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GMP Laboratory Professional

Location:
North Andover, Massachusetts, 01845, United States
Salary:
60000
Posted:
January 10, 2018

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Thomas E. Kelley

* ******* ***** #*** 978-***-****

North Andover, MA 01845 ac3zdw@r.postjobfree.com

January 2017-Present PerkinElmer Inc. (Billerica, MA)

Associate Process Chemist

Perform chemical assays to support Yttrium-90 production for use as an Active Pharmaceutical Ingredient (API) in chemotherapeutic applications, including Thin Layer Chromatography (TLC), Inductively Coupled Plasma (ICP-OES) emission spectroscopy for the detection of trace metal impurities and Gas Flow Proportional Counting for determination of radionuclidic ratios

Complete process and equipment qualifications and validations to support ongoing manufacturing processes

Conduct internal audits and effectiveness checks across multiple departments and sites to support ISO9001:2015 standards

Act as group document coordinator of a GMP product line to maintain compliance with quality and radiation safety guidelines, including ICH-Q7 and 21CFR210/211

April 2013-December 2016 PerkinElmer Inc. (Boston, MA)

Lead Manufacturing Technician

Act as technology transfer lead for two microfluidic product lines, LabChip XT and LabChip GX, from California to Boston and establish manufacturing capabilities to meet rigorous production deadlines, including establishing a class 10,000 clean room environment for the formulation and dispensing of FDA regulated products

Lead associate technicians in the production and testing of the RNA/DNA analytical microfluidic electrophoresis products using an automated dispensing system in a clean room setting

Responsible for coordinating the industrial scale dispensing and packaging of bulk reagents for the creation of 10,000 kits annually in accordance with Lean manufacturing principles

Act as certified ISO9001:2008 internal auditor as well as group document coordinator responsible for group quality assurance

Assist with CAPA/FMEA process to assess risk and handle customer complaints

Coordinate special projects with Quality and EHS personnel to generate material safety data sheets in compliance with international trade regulations

Initiate cost savings and workflow improvements to reduce labor and scrap as well as enhance automation within the process

Responsible for procuring non-inventory and Kanban consumables as well as sourcing materials and qualifying vendors

Maintain production schedule, inventory, and controlled documents using SAP software, and act as Codesoft (SQL) site administrator

February 2010-January 2013 SpringLeaf Therapeutics (Boston, MA)

Lead Manufacturing Technician

Developed electro-mechanical assembly and materials processing techniques from experimental phase to FDA-regulated processes, including clean room policies to meet ISO13485 and CFR820 standards, compliance training, and manufacturing protocols and batch records

Provided support for the development and implementation of validation procedures (IQ/OQ/PQ) to gain CE Mark certification

Manufactured components of a proprietary electrochemical cell for use as an actuator in a patch-pump device in a clean room setting, including soldering and computer-aided testing with Maccor and VMP3 instruments, discharge circuits, Keyence sensors and flow-cell spectroscopy

Scaled-up manufacturing process from research phase experiments into commercial level production line capable of producing 30k units annually

Performed the role of group leader to assist in the hiring and training of technicians and to oversee their work with regard to standards of quality and documentation

Ensured that protocols and procedures were executed by lab staff to specification and that manufacturing goals were met in a timely manner

Developed a variety of analytical techniques for the purpose of maintaining quality acceptance criteria of manufactured products, including total protein assays of experimental pharmaceuticals and electrochemical analysis of the device and qualification of vendors and materials

Established quality control standards as part of a larger quality management system matrix which included inspection methods for received materials and finished goods, qualitative analysis, equipment validation and manufacturing SOPs

Performed the role of document coordinator, including organizing MSDS sheets, sourcing materials and comparing vendors, and assembling guidelines based on data analysis

September 2008-February 2010 Protein Forest, Inc. (Lexington, MA)

Manufacturing Associate

Responsible for manufacturing and kitting of acrylamide-based electrophoresis products through the use of a robotic dispenser,

Maintained inventory and distribution of reagent consumables by manufacturing buffers, stains, and detergents and chips

Developed more efficient production methods through experimentation with a variety of polymerization initiators and conditions, including surface coatings and plasma treatments

Coordinated with marketing and sales personnel to create new product lines of Western Blot consumables

Worked closely with engineers to develop more effective methods and processes for Lean manufacturing and product development

Authored protocols for work in a GMP-compliant Class 10,000 clean room to produce reagent consumables for a commercial product line

August 2007-April 2008 Chemgenes Corporation (Wilmington, MA)

Oligomer Production Chemist

Performed complete production of custom RNA/DNA oligomers for commercial sale, from customer order through shipping

Purified RNA/DNA products as well as phosphoramidites by column chromatography using Sephadex, silica and resin columns and cartridges

Performed quality control analysis and quantification of RNA/DNA products through Beckman Coulter capillary electrophoresis, UV spectroscopy and thin-layer chromatography

Designed purification techniques and authored technical data sheets for specially modified oligomers

May 1997-January 2000 Massachusetts General Hospital

Research Laboratory Technician

Genomic research of patients affected by young-onset Torsion Dystonia and Parkinson’s Disease through polymorphism analysis and Sanger sequencing

PCR for primer-mediated amplification, DNA sequencing via P32/33-labeled autoradiograph and LiCor infrared dye, SSCP through silver staining, agarose/acrylamide gel electrophoresis

Education

Boston University Bachelor of Science cum laude -- Biology

Certificate in Biotechnology

Worcester State University Master of Science -- Biotechnology

(to be completed 5/2019)



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