Amarnath Reddy Ganji
Formulation Dev | GH&B | | MSAT | | LSSYB | Injectable/ Long Acting Injections / Oral Solids | Tech Transfer | Life Cycle Management | Quality Culture | DAI | Leadership LandIt |
- Role
- Manager at 화이자
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Amarnath Reddy Ganji
Specializing in formulation development, analytical research, and technology transfer, I bring proven expertise in driving successful product launches within the pharmaceutical industry. Recognized as a subject matter expert in developing injectables, long-acting injections, and solid oral formulations, I am committed to advancing innovative drug delivery solutions and ensuring excellence in pharmaceutical processes.
Experience
Manager
Mar 2022 — Present · IN
Engaged in working with cross-functional development teams globally (US, UK, China and India) and design/development experiments to help identify formulations and processes key to advancement of pipeline with integrated Quality by Design (QbD) approach focusing on development of formulation and process, with emphasis on reliability and consistency.Provides technical relationship oversight for the CMO sites, coordinating GTE resources as needed to resolve technical issues raised to the VSOT, ensure GTE resource assignments for source change projects and complex investigations and ensure IMEX escalation pathways are maintained, and metric data flow is timely and consistent. Leading technical investigations and process improvements at CMOs, using Six Sigma Tools when required,Partners with other functional areas to achieve success against business goals and objectives: Global External Supply, External Supply Quality, Procurement, Supply Chain, Planning, Finance, EHS, Regulatory, Business, Commercial.Seeks, develops and implements improvements to GTE work processes, where appropriate.Undertake high quality scientific experimentation to further the reformulation/remediation and process development of dosage forms which may include formulation design, process to derive appropriate data and decision making (initial focus on Nitrosamine remediation).Preparation and reviewing of Strategy documents, technical documents, including Product Development reports, Formulation development plans/reports, QbD protocols/reports, Co-Development plans, general technical reports, and applicable CTD sections for global submissions.Presents information at key forums for the business unit, both internally (i.e. technical reviews) and external (i.e. governance meetings).Provides technical leadership and communicates clearly and concisely across multiple scientific and business functions, building effective relations with internal and external customers.
Education
Rajiv Gandhi University of Health Sciences
Master of Pharmacy (M. Pharmacy)
Acharya Nagarjuna Vishwavidhyalayamu
Bachelor of Pharmacy (B. Pharmacy)
National Academy of Legal Studies & Research (NALSAR) University Hyderabad
Intellectual Property Rights
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