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Sr. Formulation Scientist Resume Example

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SR. FORMULATION SCIENTIST
Professional Summary

​​Formulation Scientist with project level responsibilities in Research and Development for Pharmaceutical Industry. Extensive experience as individual contributor in the areas of R&D, project management and supervision involving transfer of Research and Development drug processes into manufacturing for high volume production.

Key Strength
  • More than 5 years of solid oral dosage formulating experience with emphasis in Pharmaceutical Industries.  
  • Worked on IR, ER and Delayed release Tablets and Capsules formulation. 
  • Knowledge related to the formulation production theories, methods, improvements and developments. 
  • Worked on 6 ANDA paragraph IV projects. Responsible for filling 3 ANDA.
  • Evaluate data generated from formulation studies, recommends critical processing parameters, manufacturing process and proposed specification.
  • Knowledge of QbD, cGMP, GLPs, FDA Guidelines, SOPs, Controlled Substances Handling Procedures and other regulatory requirement governing pharmaceutical manufacturing.
  • Thorough understanding of GMP guidelines, QA documentation, Planned and unplanned Deviation and SOPs with respect to company.
Skills
  • Develop robust formulation. 
  • Design and Execute Quality by Design.
  • Technology Transfer.
  • Preparation of Product development report. 
  • Operation and Set-Up of Korsch Compression press (Single layer & Bi-layer).
  • Operation and Set-Up of Fluid bed processors (Top spray and Bottom spray).
Education
Master of Science: Chemistry , 2012
 Murray State University - Kentucky, USA
Bachelor of Science: Pharmaceutical Science, 2009
 Rajiv Gandhi University of Health Sciences - Karnataka, India
Work History
Sr. Formulation Scientist, 06/2012 to Current
 Guardian Drug Company – Dayton, NJ
  • Responsible in designing and conducting formulation development experiments leading to development of patent non-infringing and/or bioequivalent products (Immediate-release, controlled-release and sustain-release oral dosage form).
  • Evaluate process and formulation variables to develop robust formulation.
  • Developed process for tablet and pellet manufacturing employing a variety of pharmaceutical manufacturing techniques, include high shear and low shear granulation, roller compaction and Fluidized bed granulation.
  • Experienced with numerous related pharmaceutical process, including blending, milling, compressing, coating, and encapsulation.
  • Experience related to formulating bilayer tablets, matrix tablets, tablets in capsules, micro tablets in capsules, coated sugar beads in capsules, pellets in capsules etc. 
  • Prepared pivotal batches for clinical studies and registration for several dosage form.
  • Prepare and review BMR/MMR; Product Development Report (PDR), Process Characterization/Validation Protocol and Reports, Quality Overall Summary (QOS) and other necessary documents to support ANDA filing.
  • Collaborate with Business Development, Project Management, Process Engineers, Manufacturing Operators, Quality Control, Microbiology, Validation, QA and Regulatory department to coordinate Pilot, registration and commercial batch manufacturing.
  • Provide vital input in Scale-up and technology transfer process in collaboration with Manufacturing Plant and Production personnel.
  • Holds responsibility of coming up with new techniques and procedures for finding out appropriate resolutions for the technical issues regarding formulation.
  • Executed multiple R&D Projects in a fast paced generic environment. Product development, pre-formulation and formulation design. 
  • Successfully executed and supervised Pivotal, Pilot and ANDA batches with reference to the QbD and guidelines provided by the FDA.
  • Conduct literature searches to support formulation development.
  • Actively involved in investigation, troubleshooting and resolving issue related to formulation studies and/or R&D pilot manufacturing.
  • Recommends the purchase of new equipments for Pharmaceutical Research and Development; assist in installation and qualification of new equipments.
  • Initiates and monitors stability data for assigned projects.
  • Direct and coach product development summer intern's students in areas such as safety, basic research, technology development and application. 
  • Coordinated with the Engineering, Analytical and Production teams during Process Engineering and ANDA execution batches.
  • Collaborated with suppliers and purchasing team to order samples for early formulation work, secure CoAs for materials prior to establishing specifications and ordering for pilot batch supplies.


  • Participated in Stability / Process Validation & exhibit batch sampling during compression, encapsulation, coating & packaging of finished product. 
  • Verified and approved the protocols for Installation Qualification, Operational Qualification and Performance Qualification. 
  • Planned and executed stability studies and excipient compatibility studies. 
  • Created formulas, gathered and inspected raw materials and equipments, developed processes, supervised/ made scale-up, test and production batches. 
  • Prepared and submitted product development reports to FDA for various approvals. 
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Resume Overview

Companies Worked For:

  • Guardian Drug Company

School Attended

  • Murray State University
  • Rajiv Gandhi University of Health Sciences

Job Titles Held:

  • Sr. Formulation Scientist

Degrees

  • Master of Science : Chemistry , 2012
    Bachelor of Science : Pharmaceutical Science , 2009

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