Key Responsibilities:
* Independently design, plan, perform or supervise technical and scientific activities in close alignment with the respective project manager and lab scientists.
* Interpretation of results from scientific / technical activities, drawing relevant conclusions and presentation of data to relevant sub-teams.
* Act as a scientific lead of the drug product technical development, accountable for the scientific strategy of development program and technical excellence
* Lead and contribute to various scientific initiatives and workstreams
* 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 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
* Present scientific or technical results to different audiences within or externally.
About the Role:
This is an exciting opportunity to join our team and play a key role in the development of biologic drug products. You will be part of an international, collaborative team located in Austria. We are looking for a passionate scientist to lead a wide range of activities from formulation and process development to technical transfer and submission support.
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.
* Knowledge in data science and statistical data analysis, and passion for and expertise in process modeling, simulation, automation and basic programming (e.g. Python) is an advantage.
* Solid understanding of quality standards and regulations in pharmaceutical industry. Experience in GMP environment is an advantage.
* Strong scientific/technical writing and presentation skills
* Open, curious, problem-solving mindset, good organization skills, team spirit and ability to work in a global, interdisciplinary environment.
* Excellent English required (oral & written)
Salary Information:
The minimum salary is €60,212.18/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.
Benefits and Rewards:
We offer a comprehensive benefits package that includes opportunities for career growth and professional development, flexible working arrangements, and a supportive team environment. If you require an adjustment during the recruitment process due to a medical condition, physical disability or neurodiverse condition, please reach out to us.
Why This Role?
This is an exciting opportunity to join a dynamic team and contribute to the development of innovative scientific solutions that enhance patient quality of life. You will have the opportunity to work on cutting-edge projects and collaborate with experts from around the world. We value diversity, inclusivity and teamwork, and offer a supportive and inclusive work environment. Whether you are just starting your career or looking to take the next step, this role offers opportunities for growth and development.
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