Drug Substance Project Leader (m/f/d)
- Kufstein, Austria
Senior Gene Therapy Expert / Drug Substance Leader (m/f/d), Global Drug Development, Kundl, Austria
More than 500! That is the number of clinical trials ongoing worldwide for CAR-T cell therapies. We are looking for a senior Drug Substance Project Leader, to develop and drive technologies in the field of Cell and Gene Therapies. The successful candidate will be accountable for general and strategic Downstream process (DSP) aspects in this area with special focus on Lentiviral Vectors. The role comprises the scientific leadership as the DSP process specialist in the project team as well as facilitation and tracking of major process development and manufacturing activities to ensure timely and consistent process development for Cell and Gene Therapy projects.
Within the CGT field, the candidate will build and establish expertise in Lentiviral Vector process development and manufacturing with focus on downstream technologies.
Your responsibilities include, but are not limited to:
• Down Stream Process (DSP) process and technology strategy for Cell and Gene Therapy projects in early phase development, with focus on Lentiviral Vector based Cell and Gene Therapies
• Single point of contact for Technical Project Leaders and other partners for key DSP process aspects
• Planning and tracking of major DS process development and manufacturing activities and results in collaboration with the Line Function
• Represent the DS sub-team as core member in the technical CMC project team
• 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).
What you'll bring to the role:
• M.Sc. or Ph.D. in Biotechnology, Bioengineering or equivalent with 8 - 12 years of proven experience in downstream processing of Lentiviral Vectors and/or viruses 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
• Proven management and leadership skills with respect to planning/tracking, prioritization and project timelines
• Experience with CMO management and collaboration with external partners
• Sound written and oral communication skills and concise data presentation in English required
• Familiarity with GMP requirements
• Experience with downstream processes for diverse Biologics formats
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 € 62.146,14 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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