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De‑Risking Commercial

Biologics in a Volatile Market:

Aligning Capacity, Compliance, and

Continuity at 1,000–2,000L Scale

Presenter:

05-26-2026-Bora-ATE-HS-Cropped
Mike Alston Jr.
Executive Director of Operations,
Bora Biologics  
 
Mike Alston Jr. serves as executive director of operations at Bora Biologics, where he leads cGMP commercial and CDMO operations across both microbial and mammalian manufacturing platforms in San Diego. He oversees manufacturing, MSAT, facilities, project engineering, environmental health & safety, and supply chain, driving operational excellence in support of clinical and commercial biologics programs.

Mike brings more than 15 years of experience in regulated manufacturing environments, with a strong track record of scaling operations, leading capital expansion, and strengthening organizational performance. Prior to joining Bora Biologics, he served as vice president of operations at Avid Bioservices, where he led GMP manufacturing for clinical and commercial programs and provided corporate leadership for technical services, including facilities, engineering, EHS, and sustainability.

Earlier in his career, Mike held leadership roles at Sterogene Bioseparations, Merck, and ConAgra Brands. At Merck, he managed vaccine manufacturing operations and led regulatory and continuous improvement initiatives. Throughout his career, he has directed large capital programs, including the design, construction, and qualification of cGMP facilities and infrastructure ranging from cleanrooms and single-use bioreactors to central utility plants and analytical laboratories.

Known for integrating strategic vision with disciplined execution, Mike focuses on building resilient, inspection-ready operations that deliver reliable commercial supply. His leadership supports Bora Biologics’ continued expansion of its commercial manufacturing capabilities and commitment to operational excellence.