ANITHA CHIDIPOTHU
Tampa,USA
Summary
18+ years of technical experience and possess extensive knowledge in the Research & Development Formulation and Production of Oral Solid dosage forms and liquid dosage forms for regulatory markets as per current guidelines. Presently seeking a challenging position that utilizes my technical and innovative skills while providing career advancing opportunities with effective utilization benefiting the organization and to gain a chance to be trained in new horizons.
Overview
13
13
years of professional experience
Work History
Associate Director
BELCHER PHARMACEUTICALS INC
08.2022
- Directs junior level scientists and managers and responsible for development of Oral solid dosage forms and liquid dosage forms of Non- DEA and DEA substances, literature search, Pre-formulation, formulation design, Scale-up batches, ANDA batches and development of stable, bioequivalent, and manufacturable generic Solid and liquid dosage forms
- Coordinates and responsible for working with cross-functional departments such as AR&D, QC, QA and RA
- Directs junior level scientists and managers and responsible for providing complete documentation (QBD/QBR/DOE software/Hold time study protocol and report/Split study protocol and report/Summary report/Comparative dissolution report/Bio summary report/Intended Batch records/Intended Batch Packaging records/IIG/Stability protocols/Stability compilations/Process validation protocols/Stratifies sampling protocols etc.,) required to RA in timely manager to support ANDA filings and supplement filings as and when required
- Excellent knowledge and responsible in Project Management activities for timely completion of company Targets
- Expertise in the areas of formulation development, formulation optimization Process development studies, Process optimization studies, Scale Up batch execution, technology transfer, cGMP batch executions (ANDA), Process validation and production activities
- Directs and guides junior level scientists and managers in performing the IQ/OQ/PQ activities of Production equipment’s
- Excellent knowledge in Trouble shooting of formulation related activities and in process related activities at manufacturing scale
- Directs junior level scientists and managers and responsible for Validation Batches executions and in Validation protocols and Stratified Sampling protocols
- Expertise in communicating or coordinating with site transfer projects and responsible in timely completion of the Projects.
Associate Director
POLYGEN PHARMACEUTICALS INC
03.2016
- Expertise professional in the areas of formulation development, formulation optimization Process development studies, Process optimization studies, Scale Up batch execution, technology transfer, cGMP batch executions (ANDA), Process validation and production activities
- Expertise professional in writing, reviewing and approving of Master batch records, Master Packaging records, SOP’s, Hold time study protocol and reports, Process validation Protocols and reports, Specifications, Stability protocols, Change controls, IQ/OQ/PQ for Production equipment’s
- Exceptional experience in Trouble shooting, guiding, and managing all pharmaceutical development and production challenges
- Experience in designing the experiments independently and guidance to the team
- Observe the data trend during the developmental stage/Validation stage for the development of Pharmaceutical oral solid dosage forms
- Experience in QBD during the development of Pharmaceutical oral dosage forms
- Coordinating with the outside suppliers, CMO’s for site transfer projects and interact with cross functional teams for timely completion of the project
- Prepare, Review and report the necessary documentation to support regulatory filings such as ANDAs etc (QBD/QBR/Commercial Documentation etc.)
- Bio equivalent strategies for achieving desired pharmacokinetic response in new dosage form design and product development research
- Modulation of drug release in multimedia including bio relevant media, selection of suitable API particle size, polymorphic form along with curing commercially feasible manufacturing process
- Presently working on some Nutritional products, formula finalization and Scale up batches executed.
Assistant Manager
SCIEGEN PHARMACEUTICALS INC
01.2012 - 03.2016
- Manages/Directs and Performs Preformulation studies, prototype formulation research and process development, process feasibility, scale up studies and technology transfer to the shop floor for the commercial production with documentation and subsequently validation with respect to process and product performance
- Prepare / Review and evaluate the documents/records viz
- SOPs, Specifications, Master Formulae, Batch Production Records, Batch Packaging Records, Stability Protocols etc
- Prepare, Review and report the necessary documentation to support regulatory filings such as ANDAs etc (QBD/QBR/Commercial Documentation etc.)
- Review and approval of change controls related to the manufacturing and analytical changes and updates
- Review of manufacturing and analytical documents before the exhibit batch (Like BMR, BPR, Stability protocol) etc
- Exceptional experience in Trouble shooting, guiding and managing all pharmaceutical development and production challenges
- Coordinating with the outside suppliers, CMO’s for site transfer projects and interact with cross functional teams for timely completion of the project
- Prepare, Review and report the necessary documentation to support regulatory filings such as ANDAs etc (QBD/QBR/Commercial Documentation etc.)
- Bio equivalent strategies for achieving desired pharmacokinetic response in new dosage form design and product development research.
Production Manager
ALAPATI PHARMA
06.2009 - 04.2011
Assistant Manager
Dr. REDDY’S LABORATORIES LTD
06.2007 - 05.2009
Research Associate-III
AUROBINDO PHARMA RESEARCH PRIVATE LIMITED
05.2004 - 06.2007
Project Trainee
ORCHID CHEMICALS & PHARMACEUTICALS
05.2003 - 04.2004
- Worked on Enhancement of Bioavailability of Verapamil hydrochloride through nasal route by Freeze-Drying technique.
Education
Master of Pharmacy (M. Pharm.) - Pharmaceuticals
Dr. MGR Medical University
01.2004
Bachelor of Pharmacy (B. Pharm.) -
Bapatla college of pharmacy
01.2001
Skills
- Proposal Writing
- Database Management
- Program Development
- Strategic Leadership
- Process Improvement
- Project Management
- Analytical Thinking
- Team Collaboration and Leadership
- Professional Networking
- Decision-Making
- Work Planning and Prioritization
- Critical Thinking
- Coaching and Mentoring
- MS Office
- Budget Development
Personal Info
Green Card, 12221 Lexington Park Drive, Tampa, Florida, 33626
Work Experience Highlights
Excellent exposure in developing of Oral solid dosage forms and liquid dosage forms for US and Europe markets using QBD. Responsibilities range from day-to-day monitoring of formulation development activities to documentation. Responsibilities encompass actively liaised between departments such as, Analytical Development, Stability, Technical Services, Planning, Change Control, Production, Packaging, Purchasing, Quality control for speed up of activity. Perform/ Plan/ Execute Equipment qualifications related to R&D and Production. Documentation includes establishing Master formulae, manufacturing process, Sampling Plan, Hold time study, split study, Validation protocols, stability protocols, product development reports, product, and process specifications for regulatory filling. Excellent Exposure in technology transfer for scale up batches of Oral solid Dosage Forms and liquid dosage forms. Critical monitoring of product/ Process characteristics of development batches to develop a robust product that is scalable at production plant.
Timeline
Associate Director
BELCHER PHARMACEUTICALS INC
08.2022
Associate Director
POLYGEN PHARMACEUTICALS INC
03.2016
Assistant Manager
SCIEGEN PHARMACEUTICALS INC
01.2012 - 03.2016
Production Manager
ALAPATI PHARMA
06.2009 - 04.2011
Assistant Manager
Dr. REDDY’S LABORATORIES LTD
06.2007 - 05.2009
Research Associate-III
AUROBINDO PHARMA RESEARCH PRIVATE LIMITED
05.2004 - 06.2007
Project Trainee
ORCHID CHEMICALS & PHARMACEUTICALS
05.2003 - 04.2004
Master of Pharmacy (M. Pharm.) - Pharmaceuticals
Dr. MGR Medical University
Bachelor of Pharmacy (B. Pharm.) -
Bapatla college of pharmacy
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