Nitu Rao
Bensalem,PA
Summary
Detail-oriented professional with widely experienced in Research and Development and Quality systems; additionally excellent communicator, individual and Team contributor, good understanding of company system tools (SAP, Master controls), Document Management systems, MS Office, MS Project, Excel, SharePoint, Adobe Acrobat.
Overview
11
11
years of professional experience
Work History
Formulation SCIENTIST
KVK Tech Inc
06.2022 - Current
- Have knowledge of storage conditions, Container closure integrity, Photostability, testing as per product requirement
- Responsible for documentation of all activities as per cGMPs and cGLPs
- Analyze lab data and makes changes to subsequent experiments accordingly
- Use to create and write manufacturing batch records, scale-up batch records, cleaning verification protocols and reports
- Performed experiments leading to robust oral liquid & solid dosage forms
- Hands on experience with ophthalmic sterile formulations
- Worked on Product development reports, submission content plans, and proactively provide status updates
- Experience in coaching, mentoring and knowledge sharing to team members
- Proficient in computer software, Managing Sop's, Chemical handling
- Formulation Development of solid oral product that is Extended-Release dosage form
- Experienced to prepare Stability Protocols and stability reports as per ICH guidelines Q1A(R2) for Oral solid and liquid dosage form
- Prepared and executed container closure integrity test protocol for injectables and ophthalmic products and generated report for same
- Working on projects that includes use of sugar-coating pan, Fluid bed system
- Performed Pre-development studies of the assigned products Develops and optimizes formulation by studying the characteristic of the active ingredient and inactive excipient and their compatibility
- Experienced in making performance qualifications batch record for equipment qualifications
- Experienced to create Purchase order and Purchase requisitions for supplies using SAP system, inventoried chemicals and materials and summarized and recorded data to meet control and research requirements
- Provided technical support during validation studies conducted by external vendors or internal team members
- Maintained accurate records of all experimental work performed in laboratory notebooks
- Designed experiments using Design of Experiments principles to identify critical formulation variables that affect product quality attributes
- Coordinated activities with other departments such as Quality assurance, Quality Control and Manufacturing
- Assisted in the troubleshooting of scale-up issues related to formulations
- Ensured compliance with safety guidelines while performing laboratory experiments
Senior Formulation SCIENTIST
Torrent Pharma
07.2021 - 05.2022
- Have Designed and performed experiments leading to the development of products that includes suppository, Suspensions and solutions
- Provided leadership to scientist when appropriate
- Supported regulatory submissions as needed
- Experienced to review compendial requirement for use of excipients and patent literature
- Use to work on change controls as department initiator and revisor
- Use to Write specifications for finished products and packaging components and conduct training for same
- Designed and Initiated stability studies on selected batches of products
- Have experience to oversee the manufacturing of products using production equipment, such as batches for ANDA submissions, bio-equivalent studies, and/or process scale-up studies
- Performed product/process validation when required; including designing procedures, overseeing batch sampling, and analyzing data
- Used to coordinate with Analytical Department for completing testing of new drug products in a timely manner, and developing appropriate controls
- Coordinate scheduling and production of pilot scale and submission batches with Manufacturing Operations and Quality systems
- Supported qualification, calibration, and maintenance of R&D instruments/equipment
- Developed and maintained knowledge pertaining to cGMP documents and guidance, other FDA/ICH guidance and SUPAC guideline
- Performed other tasks as assigned by the supervisor
- Experienced to follows company policies, DEA regulations, and SOP's
Formulation SCIENTIST
KVK Tech Inc
08.2016 - 05.2021
- Perform experiments leading to robust oral solid and oral liquid dosage forms
- Operate processing equipment for weighing, blending, granulation and compression at laboratory and pilot plant scale
- Formulation Development of solid, liquid pharmaceutical products that include Sustained / Extended / Delayed Release dosage forms
- Design and conduct preformulating and formulation studies, process development and optimization of prescription dosage designs by utilizing DOE, QbD, QbR and SOPs under cGMP conditions
- Create and write manufacturing batch records, packaging records, scale-up batch records, protocols and complete Product Development reports for FDA and ANDA by interacting with manufacturing and laboratory departments
- Analyze lab data and makes changes to subsequent experiments accordingly
- Calibrations and Maintenance of all machines such as Granulators, fluid bed dryers, tablet presses, tablet coating Machine
- Performs Pre-development studies of the assigned products Develops and optimizes formulation by studying the characteristic of the active ingredient and inactive excipients and their compatibility
- Stability study is also performed Finalizes a robust formulation that is easy and reproducible in manufacturing, good stability and expecting to be bioequivalent to the innovator product
- Post formulation, solid and liquid dosage forms physical analysis using technique such as bulk density, angle of repose, flowdex, hardness testing, friability, LOD
- Pre-formulation studies of API and excipients using compatibility studies, screening, particle size analysis, COA Report Studies
- Organized, analyzed and prepared data research reports in compliance with operations and record-keeping standards
- Ordered supplies, inventoried chemicals and materials and summarized and recorded data to meet control and research requirements
- Prioritized and organized tasks to efficiently accomplish service goals
Coding ANALYST
ADVANTMED LTD
06.2013 - 09.2015
- Verified and abstracted all medical data to assign appropriate codes for hospital inpatient records
- Added modifiers as appropriate, coded narrative diagnoses and verified diagnoses
- Reconciled clinical notes, patient forms and health information for compliance with HIPAA rules
- Read through patient health data, including histories, physician diagnoses and treatments to gain understanding for coding purposes
- Reviewed account information to confirm patient and insurance information is accurate and complete
- Assigned additional diagnosis codes based on specific clinical findings (laboratory, radiology and, pathology reports as well as clinical studies) in support of existing diagnoses
- Reviewed and abstracted relevant clinical data from electronic medical records to select appropriate code for procedures
- Actively maintained current working knowledge of CPT and ICD-9 coding principles, government regulation, protocols and third-party requirements regarding billing
- Coded medical observations and professional services delivered for each patient
Education
ORAQ Regulatory Affairs Training Program
Duke University School of Medicine
2023
BACHELOR OF SCIENCE - PHARMACEUTICAL SCIENCES
M.P.Patel College of Pharmacy
01.2012
Skills
- Calibration skills
- Laboratory equipment maintenance
- Batch record analysis
- Record-keeping
- Time management abilities
- Project Management
- Data Analysis
- Report writing
- Results interpretation
- Experiment Design
- Report Preparation
- Inventory purchasing
- Technical Writing
- Team building
Instruments
- Tablet press
- Fluid bed Processer lab scale and pilot scale
- Overhead & inline Homogenizers
- Overhead stirrer
- Suppository melting point tester
- Liquid mixing tanks jacketed & non-jacketed
- ACG Coating machine
- Cone mill & Fitz mill
- Disintegration test, friability, Hardness tester
- Granulator
- Suppository hardness tester and disintegrator
- Liquid pumps
Timeline
Formulation SCIENTIST
KVK Tech Inc
06.2022 - Current
Senior Formulation SCIENTIST
Torrent Pharma
07.2021 - 05.2022
Formulation SCIENTIST
KVK Tech Inc
08.2016 - 05.2021
Coding ANALYST
ADVANTMED LTD
06.2013 - 09.2015
BACHELOR OF SCIENCE - PHARMACEUTICAL SCIENCES
M.P.Patel College of Pharmacy
ORAQ Regulatory Affairs Training Program
Duke University School of Medicine
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