Job Description Summary
LOCATION: Schaftenau, Austria
Job Description
We are seeking an Associate Director Science & Technology with an impressive background and profound experience in late-phase cell culture USP process development. The Associate Director USP Development is a senior scientific leadership role within Drug Substance Development, responsible for driving innovation, scientific excellence and operational readiness in mammalian cell culture process development for late-phase clinical and commercial manufacturing. This position combines strategic leadership, scientific excellence and project support to ensure robust upstream processes and successful technology transfer to our manufacturing sites.
Your responsibilities:
Strategic Leadership
Shape and execute the department’s strategic vision, including technology roadmaps and process optimization initiatives.
Lead workstreams and contribute to global or local initiatives, such as global guidelines, development manuals or industry consortia
Champion major innovations, including the integration of modeling and simulation into late-phase development, implementation of Data & Digital (D&D) initiatives, and evolution of hybrid development concepts.
Partner effectively across global USP networks and with key functions such as Scientific Office, Downstream Processing (DSP), Analytical Development, Manufacturing Science & Technology (MS&T), Novartis Operations, and Regulatory Affairs.
Scientific Excellence & Capability Building
Promote knowledge exchange locally and globally within scientific networks. Act as scientific coach to USP experts.
Drive innovation in upstream platform technologies and foster continuous improvement. This includes implementation of digital development strategies that incorporate data-driven decision making.
Contribute to scientific publications, conference presentations and intellectual property generation.
Initiate and support academic collaborations to advance scientific capabilities.
Project Support
Coach scientists for all tasks related to late phase development and characterization of upstream cell culture processes, including scale up and tech transfer for manufacturing biotherapeutics.
Support very complex and demanding tasks with high impact and visibility as an USP expert with knowledge in the entire Drug Substance (DS) area
Act as functional USP project lead for “non-standard” requests (time critical, challenging and technically complex tasks, e.g. off-site validation, process transfer, submission and Pre-Approval Inspection (PAI) support for non-platform processes)
Represent the function in governance boards and external collaborations.
Support due diligence for new products and technologies.
Regulatory & Compliance
Author and review Chemistry/Manufacturing/Controls CMC documentation for Investigational New Drug (IND )/ Biologics License Application BLA filings, respond to Request for Information’s (RFIs) and provide audit support
Ensure adherence to applicable compliance and regulatory standards.
What you'll bring to the role:
Education
Experience & Background
Languages
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
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 € 78,383.90 /year (on a full-time basis).
We also offer a potential market oriented excess payment in line with your experience and qualifications.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
Adjustments for Applicants with Disabilities:
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Skills Desired
Budget Management, Coaching Skills, Data Science, Experiments Design, Laboratory, Problem Solving Skills, Process Simulation, R&D, Waterfall Model