Pharmaceuticals Development Validations, Troubleshooting, Remediation, Resolution of OOS, FAR, and CAPA, FDA Responses, and Data Integrity

Expertise

• Drug product development: Global leadership to analytical teams responsible for developing and sustaining drug products from development, registration stability, regulatory submission, and commercial launch.
• CRO management: Direct Global teams responsible for strategic alliances with Indian CROs (200 FTEs for new products and product sustenance) with an annual budget of about $14 million
• Analytical: Method validations, troubleshooting, and SOPs using a variety of techniques such as UPLC, HPLC, GC, IC, SEC, GPC, AA, ICP-MS, ICP-OES, pH, and wet chemistry for both small and large molecules.
• Quality: Compliance with compendia, cGMP, cGLP per FDA and EMA requirements and remediation work. Lead teams to resolve Data Integrity, CAPA, OOS, and OOT issues.
• Operations: Green Belt and Lean Six Sigma thought processes and KPI metrics to improve efficiency and productivity (dramatically improved on-time completion rates moving from a 35% baseline to over 85%).
• Regulatory: Authored CMC sections for FDA and EMA submissions and defended CMC sections during regulatory audits.
• Outreach: Organized workshops and sessions at National meetings for PITTCON and AAPS. Author of over 30 peer reviewed articles and book chapters.

Experience

Undisclosed Company, Principal Consultant, Present

• Solve pH issues and developed SOPs on IQ/OQ/PQ for this consulting pharmaceutical and biopharmaceutical company.

• Material control and release, on site visual inspections, and shipping for producing clinical trial materials.

Baxter Healthcare Corporation, Round Lake, IL, Director, 2002 - 2018

Positions Served

Director - Project Management, 2007 - 2018

Senior Research Scientist and Research Scientist, 2004 - 2014

Senior Research Associate, 2002 - 2004

• Disciplined strategies transformed the relationship into becoming one of the best CRO relationships within Baxter with an annual saving of $5 million.
• This role changed to expanded to manage CRO in medical devices (about 400 FTEs).
• Management of CRO's in India with responsibility for over 200 FTEs.
• Identified and established vision and strategies for collaborative success.
• Removed barriers and established engagement and governance cadences and processes to deliver consistent success. Resolved CAPA issues.
• Applied continuous improvement approaches (LEAN and Green Belt) and key performance indicators to drive efficiency and improve productivity.
• Established productivity measurements; parameters studied for study driven work and number of tests for routine stability work.
• Set precedents for partnership that were then recognized for success and redeployed in other projects.

Key product sustenance projects completed at the CRO:

• Gap assessments and validations of about 400 test methods for about 140 reference standards.
• Characterization and worldwide supply of reference standards, transfer of test methods for about 350 research and development and commercial stability batches.
• Approximately 40 compounding studies, verification of about 30 compendial methods, and analytical method validations for 5 injectable products.
• Implemented Analytical Quality by Design approaches to improve operational efficiency.
• Built a professional network both internal stakeholders within business unit, across units, and outside of Baxter
• Analytical lead for Baxter's new and line extension products. Unique skills allowed for Analytical Quality by Design (AQbD) techniques to be applied to over 15 methods. Collective result of technical skills and operational acumen delivered increased operational efficiencies, robust method development, and helped move products to market faster while delivering over $20 million per year of revenue.
• Led analytical development from feasibility studies, clinical trials, through stability batches and commercial launch for several injectable drug products (clients and in-house programs in glycemic control, antibacterial, anti-infective, cardiovascular, oncology, Renal, pain and fever reduction areas. Expertise in technology transfer to manufacturing plants. Expert in cGMP, and knowledgeable in GLP and GCP.
• Authored analytical CTD sections for IND, NDA, 505b2, ANDA, and CBE filings, and defended them at the regulatory reviews by FDA and EMA.
• Developed analytical methods using HPLC, IC, SEC, and UPLC to solve analytical challenges in Research and Development, manufacturing plant, and stability labs.
• Directed innovative solutions such as calibration of SEC method for Dextrans, AccQ-Tag UPLC for amino acids, and analytical QbD.
• Led teams responsible for conducting gap assessments of existing analytical methods against the current regulatory expectations (compendia, FDA, EMA, and others), and bringing the methods into compliance.
• Evaluated compendial methods and implemented them with necessary modifications.
• Serves as subject matter expert for supplier quality audits in Europe, China, and India.
• Organized workshops on ion chromatography, compendial, regulatory guidance and AQbD at PITTCON and AAPS national meetings.

Cedarburg Pharmaceuticals, LLC, Grafton, WI, 2001 - 2002

Senior Analytical Chemist, Quality Control Department

• Working with formulation chemists, developed methods for new drug substances and intermediates.
• Validation of GC and HPLC methods.           

Lachat Instruments, Milwaukee, WI, Director, 1992 - 2001                                                                                                                   

• Hired as Applications Chemist, then promoted to Separations Manager following promotion to Product Manager and Director, Chromatography Development.
• Developed ion chromatography product line, in commerce.
• Developed Flow Injection Analysis methods and products, also in commerce.

University of Wisconsin, Department of Chemistry, Milwaukee, WI, Instructor, 2002 - 1998

• Lecturer-Instructor for graduate level course "Advanced topics in Analytical Chemistry, Chromatography."                 

Achievements

• Directed a Global Baxter team (U.S.A, Europe, and India) to lead strategic alliances with Indian CROs (200 FTEs working on new products and product sustenance) with an annual budget of about $14 million.
• Built successful global teams that are supported by clear goal and strategy communication, professional development, and individual and collective mentoring engagement.
• Developed strategies, continuous improvement programs, and metrics approach, and harnessed collective insight to deliver consistently successful teams, projects, and multi-million dollars of cost-savings.
• Led Global analytical research and development programs for new and line extension products from development stage through registration stability, regulatory submission (FDA and EMA), commercial launch, and life cycle management.
• Highly experienced in leadership to solving analytical challenges across multiple geographies.
• Collective result of technical skills and operational acumen delivered increased operational efficiencies, robust metric development, and helped move products to market faster while delivering over $20 million per year of revenue.
• Expertise in compendial compliance and compliance with cGMP and cGLP per FDA and EMA requirements.
• Led analytical teams to resolve CAPA, OOS, and OOT issues.
• Implemented KPIs to monitor and improve quality outputs.
• Effectively applied Green Belt and Lean Six Sigma thought processes and metrics to improve efficiency and productivity resulting in significant project scale-up KPI's and dramatically improved on-time completion rates moving from a 35% baseline to over 85% in less than two years.
• Successfully implemented KPIs to monitor and maintain efficiency and productivity at a high level.
• Organized workshops and sessions at National meetings for PITTCON and AAPS. Author of over 30 peer reviewed articles and book chapters.
• Participated in IQ Consortium Analytical Working Group to complete key projects and publish the work on Method Comparability and Analytical Quality by Design.

Honors & Publications

Credentials

• Lean Six Sigma and Green Belt " Situational Leadership " Feedback and Coaching through Management Essentials " Building Business Acumen through Management Essentials " Confidently Crafting and Presenting the Story

Languages

• Hindi:
• Marathi

Academic and Professional Affiliations

• American Association of Pharmaceutical Scientists (AAPS)

Awards

• Baxter Healthcare (numerous awards)

Publications and Patents

• Author and Co-Author of numerous publications and presenter.                 
• Provides domestic and international seminars
• 1 U.S. patent.

Education

• Ph.D. Ion Exchange Chemistry, Utah State University, Logan, UT