Hardik Shah

* ******* ****, *** # **

acee00@r.postjobfree.com Wallington NJ-07057 Cell# 973-***-****

Objective: Obtain a position in Pharmaceutical or Biopharmaceutical company where I can utilize my technical

knowledge, skills and experience towards the growth of organization.

Work Experience:

Roche Molecular system, Branchburg NJ June 2013 - Present

Scientist I

• Conduct and monitor production activities or laboratory experiments utilizing established and published

procedure with technical understanding and knowledge.

• Responsibility for the accuracy, quality and timeliness of production work or experimental results.

• Summarize batch result and reviews and communicate results of experiments within the group and

inform the work status to manager with stability status and report.

• Collect and perform statistical analyses of production process parameters with established statistical

process control parameters, process capability. Process qualification IQ,OQ, and PQ.

• Analyses and interpret test results, experimental data using various data analysis software (Minitab -16)

spreadsheets with quantative methods. Perform process validation for the process and equipment.

• Perform testing analyses of lysis the cell, Protein determination, Enzyme activity and western blot

technique(SDS –PAGE) with Gram stain technique and CAPA determination.

Abon Pharmaceuticals, Northvale, NJ Nov 2010-May 2013

R & D Chemist

• Analyze, review and document analytical data in compliance with regulatory, GMP and departmental

SOP requirements.

• Perform analytical testing such as Assay, Impurity, Dissolution, Content uniformity, Blend uniformity,

Physical testing of variety of dosage forms (Tablets, Capsules, Injs)

• Performed operation of HPLC (Waters 2695, Agilent, Shimadzu- Empower) UV spectrophotometer, FT-

IR, KF Titrator, UV, Dissolution App I & II, Automated Dissolution, Flow through Cell, Viscosity,

preparations of chemical solutions.

• Trains and mentor other analyst and assist in development-approval of Process Validation/Qualifications

IQ,OQ, and PQ.

• Perform and review of analytical technical documents (Technical Justifications, Specifications, Methods,

Transfer Protocol, Reports Method validation, CAPA etc.

• Design and Conduct stability studies, perform stability tests and perform trouble shooting activities.

• Responsible for ensuring that testing is completed following all standards for quality and timeliness and

ensures GMP compliance and review product related deviations and change control.

Community Blood Services, Paramus, NJ Nov 2010 - Till present

Comp. Associate (part –time)

• Checking for antigens and antibodies with the equipment and tests with labeling and storing blood.

• Make Cryo batch and do the QC for blood samples.

• Establishing the defining the process for cGMP personnel to follow with regards to inspection support.

• Establishing audits plans and conducting internal cGMP audits.

• Revising or providing input for the revision of SOPs that include cGMP activities.

Teva Pharmaceuticals, Pomona, NY Aug 2010 – Nov 2010

R & D Associate

• Manage the inventory of all the Controlled substance samples for R & D testing.

• Inventory management and monitoring and review of the temperature chart for stability records.

• Research associates prepare technical reports, summaries, protocols, and quantitative analyses.

• An incumbent maintains familiarity with current scientific literature and contributes to the process of a

project within scientific discipline, as well as investigating, creating, and developing new methods and

technologies for project advancement.

• Responsible for identifying patentable inventions and acting as principal investigator in conducting own

experiments.

Emcure Pharmaceuticals, East Brunswick, NJ Sept 2008 - July 2010

Formulation Chemist

• Formulation development for generic drug products.

• Expertise in solid oral dosage form manufacturing like Tablet, Hard gelatin capsule, using wet

granulation, dry granulation technique and hot melt extraction.

• Proficiency skills like tablet coating, fluid bed coating, Tablet press, granulation, milling and blending

techniques.

• Manufacturing scale up batches based on laboratory scale batches using scale up equipment of prototype

product formulations and assist to production level batches for ANDA formulation.

• With support of senior personnel, develop formulation and processes that are reproducible, scalable,

troubleshooting, and validation under current FDA guidelines.

• Write and maintain documentation to support process and formulation developments efforts.

• Familiar with FDA, ICH, cGMP and other Guidelines like OSHA and apply guidelines as appropriate.

• Familiar with requirements of various pharmacopeias (USP, EP) basic regulatory requirements and

applies knowledge appropriately to activities.

• Prepares Technical reports, Batch records, Protocols, PDR and submit to Regulatory Department.

• Drafts, reviews, and revises department SOPs and other technical documents.

• Handling of equipment like high shear granulator, fluid bed drier, co-mill, V- blender, compression

machine, coating machine, FLM-3, MG-2 capsule filling machine, chilsonator, GPCG -2, Dyno

mill(Nano particle) Extruder and spheronizer, roller compaction, and tablet compression.

Unichem Pharmaceuticals, Goa, India May 2007-July 2008

Production Supervisor

• Promote department goals by selecting, motivating and training staff and perform individual contributor

task.

• Trouble shooting of manufacturing and coordinate with ware house, quality assurance and quality

control department.

• Interprets specifications, prints, and job orders to workers, and assigns duties.

• Excellent management skills and to ensure that all product that are assign to them will be made into

grain.

• To ensure that the output is in good quality and have a good record of the work so that they are not

missing out of productivity.

• Production and packaging planning and implementation.

Education:

Rajiv Gandhi University of Pharmacy, Bangalore, India April 2007

Bachelor in Pharmacy

Stevens Institute of Technology Graduation: May 2013

Master of Science in Pharma Manufacturing (Validation, Six sigma, Lean, QBD, PAT, Risk Management,

FMEA, Project management skills, Cleaning validation -TOC)

Current GPA: 3.6

Human Aspects of Project Management: Team Dynamics- Bruce Tuckman, Emotional Intelligence- Myers-

Briggs, Conflict Modes of Behavior- Thomas- Killman, Personal Focus type: ESTJ

AFFILIATE:

• Registered Pharmacist of Gujarat, India.(R ph)

• Associate of Indian Pharmaceutical Council ( IPC)

• ISPE member

• Toastmaster Member

Contact this candidate