RICARDO LEWIS

** ****** ****** *** *

Groton, CT 06340

phone #: 917-***-****

email: actf4s@r.postjobfree.com

OBJECTIVE: Looking for a process and/or process development engineering position. Willing to relocate if necessary.

EDUCATION: Master of Science in Biochemical Engineering May 2017

New Jersey Institute of Technology (NJIT), Newark, New Jersey

Bachelor of Science in Chemical Engineering May 2011

University of Connecticut (UConn), Storrs, Connecticut

ACADEMIC PROJECT: Capstone Senior Design for UConn Chemical Engineers/Aug 2009-May 2010

Title: Large Scale Production of Monoclonal Antibodies for Anti-Cancer Treatment

Used single-use bioreactors, ranging from 5L to 20000L. Growth and scale-up of T-flask, shake flask, and roller bottle cell cultures. Analyzed nutrients, metabolites, and cell groups to monitor oxygen, CO2, pH, and temperature

Designed bioreactor sizes (pilot to production scale) using a chemostat model with Monod kinetics and process flow diagrams (FPD) for WFI, SIP, and CIP for mAb facility.

Calculated the yield of mAb product from downstream processing using bench-scale protein purification, including centrifuges, filtration(tangential flow and ultrafiltration) and column chromatography(IEX, Affinity).

Knowledge of 21 CFR and FDA regulations and incorporated cGMP practices for writing validation master plan for IQ,PQ, and OQ. of mAb facility.

PROFESSIONAL EXPERIENCE:

Precision Castings Corp:

Rework Engineer, Nov 2014-present

Groton, Connecticut

•Report any nonconformance on applicable MRB, (QN, MRB, Concessions) using GD&T

•Perform internal audits and issue CARs for findings, submit objective evidence of CAPA to customers

•Create work instructions and routings for processing of products referencing customer specs and Blueprints

•Initiate stop works to any non-conforming product to prevent escapes

•Submit annual layout packages (PAR, FAI, 56c, PSIP) to validate production of castings.

• DQR certified for Pratt & Whitney products

• Utilize PPAP for qualification of part manufacturing operations for new product initiatives (NPI)

Merck:

Product Development Engineering Intern, March 2012-Aug 2012

Summit, New Jersey

Support the formulation, process, and analytical development of high priority drug candidates

Design and perform studies to characterize key physical and chemical properties (CQA) of pharmaceutical materials(i.e. API) and/or formulated drug products

Through design of experiments (DOE) determined the critical process parameters (CPP) that affected the particle size distribution (PSD) using near infrared spectroscopy NIRS and LabVIEW

Using process analytical technology (PAT) to validate overall manufacturing of dry powder inhalers (DPI) based on critical quality attributes (CQA) such as PK/mass transfer rate constants and chemical pathways

United Technologies Corporation Power:

Process Engineer Intern, June 2010-May 2011

South Windsor, Connecticut

Led the FAT & SAT of an In-house manufacturing facility for bipolar plate fabrication

Performed machine readiness review to qualify machine for production purposes.

Using Minitab to create DOEs and created work instructions for future operators. In addition, utilized the ACE tools (internal SOP) and designed production layout using TPM (preventative maintenance) and 6S guidelines.

Used lean manufacturing tools to perform statistical process control and PFMEA for process operations

UConn Health Center:

Undergraduate Research Assistant, August 2008-May 2010

Farmington, Connecticut

Created tissue engineered scaffolds using induced pluripotent stem cells

Monitored bench top bio-reactors for cultivating osteoblasts and bone morphogenic proteins(BMP)

Designed batches of simulating body fluid (SBF) to improve the biocompatibility of scaffolds to osteoblasts.

Adhered to GLP during animal testing of tissue engineered scaffolds in-vivo, while performing confirmation runs with microfluidic devices

Pfizer:

Clinical Programming Intern May 2008-August 2008

New York City, New York

Reviewed clinical trial case study reports for Chantex and Lipitor,

Cross referenced indications for each drug with actual findings in each report and calculated accuracy percentage

Participated in general intern group projects, such as FDA regulation requirements and mock clinical trial reviews for potential drug candidates.

University of Connecticut:

Undergraduate Research Assistant, August 2007-May 2008

Storrs, Connecticut

Monitored small scale distillation columns for methanol recovery

Design an energy efficient separation system using a cold trap

Led the scale up for purification of crude glycerol as a recycle feed for bio-butanol fermentation

Assisted PHD candidate with plug flow reactor design for biodiesel production.

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