- Process engineer with 18 years of bio-processing experience in cGMP biopharmaceutical manufacturing facilities.
- Bio-processing experience in both process engineering and plant engineering roles.
- Successfully completed the start-up of three new GMP manufacturing facilities including technology transfer, building design, process equipment procurement, process commissioning and start up.
- Expert understanding of bio process equipment and validation concepts gained through successfully leading numerous interdisciplinary project teams.
- Engineering change control management.
- CAPA, RCA, discrepancy resolution team leader.
- Capital project management and equipment commissioning and qualification.
- Mammalian cell culture and purification experience.
- CIP and SIP cycle development.
- Manufacturing staff training.
- Validation I/OQ/PQ support.
- Clinical and commercial API manufacturing.
- Cell culture process optimization.
Independent Consultant, 2008 - Present
Cell Gnenesys, Inc., Hayward, CA, 2000 - 2008
- Led the process design and startup of a new 55,000 ft2 cell culture manufacturing plant in California.
- Produced whole cell immunotherapies in support of multiple phase 3 clinical trials.
- Transfer of a 50L mammalian cell culture process from the clinical manufacturing lab to a cGMP facility with capacity for product launch at 500L perfusion bioreactor scale.
- Provided manufacturing and validation support through CAPA and RCA team leadership.
cGMP Facility Design
- Responsible for the design and procurement of process equipment including pure water system, autoclaves, parts washers, media vessels, bioreactors, continuous centrifuge, commercial fill line and plant control system.
- Accurately estimated engineering data for new GMP manufacturing facility: Mass balances, volumetric scale up of process vessels and reactors, utility thermodynamic and utilization specifications.
- Developed the process equipment cleaning and sterilization program for the facility including COP, CIP, and SIP cycle development, SOP generation, and commissioning activities.
- Reviewed and approved the Software Design Specification (SDS) for the DeltaV control system and for all critical instruments.
Equipment Validation and Process Scale Up
- Led team of process and validation engineers in the commissioning and qualification of scale-up equipment such as pumps, valves, heat exchangers, Carr V12 continuous centrifuge and pressure vessels.
- Managed effort to add a DCS controlled sparger station and a tempered glycol control loop to support commercial production.
- Team leader to rework 500L bioreactor control system and piping layout to accommodate late changes to the process scale up project.
- Coached junior process engineers with product improvement and optimization projects; sterile filtration selection, equipment failure RCA and product leachable studies.
- Successfully managed multiple capital projects up to $1.2 million including engineered purchase items and construction projects.
- Project leader in the design of a novel controlled rate cryogenic freezer to accommodate freezing up to 60,000 glass product vials.
- Successfully led an interdisciplinary team to convert growth media storage from fixed SS tanks to disposable bags, resulting in a substantial savings of water, power and product intermediates.
Baxter Healthcare Co., Thousand Oaks, Ca. Manufacturing Associate, 1995 - 2000
- Provided manufacturing engineering support in the design and construction of our two suite Cell Culture/Purification/Recombinate manufacturing facility with primary responsibility for bioprocessing equipment design, procurement, commissioning and operation.
- Liaison between the engineering and manufacturing groups from conceptual design to FDA licensure.
- Responsible for the design, FAT, SAT, and qualification of six chromatography skids, chromatography columns and supporting buffer hold pressure vessels.
- Technical leader of the purification group on the contract manufacturing project team for Genetics Institute to produce Phase III clinical product.
- Technical supervisor for the GMP purification manufacturing department, coordinating process scheduling, maintenance, validation activities and documentation activities.
- Coordinated chromatography operations to produce conformance lots of product used in the BLA submission.
- Wrote purification systems SOP's prior to startup of operational qualification validation studies.
Amgen, Thousand Oaks, CA, Manufacturing Associate, 1990 - 1994
- Performed preventative maintenance of purification process assemblies in the Epogen manufacturing plant.
- Played key role in inspecting, repairing, documenting and replacing system parts in the purification operation.
- Proficiency in the CIP and SIP of stationary and portable buffer tanks and lines.
- Extensive experience packing, testing, and operating Amicon 40 cm, 60 cm, and 100 cm columns using gel filtration and ion exchange resins.
- Executed CIP and SIP validation studies, wrote protocols, performed studies,and created final reports to detail system performance.
- Revised and wrote Standard Operating Procedures for purification area systems.
Honors & Publications
Academic and Professional Affiliations
- ISPE member
Publications and Patents
- Devices for Introducing a gas into a liquid.
- A.A. General Liberal Arts and Sciences, Ventura College, California