Michael McErlean

Staff Manufacturing Process Specialist - BioNC - Wilson, NC - J&J Innovative Medicine

Role
Staff Manufacturing Process Specialist Upstream - J & J Bionc at Johnson & Johnson Innovative Medicine
Location
Philadelphia, PA, US
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Michael McErlean

Biotech Professional | 23+ Years in Pharmaceutical Operations With over 23…

Experience

  1. Staff Manufacturing Process Specialist Upstream - J & J Bionc

    Johnson & Johnson Innovative Medicine

    Mar 2025 — Present · Wilson, NC, US

    Member of the initial Operations team for what will be J&J newest flagship facility for large scale biomanufacturing. This greenfield project is J & Js first in over 20 years; initial responsibilities will include contributing to the Detailed Design Phase of the project, supporting equipment FATs (Factory Acceptance Testing), executing Commissioning, Validation & Qualification of the facility and equipment, expanding the operations team and the equivalent of reams & reams of document generation.

Education

  • Millersville University of Pennsylvania

    BS - Marine Biology

    1991 — 1995

  • Saint Joseph's University

    Master of Science - MS

    2018 — 2020

Skills

  • Design Control
  • Lims
  • Glp
  • Lean Manufacturing
  • Quality System
  • V&V
  • Six Sigma
  • Aseptic Processing
  • Root Cause Analysis
  • Cell Culture
  • 5s
  • Technology Transfer
  • Standard Operating Procedure (Sop)
  • Lifesciences
  • Project Manager
  • 21 Cfr Part 11
  • Life Sciences
  • Validation
  • Manufacturing
  • Change Control
  • Cell
  • Pharmaceutical Industry
  • Sop
  • Aseptic Technique
  • Laboratory Information Management System (Lims)
  • Process Improvement
  • New Product Development
  • Biotechnology
  • Good Laboratory Practice (Glp)
  • Capa
  • Biopharmaceuticals
  • Fermentation
  • Clinical Trials
  • Gmp
  • Vaccines
  • Project Manager - Global Teams

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Michael McErlean — Staff Manufacturing Process Specialist Upstream - J & J Bionc at Johnson & Johnson Innovative Medicine in Philadelphia, PA, US | Unifers