Rob Lynch

Rob Lynch Email and Phone Number

Director of Engineering at Kite Pharma @ Kite Pharma
Rob Lynch's Location
Frederick, Maryland, United States, United States
Rob Lynch's Contact Details
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.

Rob Lynch's Current Company Details
Kite Pharma

Kite Pharma

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Director of Engineering at Kite Pharma
Rob Lynch Work Experience Details
  • Kite Pharma
    Director Of Engineering
    Kite Pharma Jun 2023 - Present
    Santa Monica, California, Us
    Responsible for Engineering, Capital Projects, Commissioning, Qualification and Validation at Kite's TCF05 Manufacturing Facility in Frederick, MD.
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  • Kite Pharma
    Associate Director Of Validation At Kite Pharma
    Kite Pharma Aug 2019 - Jun 2023
    Santa Monica, California, Us
    Responsible for planning, execution and oversight of the Commissioning, Qualification and Validation (CQV) for the TCF05 Facility in Urbana, MD.
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  • Glaxosmithkline
    Validation Manager
    Glaxosmithkline Aug 1999 - Aug 2019
    Brentford, Middlesex, Gb
    Responsible for Rockville Biopharma site cleaning, analytical instrument, shipping and computerized system validation programs. Previous management experience includes facility and equipment validation of clinical, small scale and large scale manufacturing facilities, participation in multiple capital projects and project management. Participated in the inspection, approval and licensure of two biopharmaceutical drugs (BENLYSTA and Raxibacumab) by FDA as well as regulatory approvals by several foreign regulatory agencies. Human Genome Sciences, Inc. was acquired by GSK during 2012.
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  • Human Genome Sciences
    Associate Director Validation
    Human Genome Sciences Aug 1999 - Dec 2012
    Rockville, Md, Us
    Responsible for corporate cleaning, analytical instrument, shipping and computerized system validation programs. Previous management experience includes facility and equipment validation of clinical, small scale and large scale manufacturing facilities, participation in multiple capital projects and project management.
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  • Intracel Corporation
    Sr. Research Specialist/Validation Engineer
    Intracel Corporation May 1994 - Aug 1999
    Held multiple positions within Intracel (formerly PerImmune). Performed purification of apolipoproteins and other general laboratory responsibilities within a GLP lab setting. Performed qualification of laboratory equipment in GMP setting
  • Synthecell/Vega Biomolecules Corporation
    Production Chemist
    Synthecell/Vega Biomolecules Corporation Nov 1993 - Mar 1994
    Synthesis of custom peptides and purification of peptides via HPLC methods.

Rob Lynch Skills

Validation Gmp Biotechnology Biopharmaceuticals Cleaning Validation Glp Fda Change Control Purification 21 Cfr Part 11 Gxp Aseptic Processing Capa Technical Writing Computer System Validation Project Management Analytical Skills Trackwise Shipping Commissioning Cip U.s. Food And Drug Administration Good Manufacturing Practice Technical Presentations Shipping Validation Analytical Instrument Validation Facility/equipment Validation Pharmaceutical Packaging Cmc Development Regulatory Audits Corrective And Preventive Action

Rob Lynch Education Details

  • Towson University
    Towson University
    Chemistry

Frequently Asked Questions about Rob Lynch

What company does Rob Lynch work for?

Rob Lynch works for Kite Pharma

What is Rob Lynch's role at the current company?

Rob Lynch's current role is Director of Engineering at Kite Pharma.

What is Rob Lynch's email address?

Rob Lynch's email address is ro****@****gsk.com

What schools did Rob Lynch attend?

Rob Lynch attended Towson University.

What are some of Rob Lynch's interests?

Rob Lynch has interest in Golf, Sports, Electronics.

What skills is Rob Lynch known for?

Rob Lynch has skills like Validation, Gmp, Biotechnology, Biopharmaceuticals, Cleaning Validation, Glp, Fda, Change Control, Purification, 21 Cfr Part 11, Gxp, Aseptic Processing.

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