, develop improvements, and take action to close gaps and risks.• Supporting audits and inspections at external partner sides. • Proactively identifying risks, escalating unresolved issues, and supporting structured resolution with delivery leads.• Managing escalation paths per governance tier; ensure timely closure of open actions.

Education

• California State University, Long Beach

  NA, Biology, English

  2005 — 2006

• Carl von Ossietzky University of Oldenburg

  M.S., Biology (Genetics, Microbiology, Immunology)

  2000 — 2007

Skills

• Fermentation
• Drug Discovery
• Biotechnology
• Pharmaceutical Industry
• Glp
• Gmp
• Project Management
• Change Control
• Fermentation Process Development
• Molecular Biology
• Capa
• Drug Development
• Biopharmaceuticals
• Technology Transfer
• Biochemistry
• Cell Culture
• Fermentation Technology