Job Description Summary
LOCATION: Schaftenau, Austria
Job Description
As Functional Lead you will lead, own and drive the scientific strategy and all technical deliverables within complex Biologic Drug Product development projects, working in close partnership with the project manager (project lead). As a core member of the Drug Product Development sub-team, you will be representing scientific and technical excellence and ensure seamless collaboration across all project phases.
Your Responsibilities:
Independently design, plan, perform or supervise technical and scientific activities in close alignment with the respective project manager, lab scientists, involved other functions and external partners.
Deliver development work packages to meet agreed objectives & timelines in the project team and ensure information exchange in the Drug Product sub-team.
Interpretation of results from scientific / technical activities, drawing relevant conclusions and presentation of data to relevant sub-teams.
Lead, manage and execute the technology transfers of drug product manufacturing processes from development sites to internal/external manufacturing sites.
Writing and reviewing of high-quality reports for submissions preparation, review of regulatory Chemistry Manufacturing & Control (CMC) documents and contribution to interactions with health authorities and audits as subject matter expert
Drive and support Root Cause Investigations (RCIs) as well as trouble shooting activities including development of solutions, mitigation plans and reporting risks
As a senior member of the scientific community, you will further contribute to the Drug Product Development Team by:
Leading and contributing to scientific initiatives and workstreams
Presenting scientific or technical results to different audiences within Novartis or externally.
Serving as a scientific leader of the drug product technical development, accountable for the scientific strategy of development program and technical excellence
Requirements:
Ideally PhD or Master in pharmaceutical technology, biotechnology, chemical engineering or other relevant discipline.
Experience (2-5 years) of work related to biotech / pharmaceutical industry with focus on formulation or manufacturing processes development, technical transfer, validation and submission.
Solid understanding of quality standards and regulations in pharmaceutical industry. Experience in Good Manufacturing Practice (GMP) environment is an advantage.
Proficient in development concepts and quality principles such as quality by design and high interest in using innovative tools to inform and speed up product development.
Knowledge in data science and statistical data analysis, and passion for and expertise in process modeling, simulation, automation and basic programming (e.g. Phyton) is an advantage.
Strong scientific/technical writing and presentation skills
Open, curious, problem-solving mindset with interest in working in a dynamic environment requiring flexibility and continuous learning.
Excellent English required (oral & written)
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 € 65,605.54 /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
Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model