EXPERIENCE
BioProcess Solutions, Owner (2009- present)
Founded BioProcess Solutions in March 2009. Providing consulting services in the areas of Process Development, Scale-up, Technology Transfer, and Project Management. Based on 15 years of experience in the Biotech field, covering a broad range of technologies, including cell based therapies, biopolymers, sustained release drug delivery, mammalian cell recovery and recombinant protein isolation from preclinical through Phase III clinical studies.
Director Preclinical Development (2006-2007)
MicroIslet, Inc., San Diego, California (part-time basis)
Coordinated preclinical and regulatory efforts for a cell based therapy for Type 1 Diabetes:
· Project management of preclinical studies in preparation for IND. Responsible for rodent and primate studies at contract facilities, including writing/reviewing protocols and procedures, scheduling, and auditing.
· Responsible for the preparation and submission of a pre-IND package to the FDA. Active participant during pre-IND meeting with FDA.
· Responsible for writing, maintaining, and reviewing company operation timelines (MS project).
· Lead efforts to evaluate alternative alginate and chelator sources for the encapsulation of porcine islets.
Director, Process R&D (2001 to 2005)
MicroIslet, Inc., San Diego, California
Responsible for the process research and development efforts to prepare MicroIslet’s encapsulation technology for IND enabling studies:
· Assembled and managed a process development team for process refinement.
· Developed and optimized the prototype encapsulation technology and demonstrated proof-of-concept in vivo. The process was based on the encapsulation of live tissue in alginate droplets using an electrostatic droplet generator. Material was prepared under aseptic conditions for implantation.
· Prepared and reviewed procedures, SOPs and batch records.
· Hired and managed scientist for analytical methods development. Assays included capsule diffusivity, capsule size, capsule strength, etc.
· Responsible for the preparation of product for safety and efficacy studies in animals.
· Co-Investigator in NIH SBIR grant.
Senior Scientist, Process R&D (1998 to 2000)
Monsanto/CP Kelco (formerly Kelco Biopolymers), San Diego, California
Management and process leader position covering a variety of products:
· Designed and optimized a manufacturing process for the isolation of active natural components from food sources for use in nutritional supplements. Scaled up process and conducted initial feasibility manufacturing runs at a contract facility.
· Project leader for novel food biopolymer products coordinating efforts across multiple disciplines. Lead process development efforts to develop a recovery process eliminating off-flavor formation for a food biopolymer product (gellan gum). Completed scale-up of this process to commercial scale. Efforts resulted in pending patent.
· Assisted in the scale-up and transfer to GMP for the production of sterile ultrapurified alginate product for pharmaceutical applications. Prepared GMP documentation for the process (SOPs and batch records).
Senior Process Engineer/Process Engineer, Process Development (1994 to 1998)
Pacira Pharmaceuticals (formerly DepoTech Corp), San Diego, California
Process optimization and scale-up for DepoFoam sustained drug delivery products. The technology is based on liposomes formed by a double emulsion process using high shear mixers followed by a purification and formulation step using microfiltration.
· Collaborated in the scale-up and optimization of the DepoCyt process (for the intrathecal treatment of lymphomatous meningitis).
· Instrumental in the design, installation, commissioning and validation of the aseptic automated process equipment for DepoCyt consisting of high shear emulsion system, tangential flow filtration, CIP/SIP, etc...
· Developed GMP SOPs and batch records, and provided training.
· Lead a team for the preparation of the first clinical batches of DepoCyt.
· Provided technical support for GMP Manufacturing.
· Designed small scale automated process equipment for Process R&D purposes.
· Investigated alternative technologies for the preparation of emulsion-based DepoFoam products. Efforts resulted in various presentations and one pending patent.
· Managed a group of interns and associates in process development studies.
Senior Process Associate/Process Associate, Process Development (1992 to 1994)
Biogen Inc., Cambridge Massachusetts
Process development for cGMP production of biologics (Beta Interferon, Hirulog, LFA3-TIP, etc.):
· Unit operations included mammalian cell culture, bacterial fermentation, clarification, protein purification
· Designed and performed laboratory and pilot scale experimentation for process development and scale-up.
· Specified, designed, and implemented clarification system for mammalian cell cultures for phase 1 clinical production.
· Assisted in the procurement, installation, and validation of process equipment for the ß-Interferon clinical production.
· Involved in technology transfer to GMP facility (documentation and validation of cell recovery processes for Phase I trials)
EDUCATION
M.S. Chemical Engineering
Thesis: “Analyze and model the secretion mechanism of glucoamylase in filamentous fungi”; Tufts University, Medford, Massachusetts, 1992
Diploma in Chemical Engineering (Equivalent to B.S.)
Thesis: “Synthesis and characterization of low extractable reverse phase materials for HPLC – Carbamate bonded diol silica.”; Fachhochschule für Technik Mannheim (PolyTechnic Institute), Germany, 1989
