Rituja Ghotekar

Product Engineer

India7 yrs 6 mos experience
Highly Stable

Key Highlights

  • Over 7 years of experience in drug formulation development.
  • Led 25+ projects in pharmaceutical research and development.
  • Expert in optimizing analytical methods for drug formulations.
Stackforce AI infers this person is a Pharmaceutical Research and Development expert with a focus on analytical methods and drug formulation.

Contact

Skills

Core Skills

Analytical Research & DevelopmentDrug DevelopmentQuality AssuranceFormulation

Other Skills

Analytical method developmentHPLCFlow-through cell dissolution testerRotating bottleRegulatory ComplianceCross-functional CommunicationRI detectorTemperature optimizationDissolution studiesTraining programsSoftware updatesQuality ControlAnalytical TechniquesDocumentationFormulation processes

About

Hello! and thank you for stopping by. I am an opportunity seeker propelled by unwavering quest and who believes that -"Curiosity fuels imagination, driving exploration that sparks up innovative thinking". A Formulation ADL Specialist with a varied background in Research and Development. As a Senior Executive in Integrated Product Development, R&D Formulations at Cipla, I utilized my inquisitiveness to develope and analyse methods for various drug formulations and markets.I have over 7 years of experience and have served over 25+ projects, rendering various responsibilities ultimately accelerating the pace of drug development. * My background includes a broad experience in diverse projects, spanning - Novel drug delivery systems (NDDS) - Antiretroviral drugs - Anticancer medications - Ophthalmic products - Vitamins - Vaccines - Respiratory products For the US, Europe, and Indian market. as per GLP, GMP & Pharmacopeial standards * Effectively deployed strategies for refining analytical methods, analyzed degradation products, related substances, identification of impurities, extractable and leachable studies for drug formulation for FDA filing. Conducted studies as per ICH guidelines and in-house protocols. * I've authored URS documents for the instruments and equipment in compliance with U.S Tittle 21CFR and EU regulations * Method development using flow through cell and rotating bottle. Performed studies like purity, photostablity and impurities using HPLC * Revamped ELN software along with engineering team by troubleshooting errors facilitating an increase in speed of output by 30% * Identified major flaw in swab analysis reports to optimise MACO calculations.Enhanced cleaning validation, resulting in 10% increase in productivity and quality at the plant by minimizing residue cross-contamination at Goa plant. * Collaborated and communicated with third party engineers to uphold and update over 100+ instruments, organised annual in-house/scheduled precision tuning visits for over 200+ instruments. * I was a part of the budget team where I created comprehensive budget reports for the ADL department considering expenses, and financial goals.Resulted in enhanced 10x budgetary decisions. Excited to seek opportunities to dive more in the Pharma world.Eager to leverage my expertise for impactful contributions to dynamic R&D initiatives. My goal is to contribute to the innovation and to enhance health and well-being of people around the world. If you wish to connect you can shoot an email at : ritughotekar31@gmail.com

Experience

7 yrs 6 mos
Total Experience
2 yrs 6 mos
Average Tenure
--
Current Experience

Glg

Expert Network Member

May 2024Present · 2 yrs 1 mo · New York, United States · Remote

Cipla

Senior Executive- Integrated Product Development, R&D Formulations

Jan 2016Feb 2022 · 6 yrs 1 mo · Vikhroli, Mumbai

  • My role was responsible for the following initiatives :
  • 1.Developed an analytical method for a cytotoxic drug using an RI (refractive index) detector, optimizing temperature parameters for accurate and reliable measurements under the supervision of Dr. Bhanupratap Bind.
  • 2.Executed dissolution utilizing the flow-through cell apparatus tester.
  • 3.Utilized Rotating bottle apparatus (USP) for Liposomes to calculate encapsulation efficiency.
  • 4.Demonstrated proficiency in operating instruments like:
  • HPLC
  • RI
  • Flow-through cell dissolution tester
  • Rotating bottle
  • NGI
  • KF
  • Densitometer
  • Ubbelohde type viscometer
  • 5.Enhanced testing accuracy, by performing calibration resulting in 20% reduction in error rates in daily output.
  • 6.Implemented comprehensive training programs for Instrument software updates leading to a 10% increase in team proficiency.
  • 7.Created URS documents for procuring tailored instruments for research. Followed by meetings and trainings for below listed instruments which helped in precise data collection and contributed to more targeted and effective research outcomes :
  • ELSD3300
  • Ion Chromatograph VWD Detector
  • Breath Simulator BRS 2100
  • Liquid Chromatograph-Mass Spectroscopy (LCMS)
  • Ultra Performance Liquid Chromatography
  • Particle Size Analyzer with Zeta Seizer
  • Gentle Rocker
  • Fogger
  • Super Capacity Pump
  • Photo Stability Chamber
  • Refractive Index Detector
  • Dissolution Tester with UV Optical Fibers
  • Melt Flow Index Tester for polymers
  • 8.Single-handedly managed third-party research documents for the entire ADL department for SaiTech (- a GMP certified company).
  • 9.Generated documents in preparation for an faninacial audit.
  • 10.Conducted meetings for quality requirements with the coordination of cross functional team managers for software updation as per US Tittle 21CFR. Which Improved efficiency and Fidelity. Impacting by 2x reduction time to deliver result to the formulation team.
Analytical method developmentHPLCFlow-through cell dissolution testerRotating bottleQuality AssuranceRegulatory Compliance+3

Synergia life sciences

Research Analyst

Aug 2015Jan 2016 · 5 mos · Mumbai, Maharashtra, India

  • Designed and optimized HPLC protocols to precisely analyzed concentrations, ensuring accurate results.
  • Synchronized rigorous tests to establish the reliability and reproducibility of the developed analytical methods.
  • Contributed with teams to integrate state-of-the-art techniques in HPLC for enhanced analysis.
  • Exhibited proficiency in calibration of instruments to maintain optimal performance.
  • Contributed to the documentation, ensuring compliance with industry standards and regulatory requirements.
  • Implemented robust quality control measures to guarantee the accuracy and precision of analysis.
  • Executed advancements in analytical techniques, incorporating innovative approaches to improve methods.
  • Coordinated with team to support the formulation and quality control of drug
  • Presented findings and updates on analytical methods and its reports
HPLCQuality ControlAnalytical TechniquesDocumentationAnalytical Research & Development

Haffkine bio-pharmaceutical corporation ltd.

Research Assistant

Jan 2014Jan 2015 · 1 yr · Parel, Maharashtra, India

  • Initiated my professional voyage at this organisation and my key role included:
  • Fronted formulation processes for liquid syrups. Conducted pH test on every day bases
  • Conducted stability studies as per ICH guidelines and inhouse protocols.
  • Enacted lead acetate tests and endotoxin test studies for the safety and efficacy of packaging.
  • Assisted in the documentation of Potency test using Immunofluorescence Microscope which helped to study labeled antigens/ antibodies with fluorescent dyes for study of quantitative data on cell populations.
  • Performed surface monitoring test for vaccines. By choosing locations strategically by using an air suction pump to draw a volume of air through the device.That captured airborne particles to avoid contamination.
  • Trailblazed sterilization studies, enhancing overall safety and efficacy of manufacturing process.
  • Resolved issue related to the viscosity of glucose with HOD of Liquid medicament department.
  • Previously it used to take 1 day to pour it from the tank which affected productivity.
  • Initially we tried temperature induction furnaces, tilting the tank at a particular angle and various other methods to reduce time.
  • Further we tried using the Barrel unloading pump which successfully resolved issue resulting in unloading glucose in a few hours streamlining 30% better output.
  • Additionally, I've developed fishbone analysis studies to address batch failure issues promptly under the guidance of Dr. Sharon Reuben-Borkar is a seasoned scientist.
  • Collaborated closely with her where I gained valuable experience in problem-solving methodologies like Brainstorming and 5 Whys.
  • The 5 Whys technique employed to dig deeper into each cause.Understanding the underlying issues which aided better decision making by addressing the root cause.
  • Further developing effective solutions for each identified cause which facilitated for the development of effective corrective actions.
Formulation processesStability studiesDocumentationSterilization studiesFormulation

Blue cross laboratories ltd.

Internship Trainee

May 2012Jun 2012 · 1 mo · Nashik, Maharashtra, India

  • Mastered the operation of homogenizers, with precision and expertise in product consistency.
  • Expertly utilized microfluidizer, practicing in advanced fluid processing.
  • Operated capsule fillers, ensuring precise and efficient dosage delivery.
  • Perfected the art of tablet coating, adding a layer of finesse to pharmaceutical manufacturing.
  • Learned proficiency in handling particle sizers, contributing to accurate particle analysis.
  • Trained on High-Performance Liquid Chromatography (HPLC),ensuring accurate analysis.
  • Assimilated friability tests contributing to the assessment of tablet durability.
  • Carried out water analysis ensuring compliance with quality standards. Trained on tablet presses
  • Hands on training on centrifuge operation, contributing to efficient separation processes.
  • Utilized zetasizers with precision, demonstrating proficiency in nanoparticle analysis and characterization.
HomogenizersMicrofluidizerTablet coatingHPLC

Indi pharma pvt ltd

Student Trainee

May 2011May 2011 · 0 mo · Goa, India

Education

Shreemati Nathibai Damodar Thackersey Women's University

B.pharmacy — Medicine

Jan 2009Jan 2013

Gokhale Education Societys RNC Arts JDB commerce & NSC science

Higher secondary certificate — Science

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