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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Vitale, Karen, BS
Business Name Pharma Technology Resources
Certifications
Education
  • University of California at Berkeley:  B.S. Chemical Engineering
  • Regular participant in educational forums including BABCN, BioScience Forum, Bay Bio Device Breakfast, Bay Bio Therapeutic Breakfast, Association of Women in Science, San Jose BioCenter, RAPS, BioE2E, Bio2Device, Project Managers in Pharmaceuticals
  • Member of ISPE, International Society for Pharmaceutical Engineering
  • Participant in ISPE educational programs
  • Participant in Several Supervisor and Management Development Programs
  • Course work in Expert Systems Development and Programming
Business Address 35579 Reymouth Drive
Newark, CA 94560
Contact information
Telephone:
Email address:
Website URL:
Specialties
  • Project Team Management for Drug Development, Preparation of Regulatory Filings and Production Launch
  • CMC Technical Expertise for Formulation Development, Scale-up and Validation
  • Quality Assurance Systems and SOP's

 

Experience

Experience

President & Co-Founder- Pharma Technology Resources, Newark, CA

1994 to Present

  • Provide comprehensive project management services, team leadership, and program execution for product development, regulatory and validation programs, including responsibility for personnel, budgets and schedule.  Serve as point of contact for Clients.
  • Prepare regulatory filings including IND, NDA (eCTD), BLA and ELA filings with special emphasis on CMC content.  Evaluate experiments, data, development programs and reports.  Perform gaps analysis.  Serve as primary author for CMC content.
  • Provide engineering expertise and development strategies for purification processes, analytical methods and formulations.
  • Provide engineering expertise for conceptual layout of pharmaceutical facilities.
  • Provide comprehensive project management and cGMP compliant systems for manufacture of bulk drugs.
  • Manage and coordinate activities of consultants and contract labs.
  • Develop cGMP Compliance Systems and prepare SOP’s.
  • Audit facilities and procedures for cGMP compliance.

Manager of Pharmaceutical Production - Syntex Laboratories Inc., Palo Alto, CA

1993 to 1994

  • Managed pharmaceutical Processing and Packaging for a variety of dosage forms which generated ~$400 million annual revenue.

Processing Supervisor- Syntex Laboratories Inc., Palo Alto, CA

1991 to 1993

  • Front line supervisor of the Liquid and Cream Processing Area.

Manufacutring Engineer - Syntex Laboratories Inc., Palo Alto, CA

1988 to 1991

  • Provided engineering project leadership and project team management focused in the Packaging equipment area for projects ranging up to $3.25 million.

Automation Engineer - Syntex USA, Inc., Palo Alto, CA

February 1988 to August 1988

  • Provided Automation Engineering expertise to Syntex manufacturing operations worldwide. 

Pharmaceutical Engineer III - Syntex Research, Palo Alto, CA

1982 to 1988

  •  Designed and investigated a Controlled-release drug delivery system for a peptide hormone (Nafarelin) using bioerodible polymeric microspheres. 
  • Invented and optimized micro encapsulation techniques and scaled up processes.
  • Received two Research Merit Awards for outstanding technical achievement for development and optimization of an innovative micro encapsulation technique.
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