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Mumbai, Maharashtra, India
Hybrid
Band
Level 4
Job Description Summary
#LI-Hybrid
Job Description
Key Responsibilities
Lead technology transfers of Oral Solid Dosage (OSD) products to Contract Manufacturing Organizations (CMOs).
Assess manufacturing capabilities, identify technical gaps, and support CMOs in achieving transfer readiness.
Drive manufacturing and packaging validation activities, ensuring protocols, timelines, and acceptance criteria are met.
Monitor validation batches at manufacturing sites and provide hands-on technical support during execution.
Review manufacturing, validation, and stability data to ensure product quality and compliance requirements are met.
Investigate technical issues and support the implementation of effective solutions during transfer and validation activities.
Collaborate closely with Supplier Relationship Teams, Lifecycle Managers, Quality, and external manufacturing partners.
Manage multiple product transfers and validation projects simultaneously, ensuring timely delivery of project milestones.
Provide regular project updates, risk assessments, and technical recommendations to key stakeholders.
Act as the technical expert for OSD manufacturing processes across assigned external manufacturing partners.
Essential Requirements
Master's degree or post-graduation in Pharmacy.
Minimum 10 years of experience in pharmaceutical manufacturing, with minumum 7 years in Technology Transfer, Manufacturing Science & Technology, or Technical Operations.
Strong experience with Oral Solid Dosage (OSD) products, including tablet manufacturing processes.
Proven experience leading technology transfers to Contract Manufacturing Organizations (CMOs).
Hands-on experience with manufacturing and packaging validation activities, including protocol development, execution oversight, and validation review.
Strong understanding of GMP, pharmaceutical quality systems, and regulatory requirements.
Ability to independently drive multiple tech transfer and validation projects and effectively manage technical stakeholders.
Excellent knowledge of English and proficient in the local language.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
Accessibility and Accommodation
Novartis 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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Applied Statistics, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer