Manufacturing Process

DIMPLE MODI

************@*****.*** 201-***-****

OBJECTIVE:

With my hard work and dedication, I want to reach the position where I am respected in a professionally

managed Pharmaceutical company/ organization that can provides me growth & opportunities.

SKILLS:

• Proficient with Microsoft Office suite: Word, Excel and PowerPoint.

• Ability to draw graph, charts, and DOE models as per lab report using Minitab software. Also familiar

with M-file

• Knowledge and Practical Experience of HPLC calculation by using Empower3 Software.

WORK EXPERIENCE: (As a Formulation Scientist in Specialty Product Development)

NOVEL LABORATORIES INC. Somerset, NJ (March 2012

-Current)

• Performed Formulation of Semisolid Dosage forms like ointment, gel, paste, cream, emulsion, liquid

solution, suppositories.

• Performed pre formulation studies of Topical products using different experiment like solubility study,

pH study, specific gravity study and viscosity study.

• Worked on different equipment like, homogenizer, Auger filler, v-blender, co-mill, granulator,

planetary mixer, tube filler.

• Performed manufacturing of Submission Batch of topical products following cGMP guidelines.

• Prepared Manufacturing batch record and packaging record of related Topical drug product’s Exhibit

batch.

• Prepared product development report on different Semisolid Dosage forms.

• Comprehensive working knowledge of QTTP, QbD, QbR and DOE.

• Established process control parameters by understanding the process parameters during lab scale

experiments.

• Accompanied in troubleshooting of equipment, process problems and supporting for in- process

improvement efforts

• Ensuring and Maintaining the highest cGMP compliance & inspection readiness, Managing production

activity

• Remained current with and complied fully with cGMP, in-process specs & limits which helped to

recognize deviation from procedures & production records

• Accompanied in collecting & analyzing data to identify root cause in failure investigation and in

recommending CAPA.

• Performed pilot scale batch based upon process parameters of lab scale batch and improved process

control steps.

• Performed physicochemical characteristics of Topical drug product and related excipients and API.

WORK EXPERIENCE: (As a Analytical R&D Analyst)

NOVEL LABORATORIES INC. Somerset, NJ (August 2011-Feb

2012)

• Performed Dissolution, Disintegration, Friability and Hardness tests for in-process and finished

products.

• Performed Dose Dumping Study for Different Drug Product.

• Performed physical & chemical testing and approval of raw material, in-process and finished products.

• Analyzed sample by using HPLC, TLC, UV and IR Spectroscopy and documented results according to

cGMP.

• Conducted calibration of the lab equipment like PH meter and Weighing Scale.

• Maintained documents according to GLP guidelines and updated log files regularly..

• Performed Assay Analysis, Weight Variation and impurity analysis of in-process and finished

products.

• Analyzed the sample by performing content uniformity, blend uniformity and bench chemistry.

• Performed Karl-Fisher Technique for Moisture content products and also performed pH test and

alkalinity tests.

• Performed Method Validation using different techniques like Accuracy, Precision and Robustness.

EDUCATION:

Stevens Institute of Technology, Hoboken, NJ

Master of Science in Pharmaceutical Manufacturing Practices, May 2011

GPA: 3.43/4.00

Coursework: Regulation and Compliance in Pharmaceutical Manufacturing, Good Manufacturing

Practices in Pharmaceutical Facility Design, Validation and Regulatory Affairs, Quality in Pharmaceutical

Manufacturing, Design Management of Aseptic Pharmaceutical Manufacturing Process, Project Management,,

Contemporary Concept for Pharmaceutical Manufacturing.

CERTIFICATIONS:

• “Validation and Regulatory Affairs in Pharmaceutical Manufacturing”.

• “Pharmaceutical Manufacturing Practices”.

PROJECTS:

• “Ethical Implications of buying off generic competition”, focused on ethical problem, its 7 step model and

legislation.

• “Standard Operating Procedure of design, construction, installation and commissioning of new aseptic

facility”.

• “Root cause analysis, Six Sigma and Lean Manufacturing, FMEA and CAPA” study in manufacturing p

process.

• “Developed manufacturing process and defined Critical Quality Attributes of manufacturing of drug

product”, serving as a Process Development Scientist in the project and preparing Process Flow Diagram,

Master Batch Record, and Process Development Report.

• Completed laboratory practices on process development, analyzed its critical quality parameters.

• Cleaning validation study with swab sampling method and TOC analysis.

• Clinical study on Rates and Rabbits using different dose of the drugs.

• Worked on a project of Formulation and Evaluation of microsphere using Aspirin Drug.

• Sound understanding of “Preparation and Evalution of Transdermal Patch ”

L.M. College of Pharmacy, Ahmedabad, Gujarat, India

Bachelor of Science in Pharmacy May 2009

Rank: First Class

Coursework: Pharmaceutical Chemistry & Applied Biochemistry, Pharmaceutical Analysis,

Pharmaceutical Engineering, Pharmaceutics and Dispensing Pharmacy, Pharmaceutical Microbiology,

Biotechnology and Dosage Form Design, Pharmacology & Clinical Pharmacy.

Activities:

• Industrial visits – Stryker Corporation (USA) and N.K Pharmaceuticals (India).

• Participated in Stevens Pharmaceutical Research Center at Stevens Institute of Technology (New

Jersey).

• Assisted Federation of Gujarat States Chemists and Drugs Association (India) in collection of drug

samples for analysis.

Contact this candidate