Product Development Support

PROFILE

Detail oriented Analytical Scientist with 15 years of experience in Pharmaceutical R&D and cGMP regulated environments with excellent knowledge of ICH, cGMPs, GLPs and FDA guidelines. Fast learner, able to complete assignments flexibly and independently as well as in a team environment with excellent communication and documentation skills. Capable of managing several projects simultaneously and reprioritizing workload based on evolving timelines.

Performed method development, validation, clinical release and stability testing on key NCEs (New Chemical Entity) and Drug Products to support registration.

Experience with various dosage forms such as tablets, capsules, oral and topical solutions, injectables, suspensions, and medicated animal feeds.

Broad knowledge in HPLC method development: designed and executed experiments providing accurate results regarding drug potency, degradation, and impurity profile.

Interpreted and identified trends for data analysis.

Active in providing support in preparing OOS investigations and root cause analysis and in ensuring that CAPAs implemented appropriately to address the root causes of events.

Authored, reviewed, and verified regulatory sections, protocols, validation reports, stability protocols, SOPs, and technical reports and responded to FDA comments for submitted NDAs.

PROFESSIONAL EXPERIENCE

West-Ward Pharmaceuticals, Eatontown, NJ

Senior Chemist, Analytical R&D (Aug 2015- Feb 2017)

Provided analytical support

Developed and validated analytical methods in support of ANDA fillings on multiple projects of different complexities.

Performed drug substance and drug product method validation utilizing analytical techniques such as HPLC, dissolution, moisture etc.

Authored and reviewed experimental notebooks, analytical data, validation reports, procedures.

Conducted monthly safety inspections for housekeeping and compliance issues and communicate findings for corrective actions.

Catalent Pharma Solutions, Somerset, NJ

Scientist, Analytical Sciences (Jul 2014- Aug 2015)

Provided analytical support to late stage product development

Performed drug product release analysis, stability testing, and method validation utilizing analytical techniques such as HPLC, dissolution, moisture, density, disintegration, hardness etc.

Reviewed experimental notebooks, analytical data, validation reports, procedures.

Conducted monthly safety inspections for housekeeping and compliance issues and communicate findings for corrective actions.

Merck & Co., (formerly Schering Plough) Summit/Kenilworth, NJ

Scientist, Human Health /Animal Health (2006-2014)

Provided analytical support to late stage product development

Developed and validated analytical methods in support of NDA fillings on multiple projects of different complexities.

Performed drug product release analysis, stability testing, and method validation utilizing analytical techniques such as HPLC, dissolution, moisture, density, viscosity, water activity etc.

Prepared validation reports and summaries, stability reports and supporting documents for CMC submissions and for analytical technology transfer.

Provided support on Pre-Approval Inspection, and responded to regulatory agency inquiries.

Reviewed, audited and approved experimental notebooks, analytical data, validation reports, procedures, SOPs, and technical reports.

Trained other analysts in the use of established methods, instrument operation, and electronic lab notebook system.

Provided support in conducting out of specification laboratory investigations and in root cause analysis, by ensuring that CAPAs were implemented appropriately.

Recognized as a LIMS/Empower “Super User” and was instrumental in assisting the user community on a daily basis.

Led key initiatives involving process improvements and cross site harmonization of Empower 2 data system.

Conducted monthly safety inspections for housekeeping and compliance issues and communicated findings for corrective actions as a lead member of the Safety Inspection Team.

Supported metrology system simplification process as an author, technical reviewer, approver, and SOP administrator.

Reviewed and improved Summit Safety and Environment Project to address all aspects of chemical management as a team member of Chemical Management System.

Associate Scientist, Animal Health (2000 –2006)

Supported late stage product development as analytical chemist in drug product method validation, batch release, and stability testing in a cGMP/GLP regulated environment.

Developed and validated HPLC assay and determination of degradation product methods in medicated fish feed and swine feed in support of NDA fillings.

Prepared validation reports, stability reports and supporting documents for CMC submissions and for technology transfer.

Supported stability indicating studies by performing force degradation studies and identified impurities by using PDA detector and solid phase extraction as a sample preparation technique.

Participated in method trials for the CVM and GLP studies on different Animal Health projects.

Provided support on PAI and responded to the FDA comments for submitted NDAs.

Performed calibration and maintenance of analytical instruments.

Served as backup system administrator and assisted with upgrade for the Millenium-32 system.

Performed UAT (user analytical testing) testing for LIMS system validation and Millennium-32 Data Acquisition System.

Supported Value Enhancement Initiative by managing office and laboratory supplies and commonly used solvents for laboratory use.

Assisted in different audit and inspection readiness programs such as PAI, Regulatory, Environmental and Safety.

EDUCATION/PROFESSIONAL DEVELOPMENT

MS, Marathawada University, India

Empower 2 Apex Track Training

Waters Millennium 4.0 Fundamentals Course and PDA Training

Introduction to GLPs

SKILLS

Excellent knowledge of data management software for Waters Millennium-32, Empower2, LIMS (Laboratory Information Management System) and ELN (Electronic Lab Notebook) and Empower/LIMS Interface.

Microsoft Office Suite: MS Word/Excel, Microsoft Publisher and Microsoft Power Point.

AWARDS

Special Achievement Award for supporting the on-time delivery of Vorapaxar NDA CMC dossier.

Special Achievement Award for high degree of leadership, technical contributions, and above-and-beyond level of effort for successful development of Vorapaxar.

Award for Excellence for outstanding performance for above-and-beyond input and insight for Empower harmonization team.

Award of Appreciation for maintaining lab/office supply cabinets as a Value Enhancement Initiative.

Recipient of Lean Six Sigma Yellow Belt.

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