摘要
About the Role
Major accountabilities:
Chemical, Biochemical and/or Biotechnological Expertise
- Biotechnological Processes: Strong understanding of fermentation and cell cultivation techniques.
- Purification Techniques: Skilled in filtration and chromatography methods.
- Biochemical Processes: Basic knowledge of biochemical principles.
- Risk Assessments: Experience in preparing Nitrosamine assessments, raw material risk evaluations, and declarations for residual solvents and elemental impurities.
- Physio-Chemical Properties: Good understanding of chemical and buffer properties (e.g., buffer capacity, stability).
- Analytical Methods: Familiar with basic techniques such as pH, conductivity, and density measurements.
Essential Requirements:
Technical Expertise
- Strong understanding of biotechnological processes (e.g., fermentation, cell cultivation techniques).
- Skilled in purification techniques (e.g., filtration, chromatography).
- Basic knowledge of biochemical processes.
- Experience in Nitrosamine preparation, raw material risk assessments, and declarations for residual solvents and elemental impurities.
- Good understanding of physio-chemical properties of chemicals and buffers (e.g., buffer capacity, stability).
- Familiar with basic analytical methods (e.g., pH, conductivity, density).
Manufacturing Excellence
Desired to be familiar with Manufacturing Process Transfer.Contribute to process improvement and optimization for product transfers.
Change Control
- Strong understanding of global and local change control processes; able to advise on strategy.
- Align cross-functional teams, including Regulatory, on change control plans and site impact.
- Prepare and present change request plans for endorsement at the Change Review Board (CRB).
- Open and manage change requests, assign impact assessments, and oversee lifecycle of CRs.
- Track and report implementation status with cross-functional teams.
- Maintain accurate documentation, version control, and compliance with cGMP and regulatory standards.
Training
- Contribute to process improvement and optimization for product transfers.
- Ideal Background / Requirements
- Education: Bachelor’s in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent; MSc/MS preferred.
- Experience: Minimum 8 years in MS&T (process validation) or large molecule drug substance manufacturing.
- Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
- Proven project management experience in cross-functional, multi-site environments.
- Expertise in reviewing and writing technical reports.
- Strong communication, presentation, and interpersonal skills.
- Proficient in English (oral and written).
- Desirable Requirements:
- Quality / Accuracy / Right First Time
- Timeliness
- Deviations / Escalations
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
