Senior Technical Transfer Lead (f/m/d), Drug Substance Kundl, NTO, Austria
> 40 years of expertise in Biotech production and a growing product portfolio including protein, pDNA and mRNA molecule formats. Join the Manufacturing Science and Technology team in Drug Substance Kundl and participate at the frontline in pioneering the future of our Biologics
Your responsibilities include, but are not limited to:
•Provide technical leadership for transfer projects to our recombinant protein plants and nucleic acid facility (NAF) and liaise efficiently with involved functions (e.g. technical development, supply chain, QA, QC, HSE, other sites, etc.)
• Act as single point of contact (SPOC) on site for technical transfers: Lead and handle all activities for assigned projects on site level (process, technology, analytics, capacity, etc.)
• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines as well as HSE and corresponding GMP guidelines are met
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategy and timelines
• Conceive transfer strategy and provide input into overall project strategy and plans including timelines
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer
• Initiate local change control in system on site and ensure approval and closure
• Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report)
• Establish local procedures & templates for technical transfers and contribute to process improvements and optimization for product transfers
What you'll bring to the role:
• Education: University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering or equivalent degree
• Experience: Minimum 8 years of relevant professional experience in manufacturing / manufacturing science and technology / technical development / quality
• Proven understanding of biotechnology processes (Up- and Downstream) and experience in executing process transfers
• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines
• Proven track record in leading interdisciplinary teams and project management skills
• Excellent communication skills
• Languages: Proficient in English and German
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 EUR 62.146,14 per year on a full time basis)
Imagine what you could do at Novartis!
Novartis are 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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