Senior Expert Science & Technology, Drug Product Development (m/f/d)

Job title:

Senior Expert Science & Technology, Drug Product Development (m/f/d)

Company

Novartis

Job description

Job Description Summary Location: Schaftenau, AustriaRole Purpose:
At Technical Research & Development – Biologics, we are dedicated to bringing innovative scientific solutions to our patients. Our commitment to excellence drives us to develop cutting-edge biologic drug products that enhance their quality of life.We are looking for a passionate Scientist to join our team and lead a wide range of activities from formulation and process development to technical transfer and submission support.As a Senior Expert you will play a key role in the development of Biologics Drug Products and be part of an international, collaborative team, located in Schaftenau, Austria. It is an exciting time to join us on our journey to reimagine medicine for the patients!Job DescriptionYour 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 Novartis or externally.

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. Phyton) 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 organizations skills, team spirit and ability to work in a global, interdisciplinary environment.
• Excellent English required (oral & written)

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 €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.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 [email protected] 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

Expected salary

€60212.18 per year

Location

Österreich

Job date

Thu, 01 May 2025 02:23:06 GMT

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