Results-oriented Process Engineer known as a consistent team player with skilled technical abilities and detail-oriented with strong Pharmaceutical Science education background supported by research and professional work experience in manufacturing and engineering areas.
Areas of Expertise
Creative problem solving
Guidelines: EU, ICH, US FDA, GAMP5, PDA
cGMP, GDP, ISO standards, ISPE
Process Monitoring and Data Analysis
Root Cause Analysis
Process Assessment and Validation
Research and Work Experience
to Current Pharmalucence, Inc. (A Sun Pharmaceutical Company) – Billerica,
Served as a point of contact for technology and product transfers, engineering studies, and other transfer deliverables.
Worked on highly complex problems where instant evaluation and analysis of imperceptible glitch was required to continue ongoing project.
Established calibration and preventive standards, training materials, standard operating procedures relating to existing and new technologies.
Designed and executed process capability studies to mitigate routine technical issues encountered during manufacturing activities on the isolated filling system.
Responsible for creating and delivering training materials to users of Filling Technology, Sterilizers, Depyrogenation Oven, and Lyophilizers.
Reviewed equipment\'s P&ID, User Requirement Specification (URS), Functional Specification (FS), Design Specification (DS), Alarm matrix, and other documents as part of technical gap analysis exercise between equipment manufacturer\'s site and Pharmalucence.
Performed Factory Acceptance Test (FAT) of new isolator technology to demonstrate system meets approved specifications and operates as per the requirements of Pharmalucence.
Supported validation engineering group to prepare validation protocols in support of qualification activities of newly purchased isolator technology.
Responsible for working with the Original Equipment Manufacturers (OEM) to acquire knowledge on new products, resolve complex issues and develop preventive measures.
Provided subject matter expertise in support of process and equipment related critical events such as investigation, deviations, change controls, CAPA, DCRs.
Ensured equipment's are maintained in a cGMP compliant state at all the times.
Formulation and Fill Chemist10/2013
to 02/2016 Pharmalucence, Inc. (A Sun Pharmaceutical Company) – Billerica,
Developed detailed procedures (Batch Record, Summary Reports, SOPs, training documents, performance assessment checklist.) for the new processes and equipment's.
Assumed lead role in communicating and coordinating operation activities in absence of area supervisor, and trained operators on the new processes associated with advanced isolated filling technology.
Collaborated with R&D group to design and develop washer, sterilizer, depyrogenation oven process configuration and other formulation processes for the CBE-30 and new products to be manufactured.
Supported engineering groups to establish formal experimental plan to assess performance of new parts and components on the filling technology.
Identified and developed material specifications document for new raw materials and long-standing ones.
Completed final formulation of the drug product via aseptic technique.
Reviewed completed batch records, logbooks and SOPs in accordance with cGMP and GDP standards.
Interacted and supported other functional groups Validation, Quality Control, Quality Assurance, and Engineering
to 09/2013 Lonza Biologics, Inc – Hopkinton,
Purified recombinant proteins from end of
fermentation activities to bulk fill of product using small and large scale
chromatography systems (GE AKTA, Varian), tangential flow filtration (TFF)
including Ultrafiltration/Diafiltration and normal flow filtration.
columns ranging from 30cm to 80cm in diameter such as GE BPG, GE Chromaflow,
and Eastern Rivers (ERVB) columns, and calibrated laboratory equipment.
chromatography and qualification testing (HETP and Asymmetry) using Unicorn software
and manual calculations on packed column resin bed.
Reviewed, edited, and revised completed batch
records, logbooks, and SOPs in accordance with cGMP standards.
and documented all activities in compliance to Good Manufacturing Practice
(GMP) using following systems: Document Management System (DMS), Laboratory Information
Management System (LIMS), and SAP. Initiated deviations using Trackwise System.
Applied six sigma/lean manufacturing
principles to optimize efficiency within the manufacturing laboratory.
to 12/2010 Massachusetts College of Pharmacy and Health Sciences – Boston,
Compared the in-vitro drug release pattern for both brands of
Lansoprazole (one Rx and one OTC), and predicted the specific site of drug
release in the gastrointestinal tract via convolution.
Spectroscopic analysis via UV/Vis Spectrophotometer of
Lansoprazole was followed by HPLC analysis using X-Terra Column (Waters).
concentration time curve of the IV bolus was created to help with convolution.
Bachelor of Science: Pharmaceutical ScienceMay 2011Massachusetts College of Pharmacy and Health Sciences-
Certificate of Appreciation November 2014.
Inc. Award for Excellence July 2013.
Chuong M, Crosby S, Patel P, Alsulimani
H, Tan J, Valladares M, Ubhe A, Vo L. "In-Vitro Release of Lansoprazole Delayed-Release Capsules and
Convolution Study". Poster Session Presented
at: 14th Annual Meeting of American Association of Pharmaceutical
Scientists- North East Regional Discussion Group; 2011 April;
Rocky Hill, CT.