AKHILA SEN GADDAM

940-***-****

** ********** ******

New Brunswick, NJ, 08901 abnzi1@r.postjobfree.com

OBJECTIVE: To obtain a position with a growth oriented organization, which will enable me to utilize my knowledge,

skills, and help me exercise my interpersonal and professional skills to the fullest for the growth of the

organization and mine as well.

EDUCATION: NEW JERSEY INSTITUTE OF TECHNOLOGY, Newark, NJ

Master of Science in Pharmaceutical Engineering (Chemical Engineering), May 2012 GPA 3.8/4.0

UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES, KAKATIYA UNIVERSITY, AP, India

Bachelor of pharmaceutical sciences, May 2010 GPA 4/4

TECHNICAL SKILLS:

• Strong Analytical and problem solving skills and experience with formulation development.

• Ability to test plans and protocols like the IQ, OQ, PQ, URS, DS and quality tools like FMEA, DOE etc.

• Hands on experience in performing chemical analysis using HPLC-UV/CLND, TLC, UV/VIS, protein

characterization ELISA, techniques and in operating lab scale formulation/production equipment.

• Ability to follow the current GMP, GLP, GCP practices, the 21 CFR, ICH Q7, Q8 according to the FDA

guidelines and also received extensive training on the OSHA and EPA, QbD guidelines.

• Sound knowledge in the areas of unit operations for the solid, liquid and dispersion phase systems like the sterilization,

filtration, mixing, centrifugation, solid particle properties and calculation of pharmacokinetic parameters.

• Can Evaluate the PK/PD models and make reports interacting with the other corresponding departments.

EXPERIENCE: FORMULATION SCIENTIST (R&D) IN US PHARMA LAB INC, NJ 03/2012 – Till Date

• Planning, performing and optimizing laboratory experiments to develop formulations and manufacturing processes.

• Stability studies for the excipients, products and documentation of all the lab reports, experience with manufacture of

softgel, tablets, capsules (non-prescription drugs) and also prepare price quotes working towards ways in reducing the costs.

• Write the product specifications, protocols and make batch cards by performing scientific studies using all the appropriate

methodologies, formulating the hair and skin care products.

• Proof reading the labels prepared and also on the design for packaging also worked on poorly soluble and new chemical

entities and also with the scale up manufacturing and market research of the current products.

NEW JERSEY INSTITUTE OF TECHNOLOGY, NEW JERSEY (RESEARCH ASSISTANT) 05/2011 – 12/2011

• Process validation for the moist heat sterilization for pharmaceuticals products was conducted.

• Validation protocols were developed and made sure all the approaches used for validation were meeting the needs of the

requirements stated in the protocols.

• Sterilization cycles were developed using two basic methods that are the over kill and the probability of survival keeping in

mind the minimum safety factor and the F,D,Z values were calculated for process optimization

• Also worked on different analysis procedures in explaining the effect of baffles on the rate and extent of mixing.

INTERN AS QUALITY CONTROL SCIENTIST NAIK PHARMACEUTICLAS, INDIA 12/2009-05/2010

• Participated in the preparation of quality control reports, SOP meeting all the quality standards i.e quality assurance

• Supported certain external departments like the process improvement, CAPA’s, failure investigations, underwent training to

keep the skills current by attending GMP, safety, job specific other sessions.

• Developed knowledge on the methods for pH analysis, calibration of equipment, preparation of different solutions and

samples including statistical analysis, cell culture and cell based technologies

ANAYTICAL RESEARCH ASSISTANT, KAKATIYA UNIVERSITY, INDIA 01/2007 - 01/2009

• Performed drug product testing for cancer drugs utilizing High Performance Liquid Chromatography (HPLC) and Thin

Layer Chromatography (TLC), performed moisture determination using Karl Fischer Coulometric Titration and also

obtained familiarization training on Gas Chromatography (GC-MS) and other automated equipment

• Measuring Brookfield viscosity, pH and other parameters contributing for the stability of products

PROJECTS: DRAFTING USER REQIREMENT SPECIFICATIONS AND PROTOCOLS FOR STABILITY CHAMBER

• Helping the project engineer in creating a user requirement specification document and a protocol listing IQ, OQ and PQ tests for

equipment (environment chamber) bought by NJIT using GLP and GMP techniques.

FORMULATION OF CONSUMER PRODUCTS LIKE SKIN CARE AND SHAMPOOS

• Developed different formulations using the latest cosmetic technological studies on lab scale and in testing the products on

microbiological basis

PACKAGING TECHNOLOGY USED FOR INSULIN

• All the latest technology used for packaging of insulin was described and research was done on the different kinds of

formulations of insulin available in the market with emphasis on the insulin pens and the aid of colors(Secondary

Packaging) in optimizing the use of insulin.

ACTIVITIES:

• Member of American Association of Pharmaceutical Scientists ( AAPS), International Society of Pharmaceutical Engineers

(ISPE)

• Presented “NOVEL DRUG DELIVERY SYSTEM” in national level technical paper presentation and was selected as the

best paper and also received a certificate of appreciation for my presentation on drugs from plant (Pharmacognosy).

• Gold medalist for the year 2010 in my university.

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