Mathew Tench
15+ years Pharma Experience / Expert in Program Management / Manufacturing / Leading Teams / GMP environments / Training and Development
- Role
- Director, Project Lead Commercial Programs, Cell and Gene Therapy at Lonza
- Location
- Cleveland, OH, US
- LinkedIn followers
- 500 followers
About Mathew Tench
I am a program management and manufacturing leader in regulated environments with expertise in regenerative medicine, GMP sterile processing, training and development, continuous improvement, regulatory compliance, and laboratory operations. I believe that companies and communities succeed based on engagement and trust. When joining a team, I seek to develop a culture where positive and negative feedback are welcome and voices are heard. I have employed this approach from Rec Soccer to Sterile Manufacturing.
Experience
Director, Project Lead Commercial Programs, Cell and Gene Therapy
Aug 2022 — Present · Houston, TX, US
The Project Lead, Commercial Programs manages successful advanced development of late-stage cell and gene therapy products including transition from early phase development, technology transfer, validation (PPQ), submission and launch. This covers end to end all necessary technical, regulatory, quality, etc. aspects, which are required for a successful commercial launch of a product in collaboration with all disciplines.
Education
Ohio University
Bachelor of Science (BS), Microbiology, General
1995 — 1999
Skills
- Formulation
- Hazwoper
- Quality Auditing
- Aseptic Processing
- Recruitment/Retention
- 5s
- Uv
- Production Managment
- Lms Administration
- Quality Control
- Change Control
- Gmp
- Training & Development
- Formulation Development
- Product Development
- Employee Training
- Wet Chemistry
- Cgmp Practices
- Validation
- Project Facilitation
- Project Management
- Gas Chromatography
- Incident Command Certified
- Ir
- Instrument Validation
- Anda
- Continuous Improvement
- V&V
- Process Simulation
- Production Management
- Cleaning Validation
- Methods Development
- Glp
- Capa
- Controlled Document Systems Administration
- Sop
- Fda
- Compliance Audits
- Learning Management Systems
- Trackwise
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