Product Manager | Operations & Data-Driven Products | Life Sciences
Iselin, New Jersey, United States of America
Product Manager | Operations & Data-Driven Products | Life Sciences
Iselin, New Jersey, United States of America
Work history
Copart
Gilead Sciences
Immunomedics
Par Health
Par Pharmaceutical
Hovione
GSK
Merck
Firmenich
Lehigh University
Drew University
APR 2025 - PRESENT · 1.3 years
Senior Product Manager
APR 2025 - PRESENT · 1.3 years
NOV 2020 - APR 2025 · 4.5 years
Senior Process Engineer, Global Biologics Tech Ops
JAN 2022 - APR 2025 · 3.3 years
Process Engineer III
MAR 2021 - FEB 2022 · 1 year
Process Engineer
NOV 2020 - MAR 2021 · 5 months
FEB 2020 - OCT 2020 · 9 months
Process Engineer
FEB 2020 - OCT 2020 · 9 months
FEB 2019 - FEB 2020 · 1.1 years
Process Engineer
FEB 2019 - FEB 2020 · 1.1 years
SEP 2017 - FEB 2019 · 1.5 years
Process Development Associate
SEP 2017 - FEB 2019 · 1.5 years
- Plan and execute pilot scale manufacturing processes for scale up and process validation studies. - Standardize the existing manufacturing processes (both equipment and steps) to increase robustness and compliance. - Develop and implement optimization experiments to improve existing processes. - Troubleshoot and resolve manufacturing process problems—determining root cause and corrective actions. - Develop process documentation and training material to support the standardized processes and new product launches. - Provide requested documentation to support compliance requirements for existing products and for new product regulatory filings. - Working as a member or leader on the technology transfer team, transition new products into production to ensure that the new product meets production, quality, and compliance requirements. - Provides manufacturing process leadership through process improvement and optimization. Initiate and conduct validation of production processes and test equipment. - Coordinate activities with Manufacturing and Pharmaceuticals technology teams to ensure proper prioritization. - Design and interpret technical studies and data in order to resolve technical issues encountered during each project. Help define technical objectives and convey them to the other members of the project team. - Plan manufacturing processes, based on small scale procedures, with the goal of running safely and efficiently in the pilot plant whilst ensuring cGMP compliance - Work on plant floor with the Technicians, Plant Manager, Supervisors, Engineering and other staff to troubleshoot technical problems in manufacturing, packaging equipment or process problems in production areas. - Author and Review technical protocols, SOPs and technical reports.
JUN 2016 - SEP 2017 · 1.3 years
Process Engineer
JUN 2016 - SEP 2017 · 1.3 years
- Planned manufacturing processes, based on small scale procedures, with the goal of running safely and efficiently in the pilot plant whilst ensuring cGMP compliance - Worked on plant floor with the Technicians, Plant Manager, Supervisors, Engineering and other staff to troubleshoot technical problems with manufacturing or packaging equipment or process problems in production areas. - Coordinated the scale up of API projects from laboratory into the pilot plant and beyond. - Trained Production personnel on the use of production systems and procedures. - Organized and contributed to the Process Hazard Analysis (PHA) of all processes under my responsibility and assured that identified hazards were addressed prior to performing any activities at scale. - Worked with purchasing and warehouse to ensure that raw materials and production supplies were available prior to manufacturing as per schedule. - Prepared mass balance sheets, instructions for unit operations, production batch records, bill of materials and other GMP related documentation for all processes run in Production. - Prepared scientifically sound reports (campaign, monthly, deviation investigation, etc.) in a timely manner. - Assisted in the preparation of technology transfer packages and technology transfers of processes/products either to the company or the client’s facilities. - Planned and designed methods to improve process efficiency in production. - Authored and Reviewed Technical protocols, SOPs and technical reports.
JUL 2015 - JUN 2016 · 1 year
Chemical Process Engineer
JUL 2015 - JUN 2016 · 1 year
- Worked on process definition and delivery of active pharmaceutical ingredients (API) or composite materials with properties that enable robust simplified formulations. - Performed hands-onoptimization and scale-up of the chemical unit operations to deliver robust manufacturing processes. - Participated in technical process reviews and identify critical process characteristics and requirements as well as existing plant capabilities and limitations by gathering and interpreting suitable experimental data. - Performed laboratory scalestudies with organic chemists, formulators andplant engineers - Identified and effectively communicated the best scale-up strategy for processes including recommendations for the application of processing technologies. - Developed semi-batch crystallization process for a continuous process - Generated solubility curve, phase diagram, model crystallization path, range finding studies, impurity spiking studies and scoping work - Identified the key components in the process using analytical chemistry techniques such as HPLC, DSC, GC
JUL 2014 - JUL 2015 · 1.1 years
Associate Engineer
JUL 2014 - JUL 2015 · 1.1 years
- Performed research goals related to process development, technology development, and production of active pharmaceutical ingredients (API). - Performed hands-on process development and scale-up work consisting of scales ranging from laboratory to commercial. - Performed material balance for various separation processes to determine the yield after each step in the process scheme. - Analyzed the key components in the process using analytical chemistry techniques such HPLC, DSC, SEM.
FEB 2014 - JUL 2014 · 6 months
Intern - R&D
FEB 2014 - JUL 2014 · 6 months
GC-MS analysis and data interpretation of samples Quality Control Data Management Design of Experiments (DOE)
MAY 2012 - AUG 2012 · 4 months
Research Experience for Undergraduates (REU) intern
MAY 2012 - AUG 2012 · 4 months
As a REU intern in the Lehigh University Physics department, I was responsible for characterizing single-wall carbon nanotubes for dielectrophoresis. By using fluorescence spectroscopy, a PL/PLE map was created to identify various types of nanotubes in a mix sample. Furthermore, absorption spectroscopy was used to verify PL/PLE map. Skills learned during this internship, - Spectroscopy (PL/PLE, absorption) - Dielectrophoresis - Fluorescence spectroscopy for Rare earth elements
JUN 2011 - AUG 2011 · 3 months
Research Intern
JUN 2011 - AUG 2011 · 3 months
As a research intern in the Drew University Physics Department, I was responsible for understanding and designing a Raman spectroscopy setup. My goal as a research intern was to design a spectroscopy setup sensitive enough to study a complicated organic molecules such as Disperse Red 1 (organic dye). During this internship, I learned - spectroscopy (Raman, IR, Fluorescence, UV) - calibrating and troubleshooting analytical instruments - Concentration studies - Gaussian Analysis
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