Gene Therapy / Drug Substance Director (m/f/d)
- Kufstein, Austria
Gene Therapy / Drug Substance Director (m/f/d), Global Drug Development, Kundl, Austria
More than 500! The clinical trials ongoing worldwide for CAR-T cell therapies. We are looking for a senior Drug Substance Project Leader in TD-NBE, to develop and drive technologies in the field of Cell and Gene Therapies. The candidate will be accountable for the technical and the strategic aspects of Upstream and Downstream process (USP & DSP) for the viral vectors with a special focus on Lentiviral Vectors. The role comprises the scientific leadership as the viral vector process scientific expert in the project team as well as coordinating the technical development and GMP manufacturing activities with internal and external partners, to ensure timely and consistent process development for Cell and Gene Therapy projects.
Your responsibilities include, but are not limited to:
• Act as Viral Vector senior expert within Cell & Gene Therapies Department
• As part of the leadership team, develop and support department strategy definition and execution.
• USP & DSP process and technology strategy for Cell and Gene Therapy projects, in line with portfolio needs and health authority requirements
• Single point of contact for Technical Project Leads and external and internal partners (e.g. Discovery, GMP manufacturing, Academia, ...)
• Lead DS process development and manufacturing activities to ensure high quality deliverables in collaboration with the Line Function
• Represent the DS subteam as core member in the technical CMC project team and Ad Hoc streering committees
• Coordinate and provide input to Reg-CMC on DS processes (e.g. in response to questions from regulatory authorities, Briefing Books, preparation of Health Authority meetings).
• Lead the new technologies assessment and provide recommendations on CAPEX.
• Act as the Subject Matter Experts (SME) for due diligence and external representations
What you'll bring to the role:
• M.Sc. or Ph.D. in Biotechnology, Bioengineering or equivalent with 10-15 years experience in upstream and downstream processing of Viral Vectors in an industrial environment
• Advanced knowledge in purification technologies in the field of Cell and Gene Therapy and experience in Biosafety regulations, BL-1 and BL-2
• Strong leadership skills
• Experience with CDMO and collaboration with external partners
• Familiarity with GMP requirements
• Experience with downstream processes for diverse Biologics formats is an advantage
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 68.368,72 per year on a full time basis)
Imagine what you could do at Novartis!
Novartis is an equal opportunities employer and welcome applications from all suitably qualified persons.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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