Large/Small Molecule Development, FDA Compliance, and CAPA Investigations Biopharmaceutical Analytical Expert

Expertise

• Creating lean analytical departments with significantly improved efficiency and turn-around-times. Organizational effectiveness and culture improvement
• Strategy and execution for concurrent large-scale projects.
• Biologics (large molecules); small molecule development and analytical development.
• Research and development executive management; project program management and validation and qualification.
• CAPA; investigations; drug product development and transformational leadership.
• CMC expertise: IND, BLA, NDA, 510K, PMA, ANDA, quality and FDA compliance.
• FDA and other agency negotiations.

Experience

Undisclosed Company, President and Managing Partner, Present

• Consultant to the FDA regulated industries. Working with clients as their global SME (Subject Matter Expert) in research and development productivity and efficiency enhancement with specialization in laboratory compliance.
• Service bio-pharmaceutical companies to obtain fast approval of their products by the U.S. FDA and other worldwide agencies.
• Providing compliance and lab productivity training and seminars worldwide.

Bristol Myers Squibb, Hopewell, NJ, 2013 - 2014

Executive Director, Analytical Development and Testing (Biologics)

• Overall management of analytical research and development for industry-leading pipeline of novel Biologics with a budget of $45 million and staff of over 200 analytical scientists, at five sites in BMS research and development network located in three states (NJ/NY/MA).
• Sponsored Kaizen project to reduce cycle time of clinical lot release and benchmarked and instituted biologics development best practices.
• Initiated and led international collaboration on global improvement initiatives of process, technology and culture change by automation, IT and Process Initiatives across all relevant corporate business unit locations worldwide.
• One major BLA on target for break through Oncology product, OPDIVO (Nivolumab), FDA-approved in December 2014.
• Led timely completion of Health Authority (HA) Post-Marketing Commitments (PMCs) and Follow-up Measures (FUMs) for BMS Biologics commercial portfolio.
• Rapidly transformed Biologics Analytical Research and Development organization into world-class entity.
• Streamlined operations to support accelerated research and development programs.
• Championed cross-functional productivity initiatives promoting automation, IT, and lean processes resulting in reduced clinical lot release cycle time by five-fold from vial thaw to Certificate of Analysis (COA).
• Directed recruiting of nearly 70 experienced personnel from across Biotech industry.
• Led teams to submission of successful filings (e.g. BLA, MAA, IND, IMP) on aggressive timelines by building worldwide collaborations and creating inclusive environment.
• Conceived, justified and enabled board approval of $35 million for a brand new consolidated NJ site.

TEVA Global Branded Research and Development, (Cephalon), West Chester, PA, 2006 - 2012

Senior Director, Analytical Sciences (Small Molecules, Biosimilars and Biologics)

• Headed all Analytical Sciences functions including GLP/GMP release and stability testing for small molecule and biologic products from pre IND to NDA/BLA including life cycle management.
• Oversaw and managed design, construction and commissioning of new GMP laboratories and stability facilities, including biologics-focused laboratory and high potency suite.
• Significantly improved GxP compliance by establishing a compliance function and enhancing overall quality system, including training, documentation and investigation procedures.
• Collaboratively partnered with variety of worldwide multisite departments to provide timely CMC sections for regulatory filings.
• Managed laboratory operations through successful audits and inspections, including those by Teva Corporate auditors, internal QA, DEA, EU QP and DEP.
• Developed, and implemented automated global data management systems such as Empower, Nugenesis and Lab-ware.
• Augmented core staff by hiring best-in-class personnel with the right credentials. Enhanced efficiency and productivity of laboratory operations through process improvements, personnel management and automation. Created model PD departments.
• Site became a corporate pride showcase with brand new versatile GMP laboratories with flexibility being emulated by other Teva sites.
• Fine-tuned organizational structure to improve morale, efficiency and promote individual growth resulting in meeting and often exceeding aggressive timelines to NDA/BLA approval.
• Zero turnovers even during ambiguous and difficult Cephalon/Teva merger period proving my mentorship.
• Zero major observations in six years.
• Research and development productivity doubled within second year. Accelerating lab turnaround time fivefold within three years.
• Traditional regulatory filings time was cut in half (e.g. IND, IMPD, NDA, BLA, MAA).
• Globally established rapport and credibility with peers, SMEs, senior leadership and functional leaders at multiple levels resulting in smooth PD operations and customer satisfaction.

Baxter Health Care Corporation, Cherry Hill, NJ, 2002 - 2006

Director, Research, Anesthesia, Critical Care and Oncology, 2003 - 2006

Sr. Global Project Manager, Baxter Transfusion Therapies, Round Lake, IL, 2002 - 2003

• Directed research and development of parenteral products at worldwide facilities including global development partners. Integrated multi-site, multi-culture corporate research teams at newly acquired units into Baxter culture.
• Increased productivity with optimized staff. Directed IND, NDA, sNDA and ANDA submissions. Managed budget (of over $12.3 million).
• Negotiated outsourcing deals and contracts and managed execution of portfolio/programs. Made final business recommendations by comparing potential partner companies and selecting proper deals on global basis saving $3 million of research and development dollars.
• Expedited Baxter's entry into European market for novel pathogen Inactivation product. Saved $2 million in product costs.

All-Natural Health Foods Inc., President and Founder, 1998 - 2001

• Founded own company for distribution and marketing of natural medicines and vitamins. Profit and Loss responsibility.
• Doubled second year sales to over $1 million.

Aventis Behring LLC, Parenteral Biopharmaceuticals Division, Kankakee, IL, 1996 - 1998

Director, Quality Control and Analytical Development

• Led several Project Teams to resolve quality and FDA compliance issues within Quality Control in four months for $1 billion human plasma products plant under FDA consent decree.
• Directed four departments including Biology, Chemistry, Microbiology and Stability. Presented to Board of Directors and successfully justified resources for Quality Control personnel and automated QC capital equipment.
• Shipped products six months earlier than anticipated, improving cash flow and bottom line.
• Steered QC departments through FDA consent decree and received fast clearance for QC labs.
• Modernized and automated QC releasing products efficiently with reduced cycle time and stock outs increased compliance and profits.

Bristol-Myers Squibb, New Brunswick, NJ, 1987 - 1996

Manager of Research and Development, CMC Project Leader, 1991 - 1996

• Led development coordination teams, for INDs and NDAs.
• Led company-wide drug development team to file IND for new cardiovascular drug nine months earlier by using parallel processing.
• Managed special technology group engaged in IC, Pulsed Electrochemical Detection (PED), SFC and SFE, CZE and Capillary Ion Analysis (CIA).
• Managed central AA lab performing AA, ICP, ICP-Mass Spectrometry and IC-ICP-MS. These unique groups served as 'swat' teams.
• Led integration team to create efficient post-merger research and development department of over 270 personnel from two major corporations, Bristol-Myers and Squibb, with six global sites.
• Filed NDAs and INDs ahead of schedule. Saved nine months of development or $37.4 million.
• Expedited drug development, reducing filing timelines establishing a new corporate standard.
• Won Bristol-Myers Squibb President's award for outstanding achievement in Project Management.
• Improved productivity and synergy. In the first year, the merged department's NDAs and INDs doubled.
• Helped senior management to smoothen a mega merger and delivered timely results.

Senior Research Investigator, 1989 - 1991

Research Investigator, 1987 - 1989

• Patented new supercritical extraction procedure for Taxol, over $3 billion a year cancer drug increasing yield from Pacific Yew bark.
• Devised analytical techniques for monoclonal antibody derived site-specific targeted drugs.
• Created, nurtured and managed specialized assay development lab.
• Reduced development time Taxol by three months saving $2.9 Million.
• Facilitated company's foray into new ADC technology and new franchise.
• Delivered fast and efficient testing methods saving 110 man-hours for six assays and costs.

Thermo Analytics Group, Riviera Beach, FL, Senior Applications Chemist, 1985 - 1987

• Managed the applications laboratory. Led research in new HPLC, IC, and SFC & SFE techniques to solve pharmaceutical and biotech customer problems.
• Collaborated with Dow Chemical Central Research. Made keynote presentations enhancing the new product's exposure.
• Reduced material costs by 66% and increased sales. Improved Company's bottom line.
• Enhanced sensitivity of detector 100 fold by miniaturizing electrode and improving signal to noise ratio.

Waters Associates, Millipore Corporation, Milford, MA, Research Assistant, 1982 - 1984

• Developed and characterized new packing materials for the analysis and purification of proteins and peptides.
• Created new products for emerging biotechnology industry. Gained valuable expertise.

Honors & Publications

Credentials

PMP, Project Management Professional, Project Management Institute, PA

Academic and Professional Affiliations

• Project Management Institute (PMI)
• International IC Symposium Committee & Parenteral Drug Association (PDA)
• American Association of Pharmaceutical Scientists (AAPS) and CMC Leadership Member, USP Committee

Education

• Ph.D. Pharmaceutical Analysis by IC & HPLC, Boston University, Boston, MA
• M.A. Computer Interfacing in Analytical Chemistry, Boston University, Boston, MA
• M.Sc Solid State NMR, Indian Institute of Technology, Kanpur, India