Resumen
About the Role
Major accountabilities:
Your responsibilities include but are not limited to:
• Leading all analytical tasks of complex projects incl. planning resource & budget and authoring respective analytical documents.
• Selecting testing laboratories in line with resource availability, capability and in/outsourcing strategy; these include the laboratories of Novartis Global Device & Packaging Development (GDPD), as well as Novartis TechOps Quality Control and external Contract Research Organisations (CROs).
• Leading outsourced analytical project activities at CROs and contributing to the management of external partnerships.
• Taking ownership of drug-specific analytical methods (AMs) / parameter sheets (PSs) and organising and aligning x-functional inputs (e.g. with Device/Pack Tech).
• Defining, organising and documenting AM/PS validation and transfer.
• Co-shaping and co-authoring x-functional analytical CMC strategies and documents; This will include drug product and final product stability strategy, protocols and reports, method validation and transfer status summaries and Analytical Specifications (AS).
• Organizing and aligning input to Justification of Specification (JoS) from Device/PackTech and Human Factors Engineering (HFE)
• Leading x-functional overarching initiatives; mentoring (senior) experts
• Contributing to and reviewing regulatory documents, supporting product registrations and presenting at inspections.
Minimum Requirements:
• Master or PhD in engineering or functional/chemical/bio analytics or equivalent and minimum 10 years’ experience in pharmaceutical industry, including drug-device combination product development
• Profound knowledge in analytical tasks including functional (physical) testing of late phase parenteral drug delivery devices or combination products
• Leadership experience in managing development projects, ideally in a global matrix environment.
• Understanding and awareness of regulatory guidelines for combination product analytics.
• Experience with current good manufacturing practice (cGMP) and relevant ISOs.
• Collaborative spirit, self-driven attitude, high level of learning agility
• Fluent in English (oral and writing)
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
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. Level 5: In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 89,600.00/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
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
Adjustments for Applicants with Disabilities
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
