Pharmaceutical Analytical R & D, (CGMP, CGLP, FDA), Quality-Compliance Expert

Expertise

Summary

Over 15 years of pharmaceutical industry acumen, new product development through life-cycle management (post-marketing support) process, with the ability to address regulatory requirements set forth by the FDA and other health authorities. Effective problem solver with the ability to apply technical expertise and solutions to diverse situations successfully.

• Analytical research and development in the pharmaceutical industry.
• Project management.
• Test method development.
• Process development.
• cGMP, cGLP, FDA, and ICH Quality and Compliance.
• Technology development and site transfers.
• Developmental stability program management and setting expiration dating.

Experience

Undisclosed Company, Principal Consultant and Founder, Present

• Identify requirements for documentation to be submitted to the Department of Health.
• Author permit applications and other scientifically technical documents for various companies.
• Prepare proposals for lab setups and analytical testing projects for various companies.
• Advisory board member for emerging companies.
• Conference presentation subject matter expert and panelist on pharmaceutical industry, (GMPs, GLPs).

Johnson & Johnson Consumer Inc., (McNeil Consumer Healthcare), 2005 - 2017

Manager, Analytical Research and Development    

• Oversaw the Analytical Support to Marketed Products group responsible for analytical method development and validation, method transfer, and qualifying marketed product release and stability testing sites.
•  Managed relationships with top-tier management services companies in the healthcare space
• Analytical project manager and sponsor on cross functional teams (product launches, manufacturing resitings, process improvements, technical transfers, and analytical method development, validation and transfers).
• Contributed as a subject matter expert for new EDC and LIMS systems for use within our labs.
• Developed relationships and worked collaboratively on cross-functional project teams which included Marketing, Medical Affairs, Regulatory Affairs, Project Management, Formulators, Operations, IT and QA/QC.
• Prepared and reviewed CMC documents for NDA and sNDA filings.
• Managed the developmental stability testing program supporting product shelf-life expiry.
• Provided educational, research and scientific support to various project teams.
• Provide analytical technical support to manufacturing operations and CMOs.
• Ensured that my team followed FDA, cGMP and cGLP guidelines and SOPs (including 21 CFR 11).

Key Accomplishments

• In record timing, and as an FDA commitment under McNeil's consent decree, successfully completed method update projects (development, validation and transfers) for all products manufactured at two of McNeil's operating sites.
• 3Q2014 North America and OTC Consumer Eagle Award group winner for "achieving exceptional business results by demonstrating outstanding leadership behaviors."
• Following the acquisition of Pfizer Consumer Healthcare products, successfully integrated or developed analytical methods for incorporating them into the McNeil Consumer Healthcare portfolio (Key products included Zyrtec, Sudafed and Rolaids).
• Lead the most projects in the department which were on the president's annual top 10 list.
• Developed strategic initiatives to ensure cGMP and cGLP compliance while successfully transitioning to new processes.
• Developed project teams fostering peer collaboration making everyone accountable to each other and ensuring timely, well vetted project completion.
• Recognized as the McNeil Project Team of the Month by the leadership board for going above and beyond to keep project timeline promises.
• Received a Johnson & Johnson Global Standards of Leadership Award for achieving exceptional business results.

Team Leader, Analytical Research and Development, 2003 - 2005

• Provided support to marketed product projects for Pepcid AC, Tylenol Rapid Release Gels, Motrin, Imodium, Mylicon and Pancreaze.
• Managed the analytics of development from pre-formulation testing through product launch.
• Coordinated analytical testing for NDA filings.
• Managed a team of up to 30 professionals to qualify new manufacturing area products, and reformulated products.

Key Accomplishments

• Led Research and Development teams to meet aggressive timelines (i.e. supporting manufacturing facility start-ups, etc.) while ensuring cGMP and cGLP compliance for NDA filings.
• Selected contract testing sites for high volume projects and performed due diligence to confirm the quality of the work for internal stakeholders.
• Provided key updates from conferences attended in support of new technology initiatives.

Janssen Pharmaceutica (Johnson & Johnson), Senior Scientist, Quality Assurance, 2002 - 2003

• Supported QA and manufacturing functions through analytical techniques.
• Conducted product investigations on stability samples when required.
• Peer reviewed investigational research notebooks and reports.

Key Accomplishments

• Synthesized degradation products for positive confirmation.
• Resolved investigations using advanced lab techniques, prior to the launch of the Cypher drug eluting stent, made by J&J sister company.
• Cordis, supported analytical testing of launch build quantities at the San German, PR site.

Senior Scientist, Quality Assurance, 1999 - 2001

• Project Manager for the development and implementation of Near Infrared ( NIR ) technology.
• Presented and convinced other Johnson & Johnson operating companies to use NIR technology.
• Built the first spectral library, transferred it to the manufacturing plant, and trained first operators.
• Coordinated the alignment of NIR technology between Johnson & Johnson manufacturing sites.

Key Accomplishments

• Developed, validated, implemented and provided training classes for the new NIR technology.
• Designed, planned and set-up an organic synthesis lab within the QA department for use in resolving investigations.
• Created and co-chaired the First International Johnson & Johnson Near Infrared Symposium.
• Awarded Lightning Strikes individual service awards for accomplishments.

R. W. Johnson - PRD (Johnson & Johnson), Senior Scientist, Drug Evaluation, 2001 – 2002

• Evaluated drug substances and products for their development potential.
• Developed analytical test methods and impurity profiles ( HPLC, DryLab).
• Identified impurities and degradation products ( LC/MS, synthesis, UV-Vis, NMR).
• Performed solid state form characterization of drug substances ( IR, Raman, X-ray).

Key Accomplishments

• Contributed to the development of a standardized, high throughput, drug form screening process ( Gilson Liquid Handler, MultiMax, Raman spectroscopy).

Honors & Publications

Academic and Professional Affiliations

• Children’s Hospital of Philadelphia-Runway committee
• Healthcare Businesswomen’s Association- Market Research Committee, Chairperson of the Women in Science Committee
• Chairperson of the Corporate Analytical Subcommittee for J&J
• Vice-Chairperson of the Corporate Analytical Subcommittee for J&J
• Treasurer of the Corporate Analytical Subcommittee for J&J

Awards

• Healthcare Businesswomen's Association Chapter Excellence Award
• Johnson & Johnson North America and OTC Consumer Eagle Award
• Johnson & Johnson Global Standards of Leadership Awards

Publications

Author and Co-Author of scientific papers, peer reviewed articles, and education text .

Education

• Ph.D.  Organic Chemistry, University of Miami, Coral Gables, FL
• B.A.     Chemistry, Wesleyan University, Middletown, CT