Key Areas of Expertise
- Quality Systems Development and Compliance
- Equipment and Cleaning Validation
- Process Management and Innovation
- Technology Transfer and Scale-up
- Project Management and Team Leadership
- FDA Compliance and Audit Preparation
Professional Experience
Consultant – Pharmaceutical Manufacturing
Various Locations | 2010-Present
- Sagent Pharmaceuticals, Schaumberg, IL (Aug 2021-May 2022): Developed Process Control Strategy for Sagent’s CMO in South Korea, led QA reviews, and implemented improvements to batch records for GDP compliance.
- Sanofi Genzyme, Framingham, MA (Oct 2020-Aug 2021): Conducted QA investigations to address and eliminate backlog, led Root Cause Analysis meetings, and implemented corrective actions.
- KVK-Tech, Newtown, PA (Mar 2020-Jul 2020): Part of a remediation team, completed gap analysis on 350+ CAPAs and investigations, recommending procedural improvements.
- Pfizer, McPherson, KS (Sep 2017-Dec 2019): Led aseptic process improvement initiatives, secured funding for CAPA implementation, and managed Change Control projects in Trackwise.
- Pharmachem (Gilead CMO), Freeport, Bahamas (Dec 2016-Jun 2017): Authored site validation plans, SOPs, and qualification protocols to enhance validation compliance.
- Xellia, Cleveland, OH (Jul 2016-Oct 2016): Led OQ of packaging lines and supervised execution of protocols with a six-engineer team.
- Teva, Budapest (Mar 2016-Jun 2016): Authored qualification protocols for aseptic equipment.
- Mylan, Nashik, India (Nov 2015-Jan 2016): Developed SOPs and protocols for Continued Process Verification for Metoprolol ER.
- Pfizer (Meridian), St. Louis, MO (Jun 2015-Nov 2015): Conducted investigations within Trackwise for root cause analysis, resulting in CAPAs that prevented issue recurrence.
- Novartis CMO, Durham, NC (Sep 2014-May 2015): Authored URS, FRS, DS, and IOQ protocols for manufacturing and utility equipment, adhering to cGMP standards.
- Impax, Hayward, CA (Nov 2013-Jun 2014): Executed IQ/OQ for facilities and prepared qualification reports for utilities.
- Novartis, Lincoln, NE (Mar 2012-Oct 2013): Part of validation leadership, reviewed Site Validation Master Plans, and prepared protocols for shared utilities and packaging equipment.
- Piramal Critical Care, Bethlehem, PA (Jun 2011-Mar 2012): Led equipment design, procurement, and process flow establishment for a new anesthetic drug product.
- Bristol Myers Squibb, Devens, MA (Nov 2010-Jan 2011): Completed validation studies for autoclaves at a new plant.
Senior Manager, Process Engineering – Verenium Corp.
Cambridge, MA | 2008-2010
- Led propagation operations for a biofuels demonstration plant, managing critical phases of enzyme production, coordinating with R&D, and achieving capacity doubling to meet production targets.
Technical Manager – Pfizer, Inc.
Groton, CT | 1992-2008
- Directed quality improvement initiatives, including Six Sigma projects for Draxxin production, achieving $1.25M in annual savings, and optimized production processes for environmental compliance and RFT initiatives.
Process Engineer – Novacor Chemicals
Leominster, MA | 1991-1992
- Executed process improvements during maintenance shutdown, achieving significant cost savings and implementing a zero-discharge process for wastewater recycling.
Project Manager – Herdillia Oxides & Electronics
Bombay, India | 1989-1990
- Managed equipment selection and environmental agency coordination for a joint venture in magnetic iron oxide production.
Education
Master of Business Administration – Operations Management
Indian Institute of Management (IIM), Calcutta
Bachelor of Science – Chemical Engineering, Honors
Indian Institute of Technology (IIT), Bombay
Certifications and Training
- Six Sigma Green Belt
- Training in Statistical Methods, Operations Management, Project Management, and Drug Development