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
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.
Job Description
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 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