Job Description Summary
LOCATION: Shaftenaue, Austria
Job Description
Major accountabilities:
Scientific Leadership:
Lead the evolution and implementation of late-phase DSP development approaches, ensuring alignment with early-phase concepts and integration of platform knowledge.
Drive the implementation of digital development strategies that incorporate data-driven decision-making.
Author and review scientific reports intended for internal and external partners and support the preparation of registration documents. Contribute to answers to health authority questions.
Act as a downstream process development expert in health authority inspections or internal audits
Transformation and Innovation:
Oversee and contribute to major scientific and technological transformations, including continued integration of modeling and simulation into late-phase development work packages, implementation of Data & Digital (D&D) initiatives, and advancement of hybrid development concepts.
Capability Building:
Act as a scientific coach to DSP experts. Lead initiatives to upskill the organization, promote scientific rigor, and embed best practices in development workflows.
Project Leadership:
Serve as Functional Lead (FL) or Project Lead (PL) for high-impact late-phase DSP projects, including tech transfers and submissions. Ensure scientific robustness, regulatory compliance, and cross-functional alignment. Identify and mitigate technical and regulatory risks associated with downstream development data packages including prior knowledge and actively drive mitigation strategies
Strategic Interface:
Represent DSP Austria in cross-site and cross-functional fora. Collaborate closely with Technical Operations (TO) and DSP Scientific Office (SO), to ensure seamless integration of development and manufacturing strategies (e.g. ensure facility fit of the processes and applicability of new technologies)
Key performance indicators:
Scientific / Technical Track - Accountability for quality, quantity, and timelines for all assigned tasks.
Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
Feedback from other team members/leaders.
Refer to annual individual and team objective setting.
Outcome of risk analyses, process challenge meetings, audits and inspections.
Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
Internal and external publications/presentations, invited lectures.
Minimum Requirements:
Work Experience:
Ph.D. in biotechnology, biochemical engineering, biochemistry, molecular biology, biology, chemistry, chemical engineering, or a related field with 6+ years of relevant experience; or a Master's degree with 8+ years of relevant experience.
Proven track record of leading downstream process development in the pharmaceutical or biotechnology industry.
Skills:
Good overview of current trends and upcoming techniques for current and future applications including modeling and simulation advancements
Strong understanding of regulatory requirements and experience in preparing regulatory submissions.
Excellent problem-solving skills and the ability to address complex scientific and technical challenges.
Demonstrated ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
Outstanding communication and interpersonal skills, strong leadership and mentoring abilities, no direct people manager responsibility.
Advanced knowledge in a wide range of downstream process development activities, including chromatography, ultrafiltration/diafiltration, viral clearance studies, expertise in Biologics Process Analytics and DP process development
Project management
Languages :
English.
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