Expert jobs in United States

Analytical Project Lead / Senior Expert Science & Technology (m/f/d)

As Senior Expert Science & Technology (Analytical Project Lead) you will oversee and drive all analytical aspects in Biosimilar development projects from inception to completion. This role requires a strong background in analytical methodologies, project management, technical development and team leadership. Furthermore, as Analytical Project Lead you have to ensure that all projects are delivered on time, within scope as well as within budget.

• 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.

• Degree in Chemistry, Biochemistry, or a related field and at least 8 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)

• Experience in the pharmaceutical or biotechnology industry.


• Knowledge of regulatory requirements (e.g., FDA, EMA).


• Proficient scientific/technical writing skills and excellent presentation skills

Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

• 30 days of annual leave


• Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)


• Company pension schemes and capital formation benefits


• Parental leave


• Other offerings, such as bike leasing

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged!

The future is ours to shape!

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

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Diversity and Inclusion

Division

SANDOZ

Business Unit

Development

Location

Germany

Site

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