MS&T Technical Manager

Novartis India; Mumbai; On-site; INR 2,000,000 - 4,000,000; Full time

Job summary

Novartis India is seeking a Manufacturing Science & Technology leader to oversee end-to-end technology transfer and product launches with CMOs, ensuring processes, analytical methods and validations are delivered on time and to specification. You will lead cross-functional teams and manage milestones, budgets and regulatory readiness.

You will provide MS&T expertise to resolve deviations and CAPAs, maintain products in a validated state through CPV and continuous improvement, and collaborate

Qualifications

• MSc Degree in Organic Chemistry or related field.
• Proven experience in technology transfer, process validation, and product lifecycle management.
• Strong knowledge of cGMP, regulatory requirements, and change control.
• Experience working with CMOs and global cross-functional teams.

Responsibilities

• Lead end-to-end technology transfer and product launch activities with external manufacturing partners.
• Manage cross-functional technical projects, driving timelines, milestones, quality, budget, and stakeholder alignment throughout the product lifecycle.
• Support CMO selection and assess technical capabilities to ensure the right manufacturing fit for product transfers and commercial supply.
• Define, execute, and document transfer, validation, and process verification strategies, including transfer protocols, reports, regulatory, feasibility, and validation batches.
• Provide manufacturing science and technology expertise to resolve deviations, investigations, OOS/OOE events, technical complaints, and complex manufacturing challenges.
• Maintain products in a validated state through ongoing process monitoring, Continued Process Verification (CPV), annual reviews, and data-driven performance trending.
• Assess the impact of manufacturing changes and ensure appropriate technical risk management, validation, and regulatory compliance.
• Lead technical CAPA definition, implementation, and effectiveness tracking arising from deviations, APR/PQR reviews, and process performance assessments.
• Drive process optimization, continuous improvement, remediation activities, and operational excellence initiatives to enhance product quality and manufacturing robustness.

Skills

Technology transfer

Cross-functional teamwork

Project management

cGMP knowledge

Regulatory compliance

Technical documentation

Education

MSc Degree in Organic Chemistry

Job description

Summary

Lead and manage all Manufacturing Science & Technology activities for the assigned Contract Manufacturing Organizations (CMOs). This includes providing product stewardship by ensuring the performance of all NVS products are monitored and maintained in a validated state, supporting root cause investigations by providing MS&T intelligence to deviations, technical complaints, OOS & CAPAs, identifying and executing continuous improvement

Lead and manage all Manufacturing Science & Technology activities for the assigned Contract Manufacturing Organizations (CMOs). This includes providing product stewardship by ensuring the performance of all NVS products are monitored and maintained in a validated state, supporting root cause investigations by providing MS&T intelligence to deviations, technical complaints, OOS & CAPAs, identifying and executing continuous improvement opportunities. Acts as the ESO Project Team Lead (PTL) for new product launch at CMO’s / technology transfer at CMO’s. Assembles and leads a cross-functional team to ensure the successful transfers of manufacturing at CMOs. Ensures appropriate project management to achieve milestones in time, with required quality and in budget by leading the respective technical sub-team and liaising efficiently with related functions.Supports the MS&T organization by leading ESO-wide initiatives and/or work-streams and representing ESO MS&T in various global networks.

About The Role

Major accountabilities:

• Lead end-to-end technology transfer and product launch activities with external manufacturing partners, ensuring successful execution of process, technology, analytical, and validation deliverables.


• Manage cross-functional technical projects, driving timelines, milestones, quality, budget, and stakeholder alignment throughout the product lifecycle.


• Support CMO selection and assess technical capabilities to ensure the right manufacturing fit for product transfers and commercial supply.


• Define, execute, and document transfer, validation, and process verification strategies, including transfer protocols, reports, regulatory, feasibility, and validation batches.


• Provide manufacturing science and technology expertise to resolve deviations, investigations, OOS/OOE events, technical complaints, and complex manufacturing challenges.


• Maintain products in a validated state through ongoing process monitoring, Continued Process Verification (CPV), annual reviews, and data-driven performance trending.


• Assess the impact of manufacturing changes and ensure appropriate technical risk management, validation, and regulatory compliance.


• Lead technical CAPA definition, implementation, and effectiveness tracking arising from deviations, APR/PQR reviews, and process performance assessments.


• Drive process optimization, continuous improvement, remediation activities, and operational excellence initiatives to enhance product quality and manufacturing robustness.


• Ensure compliance with cGMP, HSE, quality, and regulatory requirements while maintaining technical knowledge and process expertise throughout the commercial product lifecycle.

Essential Requirements

• MSc Degree in Organic Chemistry or any other Chemistry related degree.


• Proven solid experience in technology transfer, process validation, product lifecycle management, and technical support within pharmaceutical manufacturing.


• Strong knowledge of cGMP, regulatory requirements, quality systems, deviations, CAPAs, change control, and process validation.


• Experience working with external manufacturing organizations (CMOs) and leading cross-functional collaborations in a global environment.


• Excellent communication, stakeholder management, negotiation, and technical documentation skills, with the ability to influence and collaborate across multiple functions.

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 [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB)