Technical Transfer Lead (d/f/m), Kundl, Tyrol, Austria
40 years! This is our expertise in Biotech production and a growing product portfolio including proteins as well as new future key technologies such as pDNA and mRNA manufacturing. Join the Manufacturing Science and Technology team in Drug Substance Kundl as Technical Transfer Lead and participate at the frontline in pioneering the future of our Biologics and bringing highly innovative, high quality pharmaceuticals to the patients
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Provide technical leadership for transfer projects to our recombinant protein plants and nucleic acid facilities (NAF) and liaise efficiently with involved functions (e.g. technical development, supply chain, QA, QC, HSE, BD, BTC, other sites, etc.);
• Act as single point of contact (SPOC) on site for technical transfers: Lead and steer 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.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
•: University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering or equivalent degree.
• Minimum 5 years of relevant professional experience in manufacturing / tech transfer management / 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.
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group.
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 € 52,204.04/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job sharing models and support flexible and remote working where possible.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
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