Manufacturing Technician

Bishawjit Saha

*** ********* ******, *****, **, *1720

**********@***.***, 617-***-**** h, 617-***-**** c

Objective: To obtain a Manufacturing Associate position applying my

scientific background and lab automation skill

Instrument / Lab Skills and Expertise:

cGMP and SOP documentation

Proven track record of performance

Attention to detail

Meticulous record keeping

Team collaborator

Organizational and planning skills

MS Word/Excel/MS PowerPoint

Outlook

Database

Languages: English, Bengali

Aseptic Technique

Automated Liquid Handling

Bacteria Transformation

Bradford Protein Assay

Buffer Preparation

Cell Culture

Centrifugation

cGMP Training Certificate

Data Presentation

DNA Fingerprinting

Documentation

Electrophoresis

ELISA

Gel filtration

Chromatography

Hemacytometer

Media Preparation

Microscopy

Serial Dilutions

Spectrophotometer

LIMS System

Work Experience:

Allergan

Senior Manufacturing Technician

August,2014-Present

RESPONSIBILITIES:

Execution of manufacturing activities, such as monitoring equipment and

recording data, including documentation as required by QSR

Ensure the adherence to procedures, including the review of manufacturing

documentation from a "hands on" perspective to ensure practical

feasibility.

Setup and setup verification of all process equipment.

Ensure all appropriate training is completed prior to production campaigns.

Ensure all equipment is cleaned and ready for scheduled and unscheduled

production campaigns.

Perform process adjustments according to EOP or MOP

Lantheus Medical Imaging,

N.Billerica, MA

Quality Analyst, Physical Testing

Sept, 2012-August 2014

. Perform paperwork review of laboratory data to ensure accuracy.

. Perform calibration and maintenance on laboratory instruments.

. Initiate SOP changes, provide review and coordinate changes in the

documentation system.

. Provide problem solving skills to support the resolution and

documentation of investigation for laboratory and manufacturing issues.

. Maintain and increase personal scientific, regulatory and compendia

expertise and work with lab

Management to develop organizational capabilities.

. Stay current with various regulatory requirements and procedures.

. Working knowledge cGMP, USP, FDA and ICH guidelines.

. Execute protocols for procedural and instrumentation validations.

. Conduct QC testing for raw materials, buffers and solutions, controls,

formulated reagents, and final

. Reagent kits to ensure compliance to quality standards.

. Support technology-transfer for all analytical methods to pilot plant and

manufacturing operations (QC) for QC release testing.

. Technical expertise in conducting analytical testing using PCR, RT-PCR,

HPLC, CE, fluorescence and/or absorbance spectrophotometers

Genzyme Biosurgery, A division of Sanofi Corporation Cambridge, MA

Manufacturing Technician Senior Jan.2012 - Sept.2012

. Assist in production of Chondrocytes in a class 10,000 cleanroom

. Perform aseptic manipulations of cell cultures, final product assemblies

and support functions

. Adhere to cGMP regulations/guidance and company Standard Operating

Procedures (SOPS)

. Commented and reviewed SOPs by providing subject matter expertise input

to the technical content

Manufacturing areas may include Cell Culture, Harvest, Media,

Purification,

. Buffer Prep, Dispensing and Drug Product filling, labeling and

packaging.

. Hands on operations including set-up, pressure test (PT) and

operation of

. production equipment.

. perform and/or monitor critical processes, execute validation

. protocols, and perform equipment troubleshooting along with the

ability to

. recognize and accurately report problems.

. draft and revise documents such as Manufacturing Procedures and

. SOPs. Execute SOP

. Assist in the review of documentation for assigned functions

(e.g. equipment

. logs, routine area audits, batch records)

Rain Dance Technology Lexington, MA

Manufacturing Lab Technician Oct.2011- Jan.2012

. Able to work in a cGMP environment using SOPs to produce high quality,

highly reproducible results

. Demonstrated ability to work in an interdisciplinary team setting

. Processed samples using Rain Dance Technologies Sequence Enrichment

application

. Prepared samples to go into instrument

. Performed data entry of information into database Excel, Access.

. Performed Sample Purification, Normalization, QC testing, Analysis.

. High attention to experimental details and meticulous record keeping

AstraZeneca Waltham, MA

Research Associate, Compound Management Oct.2008- Oct.2011

. Prepared chemical compounds for scientists' use in Cancer and Infection

research

. Received chemical samples, weighed, dissolved, reformatted, plated,

dried, organized and stored samples

. Entered all new compound orders, weighed solids to create solutions using

a Tecan liquid handler

. Processed dry and liquid samples, manually and using automated and plate

handling equipment

. Reviewed and approved GMP Controlled Documents, including SOPs, Batch

Records, and Test Methods

Volunteer Experience

Cambridge Public Schools Cambridge, MA

Volunteer Teacher: biology, chemistry and math

1996-Present

Education

Boston College, William F. Connell School of Nursing Boston, MA

Clinical Research Certificate 2009

Boston University School of Medicine, City Lab Academy Boston, MA

Biomedical Laboratory Science Certificate 2008 - 2009

Chittagong University Chittagong, Bangladesh

Bachelors of Science, Education major 1992

Chittagong University Chittagong, Bangladesh

Bachelors of Science, Science major 1989

Course

Introduction to Biomedical Laboratory Science (with lab) Boston University

Medical Terminology Boston University

Cell Culture Techniques (with lab) Boston University

Biotechnology Patient Samples Boston University

Essentials of Initiating Clinical Research Boston College

Health Care Statistics Boston College

Clinical Research Internships Boston College

Special Recognition

Talent of the Month nomination Waltham, MA

AstraZeneca Compound Management Team June

2011

For outstanding performance of handling high volumes for entire site in a

short turnaround time

General Secretary of the Teacher's Association Chittagong District,

Bangladesh

General Secretary of Boy Scouts of Bangladesh Bangladesh

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