Bio Process Consultant With Hands-On Experience in cGMC Biophamaceutical Manufacturing and Bio Facilities Start-up

Technical Consultant #1610


Expertise

  • 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.

Experience

Independent Consultant, 2008 - Present

Cell Gnenesys, Inc., Hayward, CA, 2000 - 2008

Process Engineer

  • 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.

Project Management

  • 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.

Education

  • A.A. General Liberal Arts and Sciences, Ventura College, California
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