Biotechnology
10 biologics process development experts
These ten professionals have led biologics process development inside biopharmaceutical companies, in upstream, downstream and broader process development roles. A reader can learn how in-house teams develop manufacturing processes for biologic drugs and transfer them into production.
Professionals to explore
01—10Ajit Smith-Iyer
LinkedInExperience: Executive Director Upstream Process Development · Sutro Biopharma, Inc.
Executive Director Upstream Process Development at Sutro Biopharma, Inc. since 2024. Other roles include Sr Director Clinical Manufacturing at Bayer (2023–2024), Group Head Process Technology and Engineering at Bayer (2012–2017) and Principal Process Engineer at Bayer (2006–2012).
Edmund Rossi
LinkedInExperience: Executive Director, Process Development · Gilead Sciences
Former Executive Director, Process Development at Gilead Sciences (2021–2024). Other roles include Vice President, Process and Manufacturing Sciences at Immunomedics (2018–2020), Vice President, Process Development and Manufacturing at Immunomedics (2018) and Associate Vice President, Process Development and Manufacturing at Immunomedics (2015–2017).
Jose Zuniga
LinkedInExperience: Associate Director Bioprocess Development · Halozyme, Inc.
Associate Director Upstream Biologics at Disc Medicine since 2026. Former Associate Director Bioprocess Development at Halozyme, Inc. (2022–2024) and Bioprocess Development Scientist II at Halozyme, Inc. (2019–2022). Other roles include Senior Manager CMC Cell Culture Manufacturing at Abcuro, Inc (2025–2026) and CMC Senior Principal Process Engineer at Immunovant (2024–2025).
Kevin Clark
LinkedInExperience: Director Cell Culture Development · Johnson & Johnson Innovative Medicine
Director Cell Culture Development at Johnson & Johnson Innovative Medicine since 2023. Other roles include Sr. Manager Upstream Process Development at Patheon (2013–2014), Sr. Manager Upstream Manufacturing & Development at Laureate Biopharmaceutical Services (2012–2013) and Manager Cell Culture Process Development at Laureate Biopharmaceutical Services (2012).
Louise Ingram
LinkedInExperience: Director, Downstream Process Development · Fresenius Kabi
Vice President, Process Development and Manufacturing Sciences at Fresenius Kabi SwissBioSim since 2025. Other roles include Senior Director, Process Development and Manufacturing Sciences at Fresenius Kabi (2020–2025), Director, Downstream Process Development at Fresenius Kabi (2018–2020) and Head of Downstream Development Biosimilars at Merck Healthcare (2016–2017).
Mahesh V. Bule
LinkedInExperience: Director, Late-Stage Process Development · AstraZeneca
Director, Late-Stage Process Development at AstraZeneca since 2026 and former Associate Director and Group Lead at Kite Pharma (2022–2026). Process Development Sr. Scientist at Amgen (2021–2022) is also listed. The profile describes designing, optimizing and scaling up cell therapy processes for the treatment of cancer, and leading projects involving upstream and downstream process development and process characterization.
Michael Murphy
LinkedInExperience: Senior Scientist - Biologics Process Development (Pilot-Scale & Tech Transfer) · Pfizer
Senior Scientist, Early Bioprocess Research at AstraZeneca since 2026. Former Senior Scientist - Biologics Process Development (Pilot-Scale & Tech Transfer) at Pfizer (2023–2025), where the profile describes leading pilot-scale biologics process development and transfer-readiness work, and Scientist - Biologics Process Development (Pilot-Scale Operations) at Seagen (2021–2023).
Mukesh Mayani, PhD, P.Eng.
LinkedInExperience: Senior Director, Purification Development - Global CMC Development · Ultragenyx
Senior Director, Purification Development - Global CMC Development at Ultragenyx since 2024, where the profile describes heading and overseeing DS and DP development teams for two BLA submissions, including authoring and reviewing BLA sections. Associate Director, Genomic Medicine CMC at Sanofi (2020–2022) is also listed.
Nicole A. Bleckwenn
LinkedInExperience: Executive Director · AstraZeneca
Executive Director at AstraZeneca, with several Executive Director rows there since 2022 and a Senior Director role at AstraZeneca (2021–2022). The profile describes the current role as Executive Director of Upstream Process Development within Biopharmaceutical Development.
Ying Yang
LinkedInExperience: Director, Head of Downstream Process Development & MFG Operations, Strategic External Development · GSK
Director, Head of Downstream Process Development & MFG Operations, Strategic External Development at GSK since 2020. Former Associate Director Of Downstream Process Development and Operations at TESARO, Inc. (2017–2020) and Sr. Development Engineer II, Purification Process Development at Shire (2013–2016).
Choose the right perspective
Match the person's focus to your gap, since upstream cell culture, downstream purification and overall process development leadership call for different depth. Also consider your program stage and whether you manufacture in-house or through partners, and pick someone whose roles centered on a similar setup.
Questions to take into the conversation
- 01What process development work should be finished before a biologic enters late-stage trials?
- 02How do you plan a technology transfer so the receiving site reproduces the process on the first runs?
- 03Which process changes after early clinical supply tend to cause the most comparability trouble?
Reaching biologics process development experts
How can I contact one of these biologics process development experts?
Pick one of the 10 people on this page and choose "Book a paid call", or describe your project to find others. You offer a fee for a 15-minute call or a written answer, Instant Expert finds the person's work email and sends the invitation, and they decide whether to accept. The list covers 9 companies, including Sutro Biopharma, Inc.; Gilead Sciences and Halozyme, Inc., based on profile data retrieved on October 4, 2026. Being listed here doesn't mean someone has agreed to take calls.
How much does it cost to reach biologics process development experts?
You choose the offer, starting at $5 per person. It includes Instant Expert's 20% fee, so an offer that pays the person $100 costs you $125. You're charged only when the person books the call or sends the answer.
What if they don't reply?
You pay nothing. Instant Expert sends follow-up reminders, and if the person hasn't booked or answered within 7 days, the request expires and any hold on your card is released. You can invite several of the 10 people on this list at once and cap your total spend, so you pay only for the ones who accept.
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot and may describe past or present roles. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.
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