LEON MICHAEL GORDON
PROJECT MANAGER
SUMMARY OF EXPERIENCE
Extensive experience in technical operations (engineering and manufacturing) within the pharmaceutical, biotech and fine chemical (bulk
and finish) industries; Expertise in scope development, procedure definition, project team building, and project management (planning and execution); Specialized technical knowledge in API manufacturing, biological processes and regulatory compliance.
SELECTED EXPERIENCE DETAIL
Director of Engineering/ Project Director
/ Project Manager/ Project Engineer/ Process Engineer
Client liaison; with project goal attainment responsibility; Project definition - process engineering, materials movement, traffic and automation concepts; Design coordination; Project and construction management; Regulatory compliance (contamination control and containment) and validation oversight.
Single use- disposable - upstream and downstream bio-bulk manufacturing systems:
Single use bioreactors, SUBs, from 0L to 2000L for Probiomed (Mexico).
SUB evaluations and testing for Finesse.
Concept development, specification, and inspection of single use systems for Rentschler (Germany).
Custom SUB for Centocor.
Conventional – stainless steel - bio-bulk manufacturing systems:
Upgrades of unit operations and systems for Probiomed (Mexico).
Specification and USA/ European sourcing of major equipment for bio-bulk production facility for Probiomed (Mexico).
Process evaluation and basic design of a chemical transformation and purification of vaccine adjuvant for GSK Bio.
Process evaluation (including bioreactor capacity expansion) for bulk therapeutic protein for Stryker Bio.
Specification, procurement, and inspection of custom bioreactor for TKT.
Technology transfer and concept for cell culture (bioreactor vs. roller bottle), clarification, purification facility with utilities for TKT.
Concept for recombinant bacterial therapeutic protein and viral vaccine pilot plants and filling facility, for The Allelix- Connaught Consortium Canada).
Monoclonal antibody, MAb, manufacturing and development support, new project execution and facilities engineering for Centocor
(USA & the Netherlands).
Concept for a tissue culture pilot plant for clinical studies of TPA analog, for Upjohn.
Vaccine manufacturing systems:
Evaluation of Hepatitis C vaccine process provided by Curcell for The Green Cross (South Korea).
Coordination of technical content, provided by Curcell and Kitasato, and engineering oversight for egg based flu vaccine production facility
for Adimmune (The Republic of China – Taiwan).
Commissioning and qualification of an egg based flu vaccine production facility for GSK Bio (Canada).
Project coordination and scheduling for an upgrade of a Meningitis vaccine purification and conjugation facility for Sanofi.
Process evaluation and launch facility concept for adenovirus based flu vaccine for GenVec.
Completion of construction, validation and startup of viral, egg based flu, vaccine facility for Chiron (Italy).
Technology transfer, conceptualization, and design of a multiproduct bacterial vaccine facility for Chiron (Italy).
Concept for a swine pseudorabies vaccine facility for Upjohn.
Parenteral sterile liquid filling, aseptic and terminally sterilized, pharmaceutical manufacturing systems:
Technologies evaluations, planning and cGMP concept development for multiproduct facility for Probiomed (Mexico).
Quality audit for contract manufacturing for Polpharma (Argentina & Poland).
Commissioning and qualification of vaccine adjuvant formulation/filling line for GSK Bio (USA & France).
Project coordination for a flu vaccine formulation and sterile filtration suite for Sanofi.
Upgrade and expand a multi-product vaccine sterile filling facility for vials and syringes, meeting FDA and European Union health
authority regulations for Chiron (Italy).
Solid oral dosage, SOD, manufacturing systems:
HVAC system commissioning and qualification for tableting contract manufacturer CMIC-VPS & Actavis.
Concept development and site evaluation for a multiproduct SOD facility for AFG Bio (Ukraine).
Very large scale (stirred tank) fermentation and downstream processing:
Bovine growth hormone, from recombinant bacteria, manufacturing facility including bulk lyophilization, for Upjohn.
Renovation of a semi-synthetic clindamycin base bulk antibiotic manufacturing facility, for Upjohn (Puerto Rico).
Alfa-Interferon, from recombinant bacteria, manufacturing facility, for Schering-Plough (USA& Ireland).
Concept for a semi-synthetic penicillin bulk antibiotic manufacturing facility, for Schering-Plough (Ireland).
Gentamicin bulk antibiotic manufacturing facility for Schering-Plough. (Puerto Rico & Brazil).
API manufacturing facilities:
Multipurpose synthetic bulk intermediate facility for steroids and psychotropic compounds, using novel totally contained self-discharging
nutche technology, for Upjohn (France).
Series of chemical synthesis pilot plan upgrades, for Upjohn.
Vent emission and liquid waste reduction from synthetic chemical pilot plants, for Schering-Plough.
Betamethasone steroid chemical synthesis plant and sterile finishing area, for Schering-Plough (Brazil).
Development laboratories:
Selected, acquired and master planned biotech campus and built antibody development laboratories, with animal colony, for Medarex.
Development laboratories and pilot plants for Alfa-Interferon for Schering-Plough.
Hygienic systems provider:
Custom stainless steel bioreactors.
Ultrapure water systems and sanitization schemes (CIP/SIP). o
The application of a packaged trickling filters for residential and light commercial sewage treatment systems.
Subject matter expert:
For hire as Leon Project Services.
In association with DME Alliance and Philipp Hess Associates (The Netherlands).
As part of SNC-Lavalin (Canada), Black & Veatch, Bufete Industrial (Mexico), and Grupo Profesional Planeacion y Proyectos (Mexico).
PROJECT MANAGER
SUMMARY OF EXPERIENCE
Extensive experience in technical operations (engineering and manufacturing) within the pharmaceutical, biotech and fine chemical (bulk
and finish) industries; Expertise in scope development, procedure definition, project team building, and project management (planning and execution); Specialized technical knowledge in API manufacturing, biological processes and regulatory compliance.
SELECTED EXPERIENCE DETAIL
Director of Engineering/ Project Director
/ Project Manager/ Project Engineer/ Process Engineer
Client liaison; with project goal attainment responsibility; Project definition - process engineering, materials movement, traffic and automation concepts; Design coordination; Project and construction management; Regulatory compliance (contamination control and containment) and validation oversight.
Single use- disposable - upstream and downstream bio-bulk manufacturing systems:
Single use bioreactors, SUBs, from 0L to 2000L for Probiomed (Mexico).
SUB evaluations and testing for Finesse.
Concept development, specification, and inspection of single use systems for Rentschler (Germany).
Custom SUB for Centocor.
Conventional – stainless steel - bio-bulk manufacturing systems:
Upgrades of unit operations and systems for Probiomed (Mexico).
Specification and USA/ European sourcing of major equipment for bio-bulk production facility for Probiomed (Mexico).
Process evaluation and basic design of a chemical transformation and purification of vaccine adjuvant for GSK Bio.
Process evaluation (including bioreactor capacity expansion) for bulk therapeutic protein for Stryker Bio.
Specification, procurement, and inspection of custom bioreactor for TKT.
Technology transfer and concept for cell culture (bioreactor vs. roller bottle), clarification, purification facility with utilities for TKT.
Concept for recombinant bacterial therapeutic protein and viral vaccine pilot plants and filling facility, for The Allelix- Connaught Consortium Canada).
Monoclonal antibody, MAb, manufacturing and development support, new project execution and facilities engineering for Centocor
(USA & the Netherlands).
Concept for a tissue culture pilot plant for clinical studies of TPA analog, for Upjohn.
Vaccine manufacturing systems:
Evaluation of Hepatitis C vaccine process provided by Curcell for The Green Cross (South Korea).
Coordination of technical content, provided by Curcell and Kitasato, and engineering oversight for egg based flu vaccine production facility
for Adimmune (The Republic of China – Taiwan).
Commissioning and qualification of an egg based flu vaccine production facility for GSK Bio (Canada).
Project coordination and scheduling for an upgrade of a Meningitis vaccine purification and conjugation facility for Sanofi.
Process evaluation and launch facility concept for adenovirus based flu vaccine for GenVec.
Completion of construction, validation and startup of viral, egg based flu, vaccine facility for Chiron (Italy).
Technology transfer, conceptualization, and design of a multiproduct bacterial vaccine facility for Chiron (Italy).
Concept for a swine pseudorabies vaccine facility for Upjohn.
Parenteral sterile liquid filling, aseptic and terminally sterilized, pharmaceutical manufacturing systems:
Technologies evaluations, planning and cGMP concept development for multiproduct facility for Probiomed (Mexico).
Quality audit for contract manufacturing for Polpharma (Argentina & Poland).
Commissioning and qualification of vaccine adjuvant formulation/filling line for GSK Bio (USA & France).
Project coordination for a flu vaccine formulation and sterile filtration suite for Sanofi.
Upgrade and expand a multi-product vaccine sterile filling facility for vials and syringes, meeting FDA and European Union health
authority regulations for Chiron (Italy).
Solid oral dosage, SOD, manufacturing systems:
HVAC system commissioning and qualification for tableting contract manufacturer CMIC-VPS & Actavis.
Concept development and site evaluation for a multiproduct SOD facility for AFG Bio (Ukraine).
Very large scale (stirred tank) fermentation and downstream processing:
Bovine growth hormone, from recombinant bacteria, manufacturing facility including bulk lyophilization, for Upjohn.
Renovation of a semi-synthetic clindamycin base bulk antibiotic manufacturing facility, for Upjohn (Puerto Rico).
Alfa-Interferon, from recombinant bacteria, manufacturing facility, for Schering-Plough (USA& Ireland).
Concept for a semi-synthetic penicillin bulk antibiotic manufacturing facility, for Schering-Plough (Ireland).
Gentamicin bulk antibiotic manufacturing facility for Schering-Plough. (Puerto Rico & Brazil).
API manufacturing facilities:
Multipurpose synthetic bulk intermediate facility for steroids and psychotropic compounds, using novel totally contained self-discharging
nutche technology, for Upjohn (France).
Series of chemical synthesis pilot plan upgrades, for Upjohn.
Vent emission and liquid waste reduction from synthetic chemical pilot plants, for Schering-Plough.
Betamethasone steroid chemical synthesis plant and sterile finishing area, for Schering-Plough (Brazil).
Development laboratories:
Selected, acquired and master planned biotech campus and built antibody development laboratories, with animal colony, for Medarex.
Development laboratories and pilot plants for Alfa-Interferon for Schering-Plough.
Hygienic systems provider:
Custom stainless steel bioreactors.
Ultrapure water systems and sanitization schemes (CIP/SIP). o
The application of a packaged trickling filters for residential and light commercial sewage treatment systems.
Subject matter expert:
For hire as Leon Project Services.
In association with DME Alliance and Philipp Hess Associates (The Netherlands).
As part of SNC-Lavalin (Canada), Black & Veatch, Bufete Industrial (Mexico), and Grupo Profesional Planeacion y Proyectos (Mexico).