ANANTH SUBBAIAH PARTHIBAN
Bellach
Summary
Determined and well-rounded individual with more than 13 years working as Analytical Scientist within Pharmaceutical industry. Sharp and focused professional offering skills in Analytical project management , CDMO management , Method Validation , Method Transfer , Stability and Regulatory Documentation.
Overview
13
13
years of professional experience
Work History
Scientist I
Biogen S.A
01.2020 - Current
- Leading and managing analytical activity such as validation and transfer of in-process, release, and stability test methods for the clinical and commercial campaign to and from internal/external QC groups and with CLOs
- Responsible person for regulatory intelligence assessment.
Senior Scientist
Debiopharm International Ltd
01.2020 - 12.2020
- Leading and managing analytical activities for projects (Phase I and II) with CDMOs in terms of setting up Timelines, Budgets, Specification Strategies, Method Development, Method Validation, Stability, Release Testing, Approving Analytical Documents like protocols and Reports from CDMOs,and CMC documentation for Regulatory Submission.
- Part of the outsourcing team to find new CDMOs for projects and lead CDMOs' performance evaluation tool (Dashboard) to monitor their performance.
Stability and Analytical Senior Scientist
Nestle Skin Health
01.2019 - 12.2019
- Lead person for Analytical testing plans and stability programs for internal and external activities.This includes review and evaluation of analytical data, protocols, reports, and supporting regulatory documentation.
- Maintenance of stability information, including preparing and maintaining written stability protocol, stability database, trend analysis, and interpretation of results.
R&D Analytical Associate
Reckitt Benckiser Hull
05.2016 - 12.2018
- Lead analytical projects in-house and externally in the development of New products (NPDs) within the digestive relief team, This involves budget, resource, and timeline planning for all analytical activities within team.
- Performed Method validation, and Stability studies in compliance with ICH guidelines and dossier writing CTA and CTD for new products within a team in compliance with the ICH guidelines and MHRA requirements.
- Monitoring and testing ongoing stability samples and performing trend analysis for stability results throughout the study
- Experience in writing analytical validation and stability protocols and reports
- Working in collaboration with cross-functional teams such as marketing, regulatory, Quality, supply (production), formulation and medical teams and efficiently delivering projects within agreed timelines.
Tillomed Laboratories Ltd
06.2010 - 05.2016
Quality Control Team Leader (Release)
03.2014 - 05.2016
- Planning, preparing, and managing contingency plans for daily tasks for testing raw materials, bulk drug products, and finished products.Work with the team to achieve task data analysis, data generation, report writing, and report preparation
- Support with risk assessment for handling chemicals and pharmaceutical products; training analysts on safe working practices.
- Involvement in quality issue investigations and implementation of CAPA, and Weekly update of quality reports to QA team such as OOS/CAPA/Deviation.
Senior Quality Control Analyst
09.2013 - 02.2014
- Performed method validation and method transfer for new product introduction, and supported ongoing stability testing.
- Review and maintenance of laboratory reference standards, and implemented e-log for reagents.
Quality Control Analyst
01.2011 - 08.2013
- Testing of the finished product, raw materials, and stability samples using a variety of analytical techniques; HPLC, UV spectroscopy, FTIR, Dissolution, Karl Fischer Titration
- HPLC troubleshooting and Handling HPLC Software Totalchrom, Chemstation,
- Calibrating and maintaining laboratory equipment such as HPLC, UV, IR, PH meter, and dissolution apparatus to ensure compliance with cGMP, GLP and Sop’s.
Quality Control technician
06.2010 - 12.2010
- Performing routine analysis and physical testing (Disintegration, Friability, IR, Hardness Tester, TLC)
- Management of samples (Receipt, allocating sample reference number, preparing summary sheet, test to be carried out according to properly validated method and release date) and Maintaining lab stock- all chemical list expiry, Review date, etc
Education
MSc - Pharmaceutical sciences
University of Greenwich
2009
B.Tech - Pharmaceutical Engg & Tech
Bharathidasan University
2007
Skills
- Experience in Analytical Project management
- Experience in method validation, method transfer and handling OOS/Deviation/CAPA
- Experience in stability studies, stability trend analysis and completing stability report in compliance with ICH guidelines
- General IT skills (MS word, MS excel, MS project and PowerPoint)
- Experience in office tools like Technical document system, Track wise,Mycims Ennov, eroom and Documentum
Accomplishments
- Analytical method development and validation for Aspirin and Paracetamol combination drug using HPLC (4 months).
Timeline
Scientist I
Biogen S.A
01.2020 - Current
Senior Scientist
Debiopharm International Ltd
01.2020 - 12.2020
Stability and Analytical Senior Scientist
Nestle Skin Health
01.2019 - 12.2019
R&D Analytical Associate
Reckitt Benckiser Hull
05.2016 - 12.2018
Quality Control Team Leader (Release)
03.2014 - 05.2016
Senior Quality Control Analyst
09.2013 - 02.2014
Quality Control Analyst
01.2011 - 08.2013
Tillomed Laboratories Ltd
06.2010 - 05.2016
Quality Control technician
06.2010 - 12.2010
MSc - Pharmaceutical sciences
University of Greenwich
B.Tech - Pharmaceutical Engg & Tech
Bharathidasan University
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