Biopharma Manufacturing Consultant · ASME BPE
Alec Grusky
Biopharma manufacturing consultant · Inventor, Weld DDVS
About
Ten years in biopharma manufacturing, from the plant floor at Biogen to system turnover
at Fujifilm Biotechnology in Holly Springs. Recognized with Biogen’s CEO Award
for column packing documentation improvements and cross-shift training. Independent consultant
since 2023, founder of PharmaTech Consulting, and inventor of Weld DDVS — a patented
deterministic system for verifying weld documentation against ASME BPE rules.
Selected work
$1M / yr · 16h per batch
Identified and implemented a buffer optimization process at Biogen.
CEO Award — Top Employee, Biogen
Column packing documentation improvements and cross-shift column packing training.
System Owner — bluebird bio
Aligned and approved upstream SOPs, BPRs, and validation documents as the assigned System Owner. Set the site-standard template baseline for upstream documentation.
500 → 120 protocols
Led STW protocol template development in Kneat phase 1 → 2 at Fujifilm Holly Springs. 76% protocol reduction, faster qualification cycles.
100+ system turnovers
Direct-impact system start-up and turnover at Fujifilm Holly Springs — downstream-focused. Document top review, FATs, loop checks, engineering shakedown.
