Michele Levenson
Program & Portfolio Management | Strategic Account Management | Lean Six Sigma | Operational Readiness | Commissioning & Validation | Quality & Compliance | Tech Transfer | Change Management | Life Sciences & Biopharma
- Role
- Associate Director, Senior Program Manager at Lonza
- Location
- Napa, CA, US
- LinkedIn followers
- 500 followers
About Michele Levenson
As a senior program leader with over 20 years of experience in the biopharmaceutical, pharmaceutical, and medical device sectors, I specialize in delivering complex, cross-functional initiatives that drive operational excellence, compliance, and business transformation. My background spans end-to-end project delivery, including strategic planning, process and technology transfers, facility commissioning, and large-scale validation across process, equipment, computerized systems, automation, and shipping.I’ve led global programs and multidisciplinary teams through critical phases of growth—from new facility readiness and system integrations to Lean-driven process redesign and remediation. With a strong foundation in both technical operations and stakeholder engagement, I build trusted partnerships with clients and internal teams alike, ensuring alignment with business objectives and regulatory standards.I am a certified Project Management Professional (PMP) and hold a Lean Six Sigma Green Belt. I earned my B.S. in Life Sciences with a Minor in Spanish from Penn State University and completed my Executive MBA at Saint Mary’s College of California.
Experience
Associate Director, Senior Program Manager
Oct 2025 — Present · Vacaville, CA, US
Education
Penn State University
Bachelor of Science, General Life Sciences
1996 — 2001
Saint Mary's College of California
Executive MBA
Skills
- Corrective and Preventive Action (Capa)
- 21 Cfr Part 11
- Pmp
- Auditing
- Pharmaceutical Industry
- Sop
- Verification and Validation (V&V)
- Solid Oral Dosage Forms
- Standard Operating Procedure (Sop)
- Process Qualification
- Validation
- Gamp
- Biopharmaceuticals
- Computer System Validation
- Capa
- Biotechnology
- Protein Purification
- U.s. Title 21 Cfr Part 11 Regulation
- Glp
- Cell Culture
- Change Control
- Gmp
- Quality System
- V&V
- Technology Transfer
- Lims
- Six Sigma
- Gxp
- Equipment Qualification
- Laboratory Information Management System (Lims)
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