HACHIK CHILINGIRIAN

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

781-***-**** (home), 781-***-**** (cell) actiyw@r.postjobfree.com

WORK EXPERIENCE

GENZYME CORPORATION

CELL CULTURE MANUFACTURING PLANT Framingham, MA

Manufacturing Associate

2013 – Present

Performs 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.

Utilizes process control Delta V system, LIMS, aseptic practices, Osmometers, BGA, pH and conductivity meters. Performs titrations. Completes electronic batch records in a Manufacturing Execution System (MES). Reviews batch records. Documents deviations (TrackWise). Updates SOPs (DCR).

Performs a shift leading role as needed: makes work projects assignments, ensures the production schedule attainment, troubleshoots process and equipment issues, prepares and conducts shift changes.

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

Assist Engineering and QA in validation and investigation studies (PQ, RQ, ETPs).

LIFE TECHNOLOGIES CORPORATION

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 continuously 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 BIOSYSTEMS/ LIFE TECHNOLOGIES CORPORATION

LARGE SCALE CHROMATOGRAPHIC MEDIA MANUFACTURING PLANT Bedford, MA

Manufacturing Supervisor 2005 - 2010

Managed ten technicians (five direct reports) and two shifts plant batch process operations for manufacture of chromatographic media (suspension polymerization) in an ISO 9001:2008 certified facility – revenues $35 million.

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.

APPLIED BIOSYSTEMS

LARGE SCALE CHROMATOGRAPHIC MEDIA MANUFACTURING PLANT Bedford, MA

Lead Manufacturing Technician 1999 – 2005

Managed ten technicians and two shifts plant batch process operations (Delta V).

Prepared weekly and daily production schedules and reports for both shifts.

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

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

PERSEPTIVE BIOSYSTEMS

PILOT SCALE CHROMATOGRAPHIC MEDIA MANUFACTURING PLANT Cambridge, MA

Senior Manufacturing Technician 1994 – 1999

Prepared daily schedules for two shifts and assigned work projects.

Operated reactors, pressure filters, screens, dryers, air classifiers, elutriation cones, viscometers, FTIR spectrometers, moisture analyzers. Conducted suspension and solution 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

Developing Team Process for Continuous Improvement

Advanced Problem Solving and Root Cause Analysis

Basic Statistical Process Control Workshop

Introduction to Design of Experiments

Failure Mode and Effects Analysis Workshop

Implementing the Five S + 1 System

LANGUAGES/ INTERESTS

Fluent in English, Armenian, Bulgarian and Russian

Long distance running, soccer, skiing, wood carving, theater

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