Associate Director

• May 2022 - Present

Senior Engineer/Manager

• Jul 2019 - May 2022

Project Manager

• Jun 2013 - Jun 2019

Provide strategic planning, organization, direction, and tracking for completion of multiple development (R&D), clinical and commercial pharmaceutical projects. -Proactively manage cross-functional teams to assure timely completion of project activities -Review validation protocols (IQ/OQ/PQ) and final reports, Validation Master Plans, and Master Plan Summary Reports for equipment and processes. -Oversee validation and re-validation studies for protocol compliance. Provide Validation Subject Matter Expertise for the organization. -Proficient in equipment and facility qualification. - Lead project kickoff meetings, issue agendas, provide meeting minutes, and follow up on the action items. -Continuous communication with stakeholders to understand their needs and expectations, addressing issues as they occur, managing conflicting interests, and fostering stakeholder engagement in project decisions and activities -Determine and identify raw materials, equipment, and human resources. -Author, execute, and review validation and re-validation (IQ/OQ/PQ) protocols for facility, utilities, and manufacturing equipment. - Author and execute re-qualification protocols when a piece of equipment has been repaired/updated. -Expertise in developing and reviewing validation master plans, master plan summary reports for production facilities. Compile validation packages and assure all required documentation is accurate and complete. -Expertise in process, product, and cleaning validation. -Expertise in process analysis and risk analysis. -Review, analyze, and interpret system performance data for completed qualifications and prepare final summary packages. -Expert knowledge in FDA, EU, and ISO regulations. -Experience with FDA and EU audits (commercial products) -Provide technical assistance to clients in the preparation and submission of NDAs and ANDAs -Assure all processes are in compliance with CGMP, CGLP, ICH, EMA, and DEA regulations and guidelines Show less

Intern- Formulation

• May 2012 - May 2013

1.Assist the project team with the characterization of powder flow physical properties under dynamic conditions in a rotating drum2. Study on polymer/API blends on lab scale to understand segregation to address content uniformity issues during process scale up3. Optimize the selection of excipients Using DOE

Intern

• May 2012 - Aug 2012

1. Assisted the project team in the development of a new controlled release combination product using Hot melt extrusion technique. Understood the properties of various polymers (excipients) and their suitability to the Extrusion process.2. Assisted with solid dosage form development including monolithic tablets, bilayer tablets, capsules, polymer matrix formulations, controlled release tablets and combination products.3. Hands on experience with fluid bed granulation, wurster coating, tablet and capsule manufacturing, roller compaction, hot melt extrusion and high shear granulation, working in a variety of laboratories as well as the Pilot Plant.4. Participated in preclinical large animal studies involving pharmacokinetic profiling, use of gamma isotopes, gamma scintigraphic imaging and capsule endoscopy 5. Performed forced degradation studies to test the stability/compatibility of excipients.6. Validate a new dissolution technique using peristaltic compression of dosage forms to simulate in vivo conditions.7. Stability and solubility testing using HPLC8. Assisted with particles characterization and quantification using hot stage microscopy, x-ray diffraction, differential scanning calorimetry, thermal analysis and FTIR for projects in different groups. Show less

Student

• 2011 - 2013

Master's Research Project: Formulation and Optimization of Controlled Release Naproxen Sodium Matrix tablets using Kollidon SR as a primary rate retarding polymer. Graduated with Honors ( Magna cum laude ) Master's Research Project: Formulation and Optimization of Controlled Release Naproxen Sodium Matrix tablets using Kollidon SR as a primary rate retarding polymer. Graduated with Honors ( Magna cum laude )