Quality Control Medical Devices

HACHIK CHILINGIRIAN

*** ***** ******, **********, ** 01890 U.S. Citizen

781-***-**** (cell) 781-***-**** (home) *********@*******.***

WORK EXPERIENCE

LYRA THERAPEUTICS Watertown, MA

Senior Technician Nov 2023 – May 2024

Manufacturing novel extended-release drug delivery systems in clean room environment. Chemical solutions preparation, fixtures setup, spray coating, heating and drying, manual trimming and welding of braid and base drug delivery structures, microscope visual inspections.

Setup and operated manufacturing equipment. Executed R&D experiments and process development projects.

Performed routine WIP testing to produce data for process quality control or the support of process and product developments.

Trained newly hired technicians and oversaw their work.

Assisted in performing required process capabilities studies, equipment installation/operational qualifications, process validation, and analysis of test data.

Worked alongside the engineering and QA/QC departments to troubleshoot and solve production related issues.

Assisted in QA department audits of in-process manufacturing documentation in production areas.

LYNDRA THERAPEUTICS Lexington, MA

Manufacturing Lead Feb 2022 – Sep 2023

Manufacturing novel extended-release drug delivery systems in clean room environment. Polymer drying, blending, extrusion and spray coating. Automated and manual assembly of polymer based dosage forms by plastic laser welding techniques. Powder blend granulation and capsule coating. Execution of R&D experiments and process development projects.

Authored and updated SOPs. Assisted with the continuous improvement of production processes, documentation and equipment. Trained newly hired technicians and oversaw their work.

GCP APPLIED TECHNOLOGIES, VERIFI Plant Cambridge, MA

Manufacturing Supervisor Nov 2019 – Dec 2021

Senior Manufacturing Technician April 2016 – Nov 2019

Assigns daily work projects to technicians. Participates in the hiring and performance review process, trains and cross-trains. Troubleshoots process and quality issues, plans and completes corrective and preventive actions. Oversees work and ensures production objectives are achieved.

Maintains man power utilization and productivity analysis data of the plant manufacturing operations.

Authors and updates SOPs. Assists with the continuous improvement of production processes, documentation and equipment. Participated in the implementation of weight quality control system of kits and Verbal Pick Line Kitting system that increased productivity more than 200% and reduced quality deviations.

Set up an upgraded warehouse of more than 800 part numbers. Created lists of parts and assemblies with their images and storage locations to improve warehouse operations and reduce inventory discrepancies.

Receives deliveries of parts and materials in the warehouse and maintains inventory control. Completes production supplies shipments for product systems installation and parts restocking.

Completes the SAP (ERP) transactions for received goods and completed assemblies, kits and shipments .

Assembles electro-mechanical fluid delivery systems and subsystems per work procedures and drawings. Performs quality control through final functional testing of subsystems and finished products.

GENZYME CORPORATION, Cell Culture Manufacturing Plant Framingham, MA

Manufacturing Associate 2013 – April 2016

Performed media preparation in Upstream Cell Culture plant batch operations (cleanroom) in compliance with cGMP, FDA and Quality System regulations, SOPs, GDP, safety and 5S guidelines.

Conducts PM, CIP and SIP operations of equipment preparation for media batch processing.

Utilized process control Delta V system, LIMS, aseptic practices, Osmometers, BGA, pH and conductivity meters. Performed titrations. Completed electronic batch records in a Manufacturing Execution System (MES). Reviewed batch records. Documents deviations (TrackWise). Updated SOPs (DCR).

Performed a shift leading role as needed: made work projects assignments, ensured the production schedule attainment, troubleshooted process and equipment issues, prepared and conducted shift changes.

Trained and directed the new and less-experienced manufacturing personnel (SME, “trained trainer”).

Assisted Engineering and QA in validation and investigation studies.

LIFE TECHNOLOGIES CORP. Performance Optimized Polymer (POP) Manufacturing Plant Framingham, MA

Manufacturing Supervisor 2010 – 2012

Managed eleven direct reports and two shifts plant batch process operations for manufacture of polymers (solution polymerization, ultrafiltration) and buffer solutions for DNA sequencing instruments in a ISO 9001:2008 certified facility. Implemented the concept of a High Performance Work Team.

Oversaw Bulk Manufacturing, and Reagents Filling and Packaging (cleanroom) Operations with annual revenues of $70 million.

Prepared plant weekly production schedules in SAP and ensured their attainment in compliance with Quality System regulations, SOPs, GDP, safety guidelines, ISO, cGMP and 5S.

Managed hiring, training, performance management and career development of direct reports.

Authored and updated SOPs, UOPs and other production documentation to reflect current processes

and best practices. Ensured processes are continuously improved (value stream mapping, SPC).

Reviewed batch records. Ensured all process and quality deviations are reported (TrackWise). Maintained statistical charts (MINITAB) to identify ‘special cause’ variance of in process quality control failure rates and final yields. Collaborated with Maintenance, Facilities, Process Engineering, Quality Control (QC) and Quality Assurance (QA) to investigate (DMAIC) root causes of deviations, plan and implement CAPAs.

Led cross functional teams of continuous improvement projects. Led Lean and Six-Sigma initiatives to improve cost, quality and lead-times.

Collaborated with Planning group and Product Management to review market forecasts and plan plant capacity –personnel and equipment.

Applied lean principles (6 Sigma, 6S, value stream mapping and statistical process analysis).

PERSEPTIVE BIOSYSTEMS/ APPLIED BIOSYSTEMS/ LIFE TECHNOLOGIES CORP. (name changed by M & A)

Large Scale Chromatographic Media (POROS) Manufacturing Plant (1999 – 2010) Bedford, MA

Pilot Scale Chromatographic Media (POROS) Manufacturing Plant (1994 – 1999) Cambridge, MA

Manufacturing Supervisor 2005 – 2010

Lead Manufacturing Technician 1999 – 2005

Senior Manufacturing Technician 1994 – 1999

Managed ten technicians and two shifts plant batch process operations (Delta V) for manufacture of chromatographic media (suspension polymerization) in an ISO 9001:2008 certified facility.

Prepared weekly and daily production schedules and reports for both shifts. Assign work projects.

Analyzed plant process data, maintained batch records, authored SOPs and UOPs.

Maintained equipment utilization database to determine required capacity changes.

Participated in plant transfer and start up, and equipment and process validation studies (IQ/OQ/PQ). Worked on process engineering projects, bench scale experiments, process transfers, and scale up.

Collaborated with Engineering department for the resolution of process and equipment issues.

Operated reactors, pressure filters, screens, dryers, air classifiers, elutriation cones, viscometers, FTIR spectrometers, moisture analyzers. Conducted suspension polymerizations and various chromatographic media coating processes.

CHEMDESIGN CORPORATION Fitchburg, MA

Quality Control Lab Technician/ Chemical Operator 1992 – 1994

Performed chemical analysis, using HPLC, GC, IR and wet chemical methods.

Conducted plant batch process operations for custom manufacture of specialty chemicals.

EDUCATION

Bachelor of Science in Chemical Engineering, Major: Polymers

Institute of Chemical Technology ”Prof. Dr. Asen Zlatarov” - Burgas, Bulgaria

Additional Relevant Coursework (based in the U.S.):

Understanding and Implementing Lean Manufacturing

Six Sigma Process Improvement - Tools and Concepts

Advanced Problem Solving and Root Cause Analysis

Basic Statistical Process Control Workshop

Implementing the Five S + 1 System

LANGUAGES: English, Armenian, Bulgarian and Russian

INTERESTS

Long distance running, soccer, skiing, wood carving, theater, poetry, filmmaking, drawing/painting

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