Development Quality Control

TAZIN MAHNAJ

** ****** ****, *******, ** *****

Contacts: 845-***-****

*******@***.***

SUMMARY

R&D scientist experienced in method development and validation in the pharmaceutical

industry. Provides support to the group in developing and validating analytical methods

based on scientific knowledge and experience, ensuring that all critical parameters are

included in executing method validation activities. Expertise in solving problems,

developing value-added techniques for raw materials, finished products and innovative

products to support the formulation and product development group. Writes protocols

and specifications based on USP, ICH or other compendial or regulatory requirements.

Write analytical reports using correct language and terminology. S trong instrumental

skills, Participate in instrument troubleshooting and conducting Out-of-Specification

(“OOS”) investigations, in accordance with current regulatory guidelines and laws. Self

motivated and worked independently in multiple projects in fast paced team

environment.

TECHNICAL SKILLS/ KNOWLEDGE

Extensive knowledge and hands-on experience to run samples following the analytical

instrumentation: HPLC, UV/VIS, FTIR, KF and GC. Working knowledge in UPLC, LC-

MS, GC-MS, GPC and NMR

Design preformulation experiments involved characterization techniques such as: XRD,

DSC, TGA, SDT, IMC &Hot Stage Microscopy, SEM, DMA and Particle size Analyzer

PROFESSIONAL EXPERIENCE

Post doctoral research involved synthesis and characterization of new silicon based

hybrid inorganic/organic polymers, at William Paterson University, Wyane, NJ (2011-

Present)

Senior Scientist Teva/Barr Pharmaceuticals (2005–2010)

● Audit a variety of methodologies in analytical R&D areas as applied to various stages

of pharmaceutical development. Audits, and reviews laboratory data generated by the

group. Verify accuracy of data into reports, and evaluate the stability results and trend

for regulatory requirements.

● Internal laboratory audits, discuss issues with lab as discovered during final report

auditing, identifying potential compliance issues, finding of laboratory investigations,

deviations and implements corrective actions to prevent them. Monitoring the internal

quality systems to ensure compliance with FDA

● Audit Instrument calibration to ensure accurate readings, train others in SOP’s, non-

conformances, internal and external corrective and preventive action plans, e nsure

release of numerous FDA approved products timely to meet deadlines and response of

FDA comment letters using precise analytical skills to meet paragraph IV requirements

● In-depth knowledge of USP, BP, ICH, GLP, FDA, DEA requirements and responsible

for adherence to Federal, OSHA regulations, cGMP’s, SOP’s and company policies and

procedures

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Tazin Mahnaj

Method Development Scientist Barr Pharmaceuticals

(1997- 2005)

● Performed development of analytical methods for drug substances and finished

products. Validate of analytical methods to provide supports for

formulation and development groups and transfer activities of assigned

projects

● Experienced in analytical method validation for dissolution, potency, related

compounds, residual solvents and stability indicating methods for raw materials and

finished products and compare equivalency with the reference listed drugs

● Performed vendor’s method qualification, raw material release, bio-equivalency in-

vitro dissolution profiles for immediate and extended release products to support the

formulation group and co-ordinate the product development activities of innovated drug

products

● Experienced in process validation for scale up and bio/submission batches to release

results of new products. Performed cleaning method validation for manufacturing

equipment’s to meet the acceptance and validity criteria

● In-house standard qualification and calibration of analytical instruments like HPLC,

UPLC, GC, LC-MS, Dissolution apparatus, UV-VIS. Conduct instrument troubleshooting

and capable of troubleshooting analytical methods

● Performed stability testing for R&D products and monitored stability results and

identify trends for ANDA submission . Assist quality control department to modify and

improve existing methods and performed analytical test method transfer to QC

department

● Authored and executed method validation protocols, reports, standard operation

procedure and regulatory submission documents for different products. Prepare ANDA

stability reports, coordinate and manage analytical documentations to support the CMC

section of regulatory submissions

EDUCATION

Ph.D. in Pharmaceutical Sciences (2010), Arnold & Marie Schwartz College of

Pharmacy and Health Sciences, Long Island University, NY

Thesis: “Study the Effect of Various Chemical Groups of Plasticizers on the Ethyl

Cellulose Polymer Film for Evaluating their Plasticizing Efficiency”

M.S in Chemistry (1991) Department of Chemistry, University of Dhaka, Bangladesh

Thesis: “Adsorption of Polyvinyl Alcohol from aqueous solution of Attapulgide clay

colloid”

B.S in Chemistry (1989) Department of Chemistry, University of Dhaka, Bangladesh

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Tazin Mahnaj

PROFESSIONAL DEVELOPMENT

● Ph. D Research: Physical characterization of ethyl cellulose polymer and polymeric

films with different plasticizers.

● Evaluate the physical properties of pharmaceutical solids using XRD, DSC, TGA

FTIR, SEM and DMA techniques Long Island University (2006 –2009)

● Research Assistant/Tutor in the Department of Pharmaceutical Sciences/ Academic

Reinforcement Center Long Island University (1993 – 1997)

PRESENTATION AND PUBLICATIONS

H. Ahmed, T. Mahnaj and R.J Mannan. “Adsorption of PVA from Aqueous solution of

Attapulgide clay colloid” was published on Dhaka University Studies, B 37(1)75-81,

1989

T. Mahnaj, S.U. Ahmed and F.M. Plakogiannis. “Evaluating the efficacy of a group of

nontraditional plasticizers on the glass transition temperature of ethyl cellulose polymer”

in Drug Development and Industrial pharmacy, March 2011, Vol. 37, No. 3, Pages 342-

350 (doi:10.3109/03639045.2010.513390)

T. Mahnaj, S.U. Ahmed, R.H. Dave and F. M. Plakogiannis. “Effect of Various Groups of

Plasticizers on Ethyl Cellulose Film” Journal of applied polymer science- under review

T. Mahnaj, S.U. Ahmed and F.M. Plakogiannis “Characterization of Ethyl Cellulose

Polymer”. Pharmaceutical Development and Technology – under review

T. Mahnaj, S.U. Ahmed and F. M. Plakogiannis. “Plasticizing Performance of

Tricarboxylic Acid Derivatives: Effect on Glass Transition Temperatures” Manuscript to

be submitted

PROFESSIONAL AFFILIATIONS

● American Association of Pharmaceutical Scientists (AAPS) 2004–Present

● American Chemical Society (ACS) 2008- Present

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Tazin Mahnaj

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