Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Publications
Professionalsoftwareproficiency
Certification
Timeline
Generic

Rajesh Vepuri

Pharmaceutical Research And Development
Chesterfield,NJ

Summary

Accomplished professional with 14 yrs. of experiences in Formulation Research and Development, Process designing, Process Optimization, Validation (Product and Engineering) CMO Operations & Technology Transfer, New Product Launches, Quality and Compliance, Investigations & RCI, Product Robustness, Project Management, MS&T & Routine commercial validation

Talented Manager with expert team leadership, planning, and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.

Overview

14
14
years of professional experience
1
1
Certification
3
3
Languages

Work History

Manager

MARLEX PHARMACEUTICALS INC.
New Castle, DE
03.2023 - Current
  • Product transfer between the internal/external sites, Facility & equipment mapping, material assessment, Scale-up calculations, Gap analysis, Process transfer & execution, Addressing the major quality notifications/incidences/OOS/OOT, address the major deficiencies, control strategy for exhibit/validation batches
  • Product improvements and COPE/COPQ reduction, Cycle time reductions
  • Data analysis using statistical techniques and digital tools
  • Investigation of CPV failures
  • Participate quality audits when required
  • Creation and implementation of SOPs as well as GLP/GMP guidelines and trainings
  • Review and filling annual reports
  • Review BMRs and BPRs
  • Review of Protocols (Compatibility study protocols, Sampling Protocols, Validation Protocols, Stability Protocols, and IQ, OQ & PQs and Summary reports)
  • Actively participate on various projects and committees such as operational excellence, site management, R&D product transfer
  • Handling, reporting, and investigating of all CAPA and ADEs
  • In charge of internal and external Audits & responses to any complaint documentation regarding of products approvals
  • Accomplished multiple tasks within established timeframes.
  • Improved marketing to attract new customers and promote business.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Developed and maintained relationships with customers and suppliers through account development.
  • Managed budgets effectively, ensuring optimal financial performance while investing in necessary resources for business growth.
  • Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.

Manager

APNAR PHARMA LLP
02.2022 - 03.2023
  • Formulation development trials planning with process scale up, and technology transfer of conventional and continuous processing technologies.
  • Data observation, record, review and compilation
  • Optimize formula and processes based on analytical results
  • Preparation Product Development Reports
  • Review of Pilot batch, exhibit batch and Validation/commercial batch BMRs (Batch Manufacturing Record)
  • Development Projects LNB online review
  • Review of Protocols (Compatibility study protocols, Sampling Protocols, Stability Protocols, Process validation Protocols and Equipment Qualification protocols).
  • Prepare batch calculations for scale up, exhibit and commercial batches for suitable equipment with scientific strategies with statistics tools.
  • plan scientific studies to execute scale up formulations.
  • Develop new and efficient processes for manufacture of current products to drive the cost competitiveness

Formulation Scientist – I (Lead)

Aurex Laboratories LLC
08.2018 - 01.2022
  • Perform technology transfer and assist in technology transfer operations utilizing SUPAC guidelines to develop, validate and commercialize products by assessing the original developer or manufacture' product information from the raw materials used, the facility, process, equipment’s and personnel; prepare documentation such as transfer protocols(Master Formula Card, Hold Time Study Protocol, Dissolution Profiling Protocols, Stability Study Protocols, Product Development Report, Master packing configuration, packaging evaluation report etc.,) development reports, master batch records, specification and manufacturing batch records
  • Planning Organize, design, and execute scientific experiments to support product development with cost effective process
  • Preparation and Review documents including formulation and product development protocols and reports.
  • Plan and perform bench top lab scale formulations and study various parameters to optimize the dosage form to obtain maximum safety, quality, and efficacy
  • Plan and Conduct pilot bio scale batch based on the success of the lab scale formulation
  • Verify the process to analyze the gaps with using PAT technologies.
  • review and approve CPV protocols, reports and present CPV data as needed to Subject Matter Experts (SMEs).
  • Support batch processing data collection and verification activities.
  • Plan and Conduct validation batches on the commercial level, to validate the equipment and its setting to validate the procedure and documentation
  • Work with technical services on process development to support commercial scale up as well as technology transfer.

Assistant Manager

Aurex Laboratories Private Limited
09.2015 - 07.2018
  • Literature search & Pre-formulation studies: Perform literature search of new projects
  • Innovator/Brand leader patent data, Clinical & Bio pharmaceutics data, SBOA data
  • Scale-up and Process optimization studies: Scale-up of formulations from lab scale to pilot/commercial scale, performing process optimization of formulations at lab scale as per QBD principles by identifying the CPP’s and CQA’s
  • Stability studies.
  • Preparation of various Technology Transfer Dossier Documents
  • Process development studies: Performing Scale-up studies of formulations at lab scale level and from lab scale to pilot level as per QBD principles (Evaluate relevant characteristics of raw materials in effort to identify CPPs and CQAs and develop robust products)
  • Interpretation of data and preparation of reports for lab scale batches and scale up batches
  • Technology transfer of E-batches: Work with technical research and development team to ensure a robust scale-up of new products
  • Lead optimization of pharmaceutical processes by applying sound scientific reasoning and following technology strategies
  • Ensure to taking caring of technical changes and related to technical issues

Assistant Manager

Optimus Pharma Private Ltd
06.2015 - 09.2015
  • Prototype development batches.
  • Formula optimization studies.
  • Scale-up and Process optimization studies.
  • Technology transfer.
  • Technical documents evaluation.

Senior Executive

MSN Laboratories Private Ltd
05.2011 - 06.2015
  • Literature search
  • Pre-formulation studies
  • Prototype development batches
  • Formula optimization studies
  • Scale-up and Process optimization studies (QbD)
  • Validations Batches
  • Technology transfer.
  • Continuous process verification.
  • Technical documents evaluation.
  • And PDR write up for developed products

Education

MBA -

Prof G. Ram Reddy Center For Distance Education, Osmania University
Hyderabad

Master of Science - Pharmaceutics

KVSR Siddhartha College of Pharmaceutical Sciences, Acharya Nagarjuna University
Vijayawada

Bachelor of Science - Pharmacy

Talla Padmavathi College of Pharmacy, Kakatiya University
Warangal

Skills

  • Formulation research & development

  • Material science and technology

Process design and Technology transfer

  • Scale-up and validation (process and Equipment)

  • Product improvements/simplifications

  • QbD elements and DoE ( FMEA, FTA, PAT)

  • Continued Process Verification (CPV) and Statistical evaluation of data

  • Control Strategy (risk assessment/risk Evaluation/risk reduction)

  • Root cause analysis

  • CAPA/Change controls/Deviations

  • Technical assessment review

GMP/ Quality/ Documentation and facility management

Regulatory Compliances&Life cycle management

Accomplishments

  • Developed Iron effervescent powder formulations
  • Developed Toothpaste tablets for Colgate Palmolive by using organic raw materials
  • Developed Mouthwash effervescent tablets for Colgate Palmolive by using organic raw materials
  • Successfully completed two molecules for pulmonary arterial hypertension for US market
  • Successfully completed Xanthine oxidase inhibitor tablets for US market
  • Developed P2Y12 platelet inhibitor (thienopyridine) Tablets for US market
  • Developed COMT inhibitor Tablets for US market
  • Developed Diuretic (monosulfamyl) Tablets for US market
  • Developed Anticholinergic Tablets for EU market
  • Developed NSAID (COX-2 inhibitor) capsules for US market
  • Developed NSAID soft gelatin capsules for OTC and Prescription projects
  • Successfully completed extended-release (ER) product and its combination with IR product for Type-2 diabetes as Bi-layered and mini tablets

Publications

  • Formulation and Evaluation of Controlled release Natural Biodegradable Ornidazole Dental Implants for Periodontitis, Graduation
  • Design And Evaluation of Bosentan Tablets For Pulmonary Arterial Hypertension, Master's degree
  • Design and Evaluation of Pantoprazole Sesquihydrate Delayed-Release Tablets for Gastroesophageal Reflux Disease – GRED (anti-ulcer), Master's degree

Professionalsoftwareproficiency

  • Trained and certified on Statistical and programming tools: Minitab
  • MS OFFICE
  • SAP
  • RF XCEL

Certification

Minitab

Timeline

Manager

MARLEX PHARMACEUTICALS INC.
03.2023 - Current

Manager

APNAR PHARMA LLP
02.2022 - 03.2023

Formulation Scientist – I (Lead)

Aurex Laboratories LLC
08.2018 - 01.2022

Assistant Manager

Aurex Laboratories Private Limited
09.2015 - 07.2018

Assistant Manager

Optimus Pharma Private Ltd
06.2015 - 09.2015

Senior Executive

MSN Laboratories Private Ltd
05.2011 - 06.2015

MBA -

Prof G. Ram Reddy Center For Distance Education, Osmania University

Master of Science - Pharmaceutics

KVSR Siddhartha College of Pharmaceutical Sciences, Acharya Nagarjuna University

Bachelor of Science - Pharmacy

Talla Padmavathi College of Pharmacy, Kakatiya University

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