Eso Analytical Science Technology Manager Chemical Active Ingredient Job In The Medicines Company In Mumbai, India

Job DescriptionJob Description 28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently Your key responsibilities:Your responsibilities include, but not limited to: Lead, implement and reports on global AS&T requirements/programs in the assigned ESO QA Network Supports defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply (eg.

, data integrity, analytical change management) Escalates any analytical issues or instances of instability per the Novartis escalation policy, initiates any market action as required Owns and maintains testing monographs for products in scope of ESO Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation This includes, but not only, reviewing registration documents and being in line with pharmacopeia standards.

Supports the accountable QAM to define and maintain the ESO Stability Program at CMOs, ensures that Stability Programs are state-of-the-art with respect to HA requirements and in line with registration documentation Leads programs and initiatives to implement changes and remediation as required Interprets stability data, analyzes trends, and provides scientifically sound conclusions for product shelf life/re-test assessments, storage conditions and packaging and transport categories.

Defines corrective actions to address immerging stability issues together with MS&T Supports and drives analytical trouble shooting Owns and/or ensures analytical investigations are managed in agreement with cGxP standards and the right CAPAs are implemented Acts as SPOC for analytical subjects in cross functional ESO AS&T project teams.

Owns tech transfer assessments for analytical method transfers or new analytical methods Owns changes regarding analytics and/or provides the required assessments in regard to analytics during general change control activities Defines studies/assessments needed to support changes regarding analytics Supports implementation of guidelines at the assigned external partners and suppliers.

Provides the analytical input required for External Suppliers Qualification process Supports site readiness for Health Authority inspections & participate in audits on requestDiversity & Inclusion / EEO Minimum Requirements What you'll bring to the role: Minimum 13 years' experience in the API - Quality Control in the pharmaceutical industry Min.

5 years experiences in Quality Control, method development, method validation or stability testing Expertise in Lab Investigation and OOS investigation Thorough knowledge of cGMP requirements.

Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management Good indirect leadership skills Good project management skillsDesirable: Higher university degree M.

Sc or PhD in Chemistry, Biochemistry, or another related scienceWhy Novartis766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's livesWe believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

That a diverse, equitable and inclusive environment inspires new ways of working We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis!Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information.

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The Medicines Company is looking for Any Graduate / Post Graduate profile candidates.