industrial microbiology and biochemistry expert consultant
{/sliders}
Resume of NXL Consultant
{/sliders}

  • Strategic Planning
  • Operations Management
  • Scale-Up
  • cGMP Manufacturing
  • Facilities Development

This expert obtained a Ph.D. in Industrial Microbiology / Biochemistry at the University of Oklahoma, Norman, OK.

This expert has a Master of Science degree in Industrial Microbiology / Biochemistry from University of Arkansas in Little Rock, AR .

This expert has a Bachelor of Science in Biological Science.

industrial microbiology and biochemistry expert consultant
 

This expert has carried out responsibilities as head of operations for manufacturing of human recombinant proteins produced in transgenic plants or bacterial fermentation. Business concept based on strategic manufacturing partnership with client partners.

Key Accomplishments:

Managed cGMP clinical production activities for joint IPT/NeoRX/J&J monoclonal antibody project, including extraction, purification, and filling/packaging

Supervised process development (upstream/downstream) and commercially viable production processes for the manufacturing of cGMP biologics, while emphasizing major manufacturing alliances with client entities

Established cGMP compliance programs for all biologics operations, and document/data control system, including CMC, IND, and BLA filings

Managed the design and construction program for a cGMP protein production facility

Generated tactical and strategic plans required to meet pre-clinical, clinical and commercial goals

Successfully developed and managed relationships with various state commerce departments and local governments regarding facilities development incentives

Effectively performed technical liaison duties between manufacturing partners, vendors, clients, and supportive institutions

Rendered internal cGMP consultation for $180 million somatotropin manufacturing facility, including filling/packaging (Augusta, GA), and construction/equipment specifications for $40 million cell culture facility (St. Louis, MO).

Consultant, Kevin Kennedy Associates Inc.

Expert consultant with over 25 years of experience in industrial microbiology and biochemistry.

 

Principal, consulting firm

Multiple project focus including CMC, facilities review, and cGMP auditing, Pre-IND CMC development, IND CMC documentation development and submission Client representation with FDA. Facilities validation. Development of business plans, budget analysis, and strategic planning for new start-ups. Review of IP portfolio and strategic business analysis. CMO and supply line development.

 

Senior Vice President of Operations, Chlorogen

Spearheaded process development, scale-up, and manufacturing operations for human recombinant proteins produced in transgenic tobacco. Business concept based on strategic manufacturing partnership with client partners. Key Accomplishments: Organized and led process development group and managed protein extraction and purification, Managed from a supervisory role all transgenic field activities and USDA interactions, Established outsourced CMO vendor relationships, Generated tactical and strategic plans required to meet pre-clinical, clinical, and commercial goals, Successfully established and maintained key relations with various state commerce departments and local governments concerning facilities development incentives, Designed and implemented cGMP compliance programs for all biologics operations, document/data control system, including CMC, IND, and NDA/BLA filings, Effectively performed technical liaison duties between manufacturing partners, vendors, clients, and supportive institutions.

 

Chief Technology Officer/Senior Vice President of Operations , CropTech Corporation

Functioned as chief technology/research officer and head of operations for manufacturing of human recombinant proteins produced in transgenic tobacco. Business concept based on strategic manufacturing partnership with client partners. Key Accomplishments: Productively headed overall R&D and processes development activities, Led design and construction program for biopharmaceutical facility capable of producing pharmaceutical grade proteins; oversaw construction of 100,000 s.f. integrated cGMP facility in Charleston, SC, Managed from a supervisory role all transgenic field activities and USDA interactions, Created tactical and strategic plans critical to achieving pre-clinical, clinical and commercial goals, Developed and maintained strategic relations with various state commerce department and local governments regarding facilities incentives, accurately positioned tactical milestones, rendered market development support including operating and capital budgets, Oversaw all early-stage outsourcing CMO vendor relationships.

 

Vice President of Operations, Integrated Protein Technologies, Monsanto/Pharmacia/Pfizer

Commercial cell culture, Manufacturing/process development, CMC development, Manufacturing Operations, cGMP audits, CMC development, Deputy Chief Investigator, Expert Investigator, Applications Consultant

 

Director of Operations, Cephalon Inc.

Directed the manufacture of yeast derived rhIGF-I and other materials used in treatment of neurodegenerative diseases of the central nervous system. Key Accomplishments: Supervised scale-up, production logistics (Pichia yeast fermentation), including outsourced formulation development and filling/packaging of rhIGF-I for all US and European ALS clinical trials, Supported cGMP production of small molecule drug Provigil (modafinil, anti-narcolepsy drug), Managed cGMP FDA inspections from an operations basis, Performed technical liaison and technology transfer duties between Cephalon and corporate partners (Chiron, Emeryville, CA; Kyowa Hakko, Japan), vendors, clients, and supportive institutions, Defined and provided project management for facilities and equipment construction/operation, operational logistics, and for technology transfer from bench R&D to manufacturing, Supported drug substance CMC section of NDA and prepared facility for pre-NDA (PAI) inspection, Chairman of NDA committee for IGF-1 (mytrophin).

 

Founding Partner and Vice President of Operations, Bioscience Contract Production Corp

Designed facility, initiated construction/fabrication, and managed all biopharmaceutical contract manufacturing, cGMP compliance and validation. Fermentation, purification, cell culture, filling/packaging operations. Key Accomplishments: Developed facility design and start-up operations, manufacturing plant and equipment specifications, general project management (corporate and client), and manufacturing logistics/operations as a CMO, Provided general supervision and specifications for construction of 40,000+ sq. ft. cGMP cell culture/fermentation pilot biologics production facility (Pre-clinical through Phase III). First dedicated designed cGMP biologics CMO in U. S., Managed process scale-up and designated process development activities for clients, Established and supervised QA, QC, Facilities and Engineering, Materials Control, Validation, and Production Departments.

 

Director of Manufacturing, North American Vaccine

Managed fermentation production and process scale-up development for cGMP manufacture of pertussis toxin vaccine and other pediatric vaccines. Key Accomplishments: Managed production of Bordetella pertussis toxin for clinical trials for use in acellular DPT vaccine (currently licensed product), Initiated start-up of new cGMP facility for commercial production of pertussis toxin, Supervised initial process development for production of H. influenza (currently licensed) and Meningicoccis sp. pediatric vaccines.

Let us quickly locate the best and most qualified expert or expertise you need.

800-700-4944

Full Name*
Please fill in the required field.

Email*
Please fill in the required field.

Phone*
Please fill in the required field.

Company
Please fill in the required field.

Client Need
Please fill in the required field.

Invalid Input

FEATURED CONSULTANT

Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.

CONSULTING OPPORTUNITIES

  • Poly(methylmethacrylate) Manufacturing Operations / Processes Consultants
  • Cell Phone Technologies Expert

RAPID RESPONSE

Our Business Model
At Kevin Kennedy Associates, we’ve revolutionized the consulting business by streamlining the way our clients interact with experts.