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Proven Track Record When It Matters Most

Amy Gamber: Founder & VP Consulting

Amy Gamber: Founder & VP Consulting

Amy Gamber: Founder & VP Consulting

Amy is a strategic biotech executive with 20+ years of hands-on CMC leadership experience, specializing in navigating the complex path from clinical to commercial for late-stage biotechnology and cell & gene therapy companies. Previous roles include VP of End-to-End Supply at Atara Biotherapeutics, with additional leadership experience at CSL Seqirus and Amgen


Over her career, Amy led crisis recoveries including manufacturing restart after two-year shutdown, and delivered measurable  results such as $2M annual cost savings through strategic process automation. She successfully salvaged tech transfer failures under compressed timelines, restored CDMO relationships, and built high performing teams with zero voluntary attrition during organizational transformation. She also served as an executive CMC sponsor for regulatory submissions, including INDs, BLA and post-marketing filings. 


Industry recognition includes Healthcare Businesswomen's Association Luminary Award (2024) and featured speaking roles at major biomanufacturing conferences.  

Ryan Flynn: Consultant

Amy Gamber: Founder & VP Consulting

Amy Gamber: Founder & VP Consulting

  

Ryan is a results-driven manufacturing leader with over a decade of experience leading GMP operations, tech transfers, and strategic partnerships across global biotech and pharmaceutical organizations. Ryan has a proven track record of identifying and resolving manufacturing emergencies, managing multimillion-dollar manufacturing partnerships, scaling clinical and commercial production, and driving cross-functional teams to execute complex, high-impact projects.


Throughout his career, Ryan has held roles of increasing leadership at Merck, Center for Breakthrough Medicines, and Atara Biotherapeutics, with experience negotiating vendor contracts, managing $25M+ annual budgets, and supporting product licensure in U.S. and international markets. Backed by advanced degrees in biochemical engineering and business, Ryan demonstrates a hands-on approach that bridges technical depth with strategic vision.

Erin Kanuha: Consultant

Amy Gamber: Founder & VP Consulting

Erin Kanuha: Consultant

  

Erin is a seasoned leader in technical operations and bioprocessing, bringing over 20 years of experience in the pharmaceutical and biotech industry. Her expertise spans process development, process optimization, technology transfer, GMP manufacturing, CDMO management, and continuous improvement. 


Throughout her career, Erin has led high-performing manufacturing teams and overseen complex, high stakes production campaigns. She has a strong track record in executing technology transfers, both domestically and internationally, across internal organizations and CDMO sites. Known for her commitment to quality and collaborative partnerships, Erin is passionate about helping organizations achieve their development and manufacturing goals to deliver life changing therapies to patients. 

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