EXPERIENCE
BioProcess Solutions LLC, Owner - 2009- present
Founded BioProcess Solutions in March 2009 and registered as LLC in July 2009 in San Diego, CA. In 2014, relocated to the Greater Boston Area. Providing consulting services in the areas of CMC, Process Development, Scale-up, Technology Transfer, and Project Management from preclinical through clinical manufacture (Phase I/II/III) through pre-commercialization. A broad Biologics experience basis with capabilities in protein and vaccine manufacture, phage products, sustained drug delivery, and cell-based therapies.
San Diego BioProcess Forum - 2012-2014
President and Co-founder of a local networking group in the San Diego area, providing a venue for information, learning, and networking. Quarterly meetings open to the public included technical presentations focusing on technical topics related to biopharmaceutical drug development. Meetings were made possible through various industry sponsors.
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. preparation and submission of a pre-IND package to the FDA. Active participant during pre-IND meeting with FDA. Lead efforts for Process Development project 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 Process Development associates in optimization 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)