Summary
About the Role
Major accountabilities:
Your responsibilities will include, but are not limited to:
- Work with third-party partners to oversee microbiology activities, including data review, capability development, SOP review and development, and handling deviations. Collaborate with external labs to ensure compliance with contamination control strategies, cleanroom classification, and aseptic risk assessments. Provide subject matter expertise and guidance for the microbiological tests performed at third parties
- Advance adoption of ARD digital solutions; monitor method lifecycle metrics and lead simplification/automation projects.
- External Partner & Cross-Functional Collaboration: Serve as ARD technical point of contact for CDMOs/external labs—define method readiness, training, transfers, and quality expectations; review packages and resolve technical gaps
- Design, plan and interpret scientific experiments for projects at different clinical phases of drug substance and drug product development with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.
- Write, review and/or approve analytical documentation in timely and high-quality manner, such as releases, analytical batch records, method validations, stability, technical reports, SOP’s etc. ensuring compliance with Novartis and health authorities' guidelines
- Manage interactions and contribute to a high level of collaboration with internal and external stakeholders like QA & Technical operations
- Adhere to Quality metrics, Compliance and Good Documentation Practices following ALCOA+ principles, GLP, OQM, HSE, ISEC and Novartis guidelines.
- Should be a Team player by adding value in collaborating with other teams to support project deliverables within agreed timelines, mentoring new joiners, active participation in project meetings / networks and contributing to team goals while meeting individual objectives.
Role Requirements
- MSc/PhD in Analytical Chemistry, Pharmaceutical Sciences, Microbiology, or related field with minimum 6 years’ experience or M. Pharma/M. Sc with a minimum of 12 years’ experience in the pharmaceutical industry in analytical research and development
- At least 6-12 years of experience in GxP labs (ARD/QC) with proven leadership in analytical method development/validation/Method transfers and microbiology testing
- Analytical rigor & scientific judgement; Microbiology SME with risk-based mindset.
- Good presentation and scientific/technical writing skills.
- Good communication skills.
Key performance indicators:
- Adherence to costs, quality, quantity, and timelines for all assigned tasks.
- Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
- Feedback from other team leaders and advisory boards.
- Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented.
- Internal and external publications/presentations, invited lectures.
Skills:
- Coaching Skills.
- Data Science.
- Environment.
- Experiments Design.
- Health And Safety (Ehs).
- Laboratory Equipment.
- Manufacturing Process.
- Project Management.
- Sop (Standard Operating Procedure).
- Technical Writing.
Languages :
- English.
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: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
