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Senior project associate

Holzkirchen
Sandoz
Inserat online seit: 10 Mai
Beschreibung

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Your Key Responsibilities:

As a Senior Expert in Science & Technology, you will play a key role in our Analytical Characterization team, with responsibilities including:
Lead and manage analytical tasks in biosimilar projects, coordinate the analytical sub-team functions, ensuring alignment with organizational goals.
Represent Analytical Development in global, multifunctional CMC project teams of assigned projects.
Develop project plans, including timelines, milestones, and resource allocation (incl. budget planning for assigned projects). In particular, design, plan, supervise and monitor all analytical activities of assigned teams/projects (including characterization of the API, method-development, -transfer and -validation, specification setting, release and stability testing, know-how transfer, etc)
Coordinate international, cross-functional teams to ensure seamless project execution. Work closely with internal and external project partners.
Coordinate and compile high quality analytical registration documents for HA submissions and, potentially, write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits, inspections.
Ensure compliance with regulatory requirements/guidelines and industry standards.
Identify and mitigate project risks.
Foster a collaborative and high-performance team environment.
Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share within the team.
Provide scientific and technical guidance, actively drive knowledge exchange. Develop, mentor and coach principal scientists and other scientific associates.

Your Qualifications:
Degree in Chemistry, Biochemistry, or a related field and at least 6 years relevant experience in the biopharmaceutical industry. A Master’s or Ph.D. is preferred.
Proven experience in analytical project management. Broad theoretical and scientific knowledge in other areas (e.g. biotech manufacturing, pharmaceutical).
Strong communication and interpersonal skills.
Strong knowledge of analytical techniques and methodologies.
Excellent organizational and leadership skills.
Good sense for innovation, strategic thinking und open minded personality.
Fluent in English (oral and written)

Preferred Skills:
Experience in the pharmaceutical or biotechnology industry.
Knowledge of regulatory requirements (e.g., FDA, EMA).
Proficient scientific/technical writing skills and excellent presentation skills.

Language:
~ English and German


You’ll receive:

Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.


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

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