Associate Director (m/f/d) – Characterization Analytical Expert

☞ Hexal AG

Ver: 123

Día de actualización: 07-10-2024

Ubicación: Munich Bavaria

Categoría: Farmacéutica / Química / Biotecnología

Industria:

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Contenido de trabajo

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

Your key responsibilities:
Your responsibilities include, but not limited to:

  • Independently manage project activities in the area of analytical characterization (e.g. method-development for characterization of the API, as well as their optimization, validation, -transfer including the know-how and troubleshooting, and ensure their implementations etc.) and contribute to project-specific strategy decisions.

  • Represent own function in technical teams (e.g. global CMC team); perform all project tasks (e.g. design, plan, and support conducting scientific experiments; actively contribute to budget and resource forecast etc.) and responsibilities related to own scope of work, as well as assist leadership team in setting goals, performance evaluations, and development planning discussions with team members.

  • Contribute to Sandoz` strategies and goals by representing analytical characterization in cross functional teams; Provide scientific and technical guidance and develop, mentor, coach other scientific associates. Demonstrate problem solving capabilities for complex tasks and topics of strategic relevance

  • Review and approve analytical results. Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share with the analytical sub-team.

  • Author development reports, study protocols, laboratory procedures, or project-related SOPs; write scientific documents for external partners (e.g., other line units, health authorities). In particular: coordinate and compile high quality analytical registration documents for HA submissions and write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits and inspections.

Diversity and Inclusion

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

Minimum Requirements

What you’ll bring to the role:
Essential Requirements:

  • Doctoral degree in biotechnology, chemistry or other natural sciences and a minimum of 10 years relevant experience in the biopharmaceutical industry and experience in Analytical Project Management.

  • Expert knowledge in the area of analytical characterization of biopharmaceutical products, excellent laboratory and technical expertise (analysis of proteins, antibodies, data evaluation).

  • Thorough understanding of development activities and –processes in biopharmaceutical industry; excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations

  • Proficient scientific/technical writing skills (to compile analytical reports and submission documents in English), and excellent presentation and communication skills
  • Fluent in English (oral and written)

Why Sandoz?
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!

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.

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.

Join our Sandoz Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here:

Global position: https://talentnetwork.novartis.com/sandoztalentpool
Local position: https://talentnetwork.novartis.com/hiringgermany
#Sandoz
Division
SANDOZ
Business Unit
Sandoz Global Development
Location
Germany
Site
Holzkirchen (near Munich)
Company/Legal Entity
Hexal AG
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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Plazo: 21-11-2024

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