analytical Scientist

Astha Christian **************@*****.*** 646-***-****

Objective:

To obtain a post entry level Analytical R&D position in a growing Pharmaceutical Institution where I can use my knowledge and Personal

experience to help the Institution develop further and flourish my knowledge along with.

Education:

Long Island University, Brooklyn, NY

M. S. Pharmaceutical Sciences and Industrial Pharmacy, May 2012

Specialization: Cosmeceuticals, Aerosol Technology

Skills:

• Execute Wet chemistry tests and Instrumental analyses to ensure the products meet the criteria for identity, purity, strength and physical

characteristics they are desired to possess.

• Adept in operation, instrumentation and troubleshooting HPLC, AAS, UV/Vis, Karl Fischer, Dissolution Baths.

• Competent in Compendial( USP/EP/JP) tests and In house tests.

• Ability to work in team environment and individually.

• Self-starter, quick learner, multi-tasker.

• Acquainted with SOPs. GMPs, GLPs, FDA regulations and CFR guidelines.

• Proficient in MS-Office Suite.

• Softwares known- Chromeleon, ChemStation, SpectrAA, Empower, Rheology Advantage

Experience:

Scientist I

Amneal Pharmaceuticals, Piscataway, NJ January 2014-

• Carrying out Assay, Impurities, Content and Blend Uniformities and Dissolution by HPLC for Stability (ANDA) Batches of

Suspensions, Transdermal systems, Ointments and gels.

• Performing various Physical tests like Sieve analysis, Viscosity ( by Rheometer and Viscometer), Density, Osmolality, etc.

• Performing various Dosage form specific tests like Adhesive migration, Peel Adhesion, Release Liner Peel, etc for TDS.

• Carrying out Method Validations and assisting in report writing for the same.

• Calibration of HPLCs, Dissolution Baths.

• Maintaining In house Solid Reagent Inventory

• Perform Raw Material analyses using Wet chemistry when needed

• Maintain accurate Lab Notebooks and records according to GLP requirements.

• Training Interns and colleagues.

Associate Scientist June 2013-October 2013

SGS Life Sciences, Fairfield, NJ

• Assay, Purity and Dissolution Method validations and verifications.

• Trace Metal analyses by Atomic Absorption Spectroscopy ( Flame/ Graphite Furnace)

• Compendial testing for Raw materials and Finished Products (USP/EP/JP)

• Operation and troubleshooting of KF( Gravimetric/Titrimetric), UV/Vis, AAS, HPLC (Agilent)

• Extractable and Leachable testing

• Assist in report writing for Extraction and Leachables Projects

• Peer review of raw data

• Maintenance of AAS, Dissolution baths

• GMP documentation and data entry-LIMS

• OOS Investigations, Root cause determinations, Change Controls

Associate Scientist September 2012-May 2013

Novartis-SGS FTE Project, East Hanover, NJ

• Carrying out Assay, Impurities, Content and Blend Uniformities and Dissolution by HPLC for Stability (NDA) and Clinical Release

Batches of Tablets, Capsules, Powders, Suspensions.

• Assisting in manufacturing of developmental scale batches for NDA formulations

• Assisting in troubleshooting if any while optimizing the formulation

• Carrying out dissolution profiles and comparison studies for the developed formulations

• Assist in report writing and data compilation for the analyses carried out

• Carrying out Method Validation

• Operation and troubleshooting of KF, UV/Vis, HPLC( Agilent/Waters), Dissolution Systems( Apparatus I, II, IV)

• GMP Documentation and data entry-LIMS

Associate Scientist May 2009-August 2009

Cadilla Pharmaceuticals, Gujarat, India

• Assist in Pre-Formulation and development of Zydovudin.

• Manufacturing Lab Scale batches.

• GMP Documentation

Internee May 2008-August 2008

Cadilla Pharmaceuticals, Gujarat, India

• Trained in Pre-formulation and formulation development of Solid/Liquid dosage forms at Lab scale

• Trained in operation of UV/Vis, HPLC

• Trained in routine QC testing

H1B Transfer required

References Available on request

Contact this candidate