Analytical Chemist Job: Masachusetts

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Analytical Chemist Job: Masachusetts

Aerotek is looking for an Analytical Chemist to work with one of our clients in the Billerica, MA area.

Brief job description and requirements:

Performing QC assays
Assisting in validation of QC assays
Compile, analyze and document chromatographic data.
Perform routine/non-routine data analysis calculations.
Document analytical data under cGMP and corporate guidelines.
Participate and resolve laboratory investigations of unexpected analytical results
Writing and establishing specifications
Support cGMP laboratory initiatives following laboratory SOPs.
Writing laboratory SOPs
Operation, maintenance and calibration of HPLC and GC equipment
A degree in chemistry, biochemistry or related scientific discipline.
Experience in HPLC and/or GC instrumentation
Atlas system software experience a plus

Required Skills:
HPLC, QC ASSAYS, SOP GMP, GC

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.

Contact Information

Contact: Lisandra Colon Diaz
Email: eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%6c%63%6f%6c%6f%6e%40%61%65%72%6f%74%65%6b%2e%63%6f%6d%22%3e%6c%63%6f%6c%6f%6e%40%61%65%72%6f%74%65%6b%2e%63%6f%6d%3c%2f%61%3e%27%29%3b'))
Address: 101 Grovers Mill Road, Suite 103
Lawrenceville,NJ 08648
Phone: (609) 378-4003
Fax: (609) 378-4030

abdulkalim
abdulkalim's picture
CURRICULUM VITAE

CURRICULUM VITAE
 

Abdul Kaleem

 

 

H. No: 3-16-96/2, Venkat Reddy Nagar, Ramanthapur, Hyderabad-500013, Andhra Pradesh, India.

Mobile: 00966-542306121
abdulkalim2001@yahoo.co.in
abdulkalim@rediffmail.com

 

Career Summary

 

 

 

 

Result oriented, qualified professional with extensive experience of over 8 years in Pharmaceutical industry, currently operating as an Assistant Manager in Jamjoom Pharmaceuticals-Jeddah (KSA) (Generics). Solid administrative and analytical experience includes expertise at quality control of finished products and standard operating procedures with adept knowledge in pharmaceutical operations. Finished product analysis by Liquid Chromatography, Gas Chromatography, UV-Spectrophotometer, IR DSC, UPLC and Dissolution. Successfully faced WHO, MHRA, MCC-South Africa, USFDA, HPFB-Canada, TGA, GHA and EDQM for COS auditand its compliance. Copiously experienced in monitoring and ensuring that GLP is followed in the laboratory. Adroit in managing review and approval of SOPs, Specifications, STPs, GTPs, Validation and Stability Protocols. Well versed with trouble shooting of analytical instruments. Excellent team player, possess skills of operations management, people and man management.

 

 

Career Objective

 

 

 

 

I aspire to look forward for a position of Group Leader/Executive Instrumentation Analyst Pharmaceutical/Biotechnology Industry, where I can utilize my skills and experience to an optimum level thereby providing organizational as well as my professional growth. I propose myself with:
 
v Expertise at Raw materials and finished product analysis, Process validation & Process development, SOP preparation, Cleaning Validation, Method Transfer, Hold time Study Calibration and Documentation.
v Conversant with Standard Operating Procedures (SOP’s) Preparation and Guidelines.
v Adept in handling HPLC, DSC, Gas Chromatography, UV-Spectrophotometer, IR-Spectrophotometer and TOC. 
v Equipped with the aptitudes of leadership qualities, and trouble shooting skills.
v Result oriented persona with the aptitudes of excellent interpersonal and communication.

 

 

Professional Accomplishments

 

 

 

 

v Awarded Excellent Contributor for the year 2007 at Dr.Reddy’s Laboratories Limited (Generics-Unit-III).
v Our team succeeded in Maximum releases of ARV products in WHO market at Aurobindo Pharma Limited.

 

 

Professional Experience

 

 

 

Executive Instrumentation Analyst
Jamjoom Pharmaceuticals (Generics-Unit-III),Jeddah-KSA.

January 2009- To Date

v       Preparation/Review of Standard Operating Procedure, Standard Test Procedure and Specifications.
v       Preparation of Calibration/Performance Verification/Preventive Maintenance Master Plan, Monthly plan and Annual Preventive Maintenance Plan.
v       Instrumental/Wet Analysis of Finished Products and Raw Materials.
v       Analysis of Process Validation Samples.
v       Qualification of Laboratory Instruments/Equipments (IQ, OQ, PQ).
v       Looking after timely Calibration/Performance Verification of all Laboratory Instruments/Equipments.
 
 

 

Junior  Manager
Dr.Reddy’s Laboratories Limited, (Generics-Unit-III), Hyderabad.

April 2006- To January-2009

 

 

 

v Responsible for analysis of products, for regulatory submission of solid oral dosage forms (Tablets and Capsules) to regulated markets.
v Involved in preparation & review of protocols, record of results & reports for method development & method validation.
v Manage review and approval of SOPs, Specifications, STPs, GTPs, Validation and Stability Protocols.
v Handling discriminatory dissolution profiles studies and dissolution profiles with Innovator Products.
v Maintaining Qualification (IQ, OQ, PQ) of analytical instruments/equipments.
v Monitoring and ensuring that GLP is followed in the Laboratory.
v Ensure training and qualification of the analysts.
v Reviewing weekly and monthly reports, analytical records and Stability data trends and timely submission to RA for further submissions.
v Ensuring that required reference standards, chemicals, columns, working standards, stock cultures etc are available.
v Review of ensure availability of resource requirement for new product tech transfer and product execution.
v Ensuring stability studies are carried out as per the schedule.
v Reviewing and releasing   indents related to QC operations and budget monitoring.
 

 

Senior Executive
Aurobindo Pharma Limited, Hyderabad

July 2003- March 2006

 

 

 

v Responsible for the all activities in quality control lab.
v Managing process validation, hold time study analysis, method transfer, and process development analysis.
v Responsible for validation of process development and process validation samples.
v Performing dissolution profile comparison studies for submission batches.

 

 

 

Quality Control Officer
Granules India Limited, Hyderabad

April 2001- June 2003

 

 

 

v Involved in analysis of finished product process development, exhibit and hold time study sample analysis.
v Responsible for finished product analysis, in-process analysis, method transfer and hold studies.
v Manage process validation and cleaning validation
v Performing raw material, finished product and bulk samples analysis.
v Generating and updating SOP’s.
v Involved in validation and calibrations of lab equipment.
v Maintaining control samples analysis [Stability samples].

Areas Of Expertise

 

 

 

 

 

Raw Material & Finished Product Analysis (Instrumental and chemical Analysis):

v Finished Product Analysis by Liquid Chromatography, Gas Chromatography, UV-Spectrophotometer, IR DSC, UPLC and Dissolution.
v Raw Material Analysis, Preparation of Working Standard, Preparation and Standardization of Volumetric Solution.

 

 

 

Process Validation and Process Development

v Analysis of Process Validation samples(In-Process)atdifferent stages of manufacturing.
v Process development by performing analysis comparatively with Innovator samples i.e. Dissolution Profiles.
v BIO Batch on time analysis for submitting to Regulatory Bodies
v Cleaning Validation, Method validation, and Hold time studies

 

 

 

SOP preparation

v Preparation and updating of Analytical Lab SOPs

 

 

 

Calibration

v Calibration, performance check of instruments / Equipment of Quality Control. Viz. HPLC, Gas Chromatography, IR, UV and dissolution

 

 

 

Documentation

v cGMP, GLP based working Method
v Record updating and On-Line documentation
v Data analysis as per regulatory requirements
v Technical support to QA, Validation, stability and FR&D

 

 

 

Instruments Handle
 

v HPLC (Waters, Agilent, Shimadzu, Perkin Elmer] [with EMPOWER Software]
v Ultra Performance Liquid Chromatography
v DSC
v Gas Chromatography [Waters, Agilent, Perkin Elmer]
v UV-Spectrophotometer
v IR-Spectrophotometer
v TOC.
v Dissolution (12 Stations), Dissolution Apparatus-III, Dissolution Type-4

 

 

 

Audits Faced

v WHO, MHRA, MCC-South Africa, USFDA, HPFB-Canada, TGA, GHA and EDQM for COS audit and its compliance.
 

 

 

Education

 

 

 

 

Master of Science (Chemistry)
Madurai Kamaraj University, Tamilnadu, India.

 

 

 

Bachelor Of Science (Chemistry)
Osmania University,

 

 

Technical Skills

 

 

 

 

Software/Tools
 
LIMS operations
MS Office
Lotus Notes

Proficiency
 
Proficient  
Proficient
Proficient

 

 

Trainings Attended

 

 

 

 

Training of Waters HPLC

 

Attend Training on GLP Seminars

 

Training on Agilent GC and HPLC.

 

 

Personal Details

 

 

 

 

Date Of Birth

1st January 1979

 

Father Name

Md.Nazeeruddin

 

Marital Status

Married

 

Languages Known

English, Hindi, Urdu &Telugu

 

Nationality

Indian

 

Passport Details

B5208787       

 

Personal Interests

Reading Books, Playing Chess, Painting, Cooking.

 

 

 

Reference

 

 

 

 

 

 

1.   G.T Damodar – (Deputy Manager –Analytical Development)    
      Natco Pharma Ltd-Hyderabad                                                                                      
      Cell .No: +919849892957

 

2.   Shaik Mohammad Noor (Deputy Manager-Quality Control)
      Actavis Pharma Limited-Chennai.
      Cell. No: +919952035363

 
 
 
 
 
 
 
 
 
 
 

 
I hereby declare all the above given information is true to best of my knowledge and belief.
 
 
Station            : Jeddah (KSA)                                                
 
Date                : 
 
(MD.ABDUL KALEEM)