biochemistry and pharmaceutical quality assurance expert consultant resumes
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Resume of YRL, Ph.D. Consultant
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  • Biochemical
  • Chemicals
  • Medical
  • Molecular Biology
  • Pharmaceutical
  • Pharmaceutical Manufacturing

This expert received a Ph.D. in Physical Organic Chemistry from Northwestern University in Evanston, IL.

This expert has a B.S. (cum laude) in Chemistry from Saint Norbert College in DePere, WI.

Biochemistry and Pharmaceutical Quality Assurance Expert Consultant Resumes
 

This expert specializes in quality control, pharmaceutical quality assurance and regulatory affairs, medical products businesses, and chemistry. Further expertise includes manufacturing and controls (CMC) section of drug master files, DMFs, analytical methods and process plans.

This associate also specializes in form FDA 483 and warning letter responses, corrective and preventive action plans, training, and general cGMP. Furthermore this expert has experience in general validation, and Test Method Validation, negotiations with regulatory agencies, and customers. Other experience includes distributors and internal group, data analysis including specification development and rationalization, and trend analysis.

Additional specialties include expiration and retest date justification, test method characterization and validation, site qualification processes, and stem cell and pancreatic islets processing. This expert also specializes in IVD Product Design  validation documentation,Test Method Validation document evaluation, data traceability audits, manufacturing process validation master plans, and New Product Development.

This associate has demonstrated specific expertise relative to planned discontinuance of out-dated products, NDA pre-approval inspections, corrective actions, and responses and reinspection. This expert is also highly skilled with chemical manufacturing processes, good manufacturing practice (cGMP), total quality management and ISO 9001 registration processes, in vitro diagnostic reagent and instrument design control and quality control.

Consultant, Kevin Kennedy Associates Inc.

Providing biochemistry related consulting, pharmaceutical quality assurance consulting, validation studies consulting, regulatory and GMP compliance consulting, Forensic Engineering  and related expertise to a wide variety of clients.

 

Quality Assurance (QA) Director and Consultant

Allergy IVD Systems, ISO 9001 Management Representative

 

Director, Quality Assurance , Bachem California, Torrance, CA

Peptide API Manufacturer, Primary FDA Contact

 

Director, Quality Assurance & Regulatory Affairs, Peninsula Laboratories, Belmont, CA

Peptide API Manufacturer, Biologics Responsible Head

 

Director, Quality Assurance , Ciba Corning/Biotrack, Mountain View, CA

Blood Coagulation IVD Systems, Primary FDA Contact; TQM & ISO 9001

 

Director, Quality Assurance , Porton Diagnostics, Westlake Village, CA

Blood Potassium IVD System, Primary FDA Contact; Wrote 510(k)

 

Director, Quality Assurance , Baxter/Dade Division, Miami, FL

Manager, Quality Assurance , Miles/Ames Division, South Bend & Elkhart, IN

IVD Reagents & Analytical Methods Development

 

Manager, Quality Radioimmunoassay Business, Du Pont/New England Nuclear, North Billerica, MA

Manager, Analytical Laboratory Services Contract Testing Lab, Northview Laboratories, Northbrook, IL

Primary FDA & Customer Contact

Negotiated manufacturing documentation in CMC section of three INDs, including site qualification processes, to assure consistency of stem cell, and pancreatic islets processing in two multi-center (3 to 10), Phase 3, NIH-sponsored clinical trials.

Upgrading Quality System of European subsidiary of US IVD company.

Led team that wrote major section of IVD Product Design Validation document

Evaluated over 200 Test Method Validation documents

Trained over 300 people in Test Method Validation

Advised materials control team on quality and regulatory compliance

Wrote CMC sections for 4 INDs.

Conducted numerous audits of API manufacturers, testing labs and suppliers.

Conducted numerous data traceability audits for finished drug stability studies.

Coordinated interactions of NDA team with API manufacturer

Wrote API manufacturing process validation master plans

Wrote manufacturing process validation protocols and final reports

Active member of 9 Project Teams, leading 3 of them, ranging from New Product Development to planned discontinuance of out-dated products.

Led an Active Pharmaceutical Ingredient manufacturer through its first NDA Pre-Approval Inspection (PAI) and subsequent corrective actions, responses and reinspection to gain FDA District approval recommendation for two NDAs.

Organized and documented the validation of API peptide chemical manufacturing processes. Reduced quality control turnaround time 40% by streamlining specifications and product disposition process.

Managed departments of 2 to 110 employees, the latter with a $7 million (1989) budget.

Designed quality and regulatory systems complying with current Good Manufacturing Practice (cGMP) regulations for two companies.

Kept an $8 million/year product on the market by negotiating with an FDA investigator and a distributor's QA and RA staffs during a recall and inspection. Received only one Observation on the FDA 483 after a 7-day inspection.

Wrote a successful pre-market notification, 510(k), for an in vitro diagnostic device.

Promoted the four-fold growth of a product line by: Anticipating and filling need for superior professional leadership in Quality Control. Balancing manufacturing efficiency and customer needs in negotiating a process to set expiration dates for reagents. Evaluating quality control and assurance personnel, facility, equipment and documentation requirements for expansion operations in Puerto Rico plant.

Initiated Total Quality Management and ISO 9001 Registration processes.

Wrote IVD Stability Study guidelines as member of Health Industry Manufacturer’s Association (HIMA) taskforce.

Led a team developing software control and validation requirements

GMP Compliance, including the Quality System Regulation for In Vitro Diagnostics and the Guidelines for Active Pharmaceutical Ingredients, Training, Auditing, Document Control, Biologics Responsible Head

In Vitro Diagnostic Reagent and Instrument Design Control and Quality Control

ISO 9001 Management Representative and Total Quality Management Implementer

Regulatory Submissions, Customer and Regulatory Communications.

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