Christopher A. Hussey

** ****** ** ***** * Worcester, MA 01607 • ad0ae2@r.postjobfree.com • 508-***-****

Education

WESTFIELD STATE UNIVERSITY Westfield, MA

Bachelor’s Degree in Cellular and Molecular Biology May 2012

Minor in Chemistry

Well-rounded in laboratory sciences including Microbiology, Organic, General/ Analytical Chemistry and Genetics

MASS BAY COMMUNITY COLLEGE OF HEALTH AND SCIENCES Framingham, MA

Massachusetts and National EMT Certification December 2012

Experience

Waters Technologies Milford, MA

Quality Software Testing Engineer II (Team Lead) June 2019-March 2023

●Unit and integration testing of System Software (Empower).

●Focused on software and system product quality, safety, design, and reliability for production builds of software released to the market. Following WSDP and remaining compliant with Quality Assurance, FDA, and participating in customer Audits,

●Computer System Validation/cGMP, setting up brand new UPLC, HPLC, GC systems and instruments.

Validating the IQ/OQ/PQ of various systems when equipment is serviced and or equipment replacement etc.. All while complying with 21 CFR 211.68 and 211.160 GAMP among other protocols always FDA Audit ready and compliant.

●Worked independently and collaboratively with software development engineers and chemists in the lab to define test strategies, write and execute test script case scenarios and build automated test routines and validation of systems and Empower software.

●Actively participated in the software development lifecycle through review of requirements, risk management and maintaining traceability in an agile software development environment.

Hill-Rom Acton, MA

Quality Assurance Engineer March 2019-June 2019

●Tasks include but are not limited to redlining, obsoleting and updating Standard Operating Procedures to sync with the newly implemented SAP system.

●Worked with various teams and departments determining specific process flows and procedures to update governing SOP’s. Increasing efficiency and focusing on compliance through GMP and GDP.

●Worked with Quality Assurance and Regulatory departments on validating new systems and equipment for SAP process implementation.

●Defect Tracking and Control, Investigating CAPA’ In accordance with FDA regulations and Companies SOP Policies.

EyePoint Pharmaceuticals Watertown, MA

GMP Quality Control Dept. (Lead Analytical Chemist) November 2017-March 2019

●As the lead Quality Analytical Chemist I collaborated with ophthalmology and oncology teams through EyePoint’s formerly (psividas) clinical trials of Iluvien™, which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME

● Managed a team responsible for analytical quality control testing of Eyepoint’s formerly (psivida) FASRI insert (Fluocinolone Acetonide), Dexamethasone eye device products, following S.O.P.’s in accordance with FDA regulated GxP (GMP, GLP, GDP, best practices)

●Reviewed and approved all QC testing data for release in accordance with company’s procedures and applicable GMP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines, etc.).

●HPLC testing API raw material, finished goods, in process, release rate testing, related substance and compound determination, Finals product and release batches.

●Managed and responsible for overall GMP QC laboratory to ensure necessary tasks are performed by QC staff.

●Reviewed all QC testing data, scheduled and coordinated outsource testing, stability/sterility testing, EM, water testing, laboratory equipment calibration scheduling etc.

●Worked and interacted with cross-functional colleagues from Development, Operations, QA/QC, and Regulatory Affairs departments through an NDA and contributed to taking EyePoint Pharmaceuticals public.

●Provided supportive role in NDA filings including clinical trial materials/commercial materials, DCO’s, CAPA’s, OOS, OOT, commercialization processes, audits and successfully launched YUTIQ commercially

SANOFI/GENZYME Allston, MA

Quality Control Analyst II (Microbiology) December 2016-November 2017

●Analyzed assay data for Sanofi’s bio-therapeutic Cerezyme product including raw material testing.

●Collaborated with QA, Validation and Engineering teams to qualitatively and quantitatively report data ensuring results are within specification and are USP and FDA compliant.

●Aided in generating data trend reports and validation studies while upholding the highest level of data integrity.

●Worked independently and cooperatively as a team to support manufacturing activities by detecting, identifying and addressing possible contaminants in the pharmaceutical manufacturing process.

●Performed assays including but not limited to Bioburden, Endotoxin, plate reading, Bradford protein, and Biological indicators in accordance with SOP’s and CGMP regulations.

●Participated in training, writing and revising SOP’s, entering and reviewing data in LIMS, performed safety and operational audits, assisted in deviations and root causes with QA and Investigation departments

●Environmental Monitoring with Climet particle counters, SAS viable air samplers, RODAC surface sampling,

●Cerezyme formulation EM monitoring, Validation EM testing release, Action notice system and room release environmental monitoring. Class C and D routine and non- routine EM in restricted areas of manufacturing and various labs and BSC’s.

●Environmental Monitoring and testing for Water/Steam/Gas and Critical utility systems, WFI, RO, Milli-Q and lab water sites throughout the entire facility.

ZEPTOMETRIX CORPORATION Franklin, MA

Quality Control Testing Technician January, 2015-December 2016

●Analytical quality testing of raw materials, UV, VIS spectroscopy.

●Working collaboratively with QA, RA management, manufacturing, molecular diagnostic division and research departments to meet deadlines. Ensuring that data meets USP and FDA specifications prior to release on the market and used with patients.

●Duties include but not limited to performing preprocessing and final release testing on FDA regulated biological diagnostic controls, following all applicable manufacturing regulations and practices, and in accordance with SOPs.

●Performed a variety of testing including DNA and RNA extractions, qPCR, ELISAs, rapid testing, HPLC/ Chromatography, VITROS ECiQ, Quidel Sofia, Cepheid GeneExert, BioFire FilmArray.

● Worked with QA and Document Control and Regulatory department in writing and reviewing SOPs, assisted in CAPAs, deviations, (IQ, OQ, PQ) lab equipment set up and validation.

Leadership and Activities

UNIVERSITY OF MASSACHUSETTS AMHERST RESEARCH CONFERENCE Amherst, MA Independent Laboratory Research

●Participated in an independent laboratory research conference focusing on PCR DNA analysis.

●Volunteered at Thundermist Medical Center as a laboratory medical assistant performing diagnostic tests.

●Tutored Students in both Chemistry and Biology at Westfield State University.

Skills/Experience and Interests

Technical: Great attention to detail, Medical Terminology, EMR software, Office, SPSS, LIMS, AGILE, GIT, Atlassian Tools, ASTME2500, ISO, GxP, ICH Standards, Validation, Stability Testing and design of Eye pharmaceutical drug inserts.

Laboratory: HPLC Waters Systems (Empower Trained), Microscopy, Spectroscopy, Chromatography, NMR, Electrophoresis, Aseptic Technique, Environmental Monitoring, Bioburden, Endotoxin testing

●Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment

●Working knowledge of GMP documentation and application of principles, theories and practices of the analytical chemistry and/or microbiological

●Flexible and able to respond quickly to shifting priorities and meet deadlines.

●Strong verbal and written skills

Interests: Include but are not limited to Chess, Golf, Ice Hockey, Skiing, Hiking, Camping, Dirt Biking, Repairing & Rebuilding vehicles and many others.

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