Project Manager Quality Control

Dharti Tank

Formulation R and D intern

Tedor Pharma Inc.

Cumberland Phone: 201-***-**** Email ID: **********@*****.***

OBJECTIVE

Procure a position in Pharmaceutical Industry and to contribute my knowledge for the growth of the company while I

acquire the knowledge to excel in the field of Product development.

PROFESSIONAL SUMMARY

An efficient and methodical R&D associate with 2+ years of Industrial and Laboratory experience in Formulation

R&D and QC for development and analytical characterization of powder for suspensions tablets and capsules.

Product development: Solid state characterization, Drug-Excipient Compatibility Studies, Preformulation studies,

Tablet Compression, Determination of end point of wet granulation using powder Rheometer, Thermal Effusivity

Measurement Probe and DSC.

SKILLS

Quality Test Data Management: Good Documentation skills in managing, gathering and reporting test data using

statistical tools.

Technical Skills: Tablet compression machine (manual and automated), Roller compactor, Comil (Quadro), Fluid

Bed Dryer (GPCG2), Air Jet Sieve (Alpine), FT4 Powder Rheometer, Thermal Effusivity Sensor (C-Therm

technologies), Differential Scanning Calorimeter (Q 2000), Particle size analyzer (Malvern), Type I-II dissolution

apparatus, U.V spectrophotometer, XRD, FTIR, High Pressure Liquid Chromatography.

Computer: Proficient in Microsoft Office (MS Word, Excel, PowerPoint & Outlook).

Soft skills: Time management, Communication and Organizational skills, Active member of team and ability to

accept and learn from criticism.

WORK EXPERIENCE

TEDOR PHARMA INC., Cumberland, RI (USA) March 2014 - present

Formulation Scientist I

• Performed pre-formulation and formulation studies for the product development of solid dosage forms i.e. tablets

and capsules including use of solid-state characterization techniques such as Particle size analysis (MALVERN),

pXRD, DSC and TGA

• Conducted compatibility studies of the active compounds and Excipients, Blend optimization, endpoint

determination, rheological and thermal characterization on blends various parameters affecting blending and

granulation.

• Made laboratory scale and pilot scale formulations.

• Worked on project applying scientific input and QbD approach to resolve pellicle formation that retarded

dissolution of capsule as an R&D formulator.

• Write technical documents including Laboratory Notebooks, Batch Records, PDR, Project Summaries, Sampling

and Testing Protocols, Planned Deviation Reports, Incident Reports, and Change Control forms and handled

responsibility of ensuring that records were approved.

• Managed R&D projects and reported project progress to the project manager.

• Calibrated in-process testing equipment, interpret and analyze experimental data, identified the steps to be taken

and perform scale-up and technology transfers of formulations from research and development to the

submission/clinical to production/commercial scale batches.

• Trained manufacturing operators for following cGMP, safety and protection guidance documents to prevent

accidents and injuries.

• Assisted senior management team, in launch of new product at site considering the proposed deadlines to ensure

product manufacturing started on time with validated process and qualified facility equipments.

• Interacted with service departments during new product launch on timely basis to ensure all activities takes place

as per pre schedule plan such as Validation, qualification and calibration of facility and equipments.

• Planned monthly manufacturing activity after consulting warehouse, Quality control, Quality assurance,

maintenance and utility department to ensure product deliver with no delay.

• Investigated all non-conformance and process failure within stipulated time frame to avoid further batch dispatch

to respective regulatory market ensuring that suitable CAPA action was taken and implemented.

• Learned key requirements of process validations while working in team and acquire GDP review skills from

quality experts to ensure documents meet the desired quality standard and auditor expectations.

• Compiled plant shop floor observations and contacted respective manufacturing supervisor for suitable

corrective actions to comply the observations made by IPQA team members to maintain GMP at site.

• During weekly visit to shop floor with supervisor collected suitable observations for process improvement and

cost reduction to enhance process capabilities.

LUPIN LIMITED, Ankleshwar (INDIA) May 2011 - October 2011

Quality Control Intern

• Analyzed samples obtained from primary production using SOPs to demonstrate compliance with the relevant

specifications on HPLC, GC, UV/VIS-Spectrophotometer, pH Meters.

• Ensured a safe work environment in compliance with all GMP policies and procedures using the appropriate tools

and equipment for the task.

• Calibrated and maintained laboratory equipment such as pH meters, Auto-titrators, Weighing balances in

accordance with manufacturer recommendations.

• Performed disintegration and dissolution testing on solid dosage forms.

• Drafted, reviewed and revised SOPs/Test Protocols/Methods of Analysis.

• Sampled Tablets and Capsules for API concentration by chromatography and various titration methods.

Research Experience

• Performed formulation for tablets.

• Experienced with Wet Granulation process and determining granulation endpoint by Thermal Effusivity

Technique (C-Therm Technologies) and further carrying out rheological characterization of granules by FT4

Powder Rheometer (Freeman Technology) and DSC using different diluents and binders as a Graduate Research

Student.

• Proficient in determining Granule Strength, Soft gelatin capsule rupture strength using Texture Analyzer (TA XT

plus, Stable Micro Systems Ltd)

• Experienced working in Laboratory environment following GLP.

• Experienced in HPLC analysis of various commercial available analgesic tablets, extraction of indoleamines from

fish brain and their identification using HPLC.

• Experience in isolation of aromatic compounds and terpenes from natural sources followed by its analysis using

IR and H1-NMR.

• Hands on experiencing with pH meter, disintegration tester, Brookfield viscosity meter, tablet hardness tester.

• Performed Gas Chromatography of various fatty acids from Triglycerides.

Projects and presentations:

Research Dissertation: To study effect of changes on Rheological and Thermal Properties of wet and dry granules of

Microcrystalline Cellulose (MCC 105) using different binder solutions Methocel K (Methocel K4MCR) as Wet

Granulating Agent (Spring 2014)

Advisor: Dr. Rutesh Dave

Research Articles:

Attended and presented research paper at Linnaeus ECO-TECH’ 10, Kalmar Sweden, 22-24 November 2010. Title

of Paper: Detection of lead from samples of Ocimum sanctum from industrial and non-industrial areas of Surat city-

India (Fall 2010)

Review articles:

Pulsatile drug delivery system: drug delivery in symphony with circa-dian rhythm, Deccan J. Pharmaceutics and

Cosmetology, 1(4): Oct-Dec.2010;18-40.(Available online at www.deccanpharmajournals.com, ISSN 0976 – 1403)

Nutraceuticals-Portmanteau of Science and Nature, International Journal of Pharmaceutical Sciences Review and

Research, 5 (3): Nov-Dec 2010; Article-006; 33-38. (Available online at www.globalresearchonline.net, ISSN 0976 –

044X)

EDUCATION

Master of Science in Pharmaceutics Specialized in Industrial Pharmacy and Cosmetic Science Long

Island University, Brooklyn, NY, USA GPA - 3.5/4 July, 2014

Bachelor of Pharmacy Veer Narmad South Gujarat University, India (Distinction) May 2011

Contact this candidate