Contact Us

505-207-7740

U.S. Cit // Currently Mid Atlantic // Will relocate Greater NY/NJ area/East Coast
PhD Pharmaceutical Sciences // M.S. & B.S. Pharmacy
Formulation and process development of solid oral dosage form (sustained release, delayed release, immediate release, multi-particulate, orally disintegrating tablets, soft gelatin capsules), liquid dosage form (powder for solution, powder for suspension, sachets) and inhalation dosage form (Dry powder inhalation).

EDUCATION
Ph. D. Pharmaceutical Sciences
Specialization: Pharmaceutical Sciences
University of Maryland, School of Pharmacy, Baltimore, Maryland

R. Ph. – Registered Pharmacist
Licensed in New Jersey

M. S. Pharmaceutical Administration and Drug Regulatory Affairs
Specialization: Drug Regulatory Affairs – Took Classes
Arnold & Marie Schwartz College of Pharmacy and Health Sciences
Long Island University, Brooklyn, New York

M. S. Industrial Pharmacy
Specialization: Industrial Pharmacy
Arnold & Marie Schwartz College of Pharmacy and Health Sciences
Long Island University, Brooklyn, New York

Diploma in Marketing Management
Welingkar Institute of Management, Bombay, India

B. S. Pharmacy
University of Poona, Poona, India

Trained as a strategic thinker with problem solving skills and proven track record in management of projects across cross functional teams with successful regulatory filings and product launches. Contributed to the CMC regulatory submission (IND, NDA, ANDA, CTA, IMPD, and MAA) leading to successful filing, approval and launch of generic drug products and brand drug products. Brand products launched in the US market; ORAPRED ODT® (Prednisolone), SAVELLA® (Milnacipran HCl), and TUDORZA PRESSAIR (Aclidinium Bromide) AND in the EU market; EKLIRA® – UK (Aclidinium Bromide)

WORK HISTORY:

2006 to present:
January 2019 – present: Director, Research and Development (Formulation and Process)
• Lead the formulation group and direct scientific staff through various stages of the product development activities of complex generic and 505(b) 2 drug products. Product development activities include, pre-formulation, formulation development, process development, optimization and scale-up studies and technology transfer.
• Worked closely with business and portfolio group for product development strategy and ensured project timelines are met in line with department and company’s goals.
• Responsible for strategic decisions to design, develop and characterize robust drug product formulations to be dosed in clinical studies to advance through drug product development.
• Responsible for defining strategic regulatory filing timelines and preparation of the CMC sections of the ANDA submission.
• Collaborated closely with the analytical team to develop and implement specifications of the drug substance and drug product.
• Responsible for writing and reviewing technical and regulatory documents for submission.
• Responsible for drafting strategy to respond to any deficiency letter received from the regulatory agency either as information request (IR) or complete response (CR)
• Collaborated closely with in-house engineering team to procure and install new equipment, including IQ, OQ and PQ documentation and execution per regulatory agency guidance.
• Encouraged new ideas in process improvement to align requirements from the agency.
• Worked closely with the operations group to manage site transfer projects, scale-up and process development activities and served as a subject matter expert in support of new product launches, validation campaign(s) and routine commercial manufacturing.
• Worked with quality, operations and regulatory for continuous quality improvement, troubleshoot manufacturing issues observed during product launches or routine commercial manufacturing.
• Provided technical insight for response(s) to be filed with regards to any regulatory changes to be implemented post approval SUPAC changes i.e. CBE-0, CBE-30, CBE-90, or PAS
• Responsible for reviewing and implementing SOPs pertaining to the cGMP, product development activity (formulation, process, clinical), safety and DEA in accordance with the company policy.
• Monitored and appraised yearly performance of reporting staff

October 2013 – December 2018Associate Director, Research and Development (Formulation and Process)

• Developed overall drug product development and regulatory strategy for oral solid dosage and solution/suspension dosage forms in accordance with timelines set for regulatory filing
• Lead and direct scientific staff for the product development of complex generic products
• Directed product development activities for pilot and pivotal scale batches as per quality by design (QbD) approach i.e. use of risk assessment models, design of experiments and in-process control strategy to link critical material attributes and critical process parameters to critical quality attributes of final drug product.
• Directed product characterization studies in collaboration with preformulation/exploratory group in support of formulation development activities
• Lead role in interacting and collaborating with multifunctional departments like API supplier, analytical team leaders, intellectual property technical group and regulatory
• Provided guidance and oversight to internal and external product development to successfully deliver major milestones and file ANDAs in a timely manner
• Reviewed and authored module 2 and module 3 regulatory documents for the submission
• Reviewed clinical batch manufacturing documents like API specifications, Raw material specifications, Batch Manufacturing Record(BMR), Batch Packaging Records (BPR), In-Process Study Protocols, Stability Protocols, In-Process/Finished Product specifications and Packaging material specifications
• Reviewed product development reports, development protocols, information request (IR), complete response (CR) and CMC regulatory documents for ANDA submission

Senior Research Scientist June 2006 – August 2011
• Conducted formulation and process development of immediate/extended release solid and Inhalation (dry powder inhaler) dosage forms using the concept of quality by design (QbD) for development of a well characterized robust formulation
• Served as a Technical lead for preclinical formulation development of oral solid dosage formulation for toxicology and pharmacokinetics (bioavailability – mass balance study) studies
• Designed and evaluated experiments using investigational statistical tools (Design expert, Minitab)
• Directed, planned & managed technical staff for execution of projects for formulation and process development including troubleshooting via collaboration with multiple disciplines within the firm and with external development organizations
• Involved in successful scale-up and technology transfer activities of filed products to commercial production i.e. Milnacipran, Aclidinium Bromide
• Responsible for writing and reviewing technical documents including MBR’s, specifications, protocols, product development reports and appropriate sections of drug product CMC dossiers for regulatory submissions (IND/CTA/IMPD/NDA/MAA)
• Conducted due-diligence tasks for both external product development and business development

June 2002 – June 2006: Research Scientist, Formulation Development

• Designed immediate and extended release solid dosage forms for an existing marketed product (line extension)
• Designed and executed preformulation, excipients compatibility and stability studies
• Performed preliminary prototype formulation suitability and reliability evaluation study
• Responsible for writing process study protocols and manufacturing batch records
• Manufactured pilot/pivotal clinical and stability batches under cGMP guidelines to support sNDA (505b2)/ANDA filings
• Evaluated stability data of assigned products under development
• Responsible for process optimization, scale-up, technology transfer, process validation and writing development summary report
• Worked on several internal and external joint ventures, updated senior management and business partner periodically of the project progress
• Collaborated with multidisciplinary teams comprising analytical, quality, and manufacturing
• Drafted sections of regulatory documents (CMC documents) for client IND and/or sNDA filings
• Performed unit operations including fluid bed layering (taste masking), fluid bed coating, wet and dry granulation, Powder blending, tableting, roller compaction
• Hands on experience for developing taste masked product using granulation and Wurster based fluid bed technology

July 2000 – June 2002 Research Associate, Pharmaceutics Research and Development
• Investigated various techniques and excipients needed to develop oral immediate and controlled-release formulations for small and macromolecules utilizing proprietary technology based carriers
• Conducted physical characterization of proprietary carriers critical for oral delivery of macromolecular drugs
• Responsible for setting up and performing experiments designed to understand physical, chemical and mechanical properties of proprietary molecules, as well as analyzing obtained data, interpreting and summarizing results
• Responsible for setting up design of experiments to support research, formulation and technology transfer to contract research organization
• Interpreted In Vivo data obtained from the primate study and designed new study for improving the response
• Performed unit operation including granulation, powder blending, tableting and pan coating

January 2000 – June 2000 Senior Formulation Scientist, Pharmaceutical and Analytical Research and Development
Responsibilities included:
• Determined the feasibility of new product followed by laboratory development, characterization of formulations, and evaluation of in-vitro and in-vivo drug release data.
• Planned research and development activities for successive phases of problem analysis, and product development work of controlled release formulation using enteric coating polymers
• Hands on experience for developing controlled release formulation using extrusion-spheronization and hot melt granulation techniques for poorly soluble drugs
• Hands on experience for aqueous and non-aqueous enteric coating using Strea 1 – Aeromatic and Glatt GC-300

SCIENTIFIC ABSTRACTS/PROCEEDINGS AND PUBLICATIONS

PATENTS

FOR FULL RESUME CALL 505-207-7740 (MT) or email jobs@pharmaboard.com