Rob Lynch
Director of Engineering at Kite Pharma
- Role
- Director of Engineering at Kite Pharma
- Location
- Frederick, MD, US
- LinkedIn followers
- 500 followers
About Rob Lynch
Over 20+ years of experience in the biotech industry.Management of Facility and Equipment validation of both small scale and large scale clinical/commercial manufacturing facilities.Management of corporate cleaning, analytical instrument, computerized system & shipping validation programs.Authored BLA validation sections for the submission of multiple products including BENLYSTA and Raxibacumab.Participated in numerous regulatory audits from FDA, EMA and numerous international agencies including Health Canada, Brazil (ANVISA), Taiwan, Turkey, Mexico (Cofepris) and South Korea.Specialties: Large and Small scale biotech facility startup, commissioning and validation. Expertise in Facility/Equipment, Cleaning, Analytical Instrument and Shipping validation.Proficient in technical writing, presentations, project management and audit participation.
Experience
Director of Engineering
Jun 2023 — Present · Frederick, MD, US
Responsible for Engineering, Capital Projects, Commissioning, Qualification and Validation at Kite\'s TCF05 Manufacturing Facility in Frederick, MD.
Education
Towson University
BS, Chemistry
1987 — 1993
Skills
- Project Management
- Analytical Instrument Validation
- Purification
- Technical Writing
- Technical Presentations
- 21 Cfr Part 11
- Analytical Skills
- Trackwise
- Shipping
- Cleaning Validation
- Regulatory Audits
- Cip
- U.s. Food and Drug Administration (Fda)
- Facility/Equipment Validation
- Biopharmaceuticals
- Glp
- Validation
- Gxp
- Aseptic Processing
- Cmc Development
- Gmp
- Commissioning
- Capa
- Corrective and Preventive Action (Capa)
- Biotechnology
- Fda
- Shipping Validation
- Pharmaceutical Packaging
- Change Control
- Computer System Validation
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