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

Consultant #1610

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

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.

Academic and Professional Affiliations

Publications and Patents