Summary
As part of the Drug Product Development Scientific Office you should provide strategic and technical guidance on product design and development in liaison When you are a part of the Development team, you'll have countless opportunities to develop your career, as you'll be surrounded by people you can learn from and help you reach your full potential.
Our team is seeking a Drug Development Technologies Strategy Lead.
As part of the Drug Product Development Scientific Office you will provide strategic and technical guidance on product design and development in liaison with key stakeholders in CMC, drive engagement with industry consortia and health authorities to enable new technologies implementation, and propose and drive solutions to development challenges.
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This role is based in Basel, Switzerland.
About the Role
Your responsibilities include, but are not limited to:
- Champion holistic understanding of patient- and payer focused drug development and incorporate new technologies (pharmaceutical / in-silico) in conjunction with Health Authorities expectations.
- Engage in industry consortia to shape regulatory environment and influence key opinion leaders.
- Liaise with key stakeholders, including Biomedical Research, Global Program Teams, Devices and Primary Packaging, Regulatory CMC, Quality, and Commercial Manufacturing sites, to integrate Drug Product requirements with their needs for a patient-centric product.
- Provide strategic and technical guidance on Drug Product Design and product development strategy
- Support / drive interactions with health authorities through participation on briefing packages
- Proactively identify, lead/propose solution oriented plans to resolve drug product development challenges/barriers.
- Lead scientific programs and act as member of advisory boards for scientific issues
Minimum requirements
- 10+ years experience in the biopharmaceutical industry with a Scientific qualification.
- Prior experience in project leadership or people management paired with the ability to engage cross-functional teams
- Experience of cross-functional collaboration and leading within a matrix?
- Experience in Drug Product manufacturing of sterile dosage forms including frozen, liquid, and lyophilized formulations in vials and pre-filled syringes
- Experience in Biologics development, and specifically DP process development, understanding of drug product manufacturing process operations such as mixing, sterile filtration, and aseptic fill/finish.
- Relevant experience of developing and implementing strategies of patient-centered science related work
- Analytical thinking to anticipate impact and consequences
- Experience in writing regulatory modules including INDs and BLAs
- Knowledge of regulatory guidance from the FDA and EMA for development of biologic drug products
- Knowledge of USP and Ph. Eur. as it relates to biologics development
- Learning agility towards new delivery technologies
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.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
Division
Development
Business Unit
Innovative Medicines
Location
Switzerland
Site
Basel (City)
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No