Senior Scientist Lead, Drug Product

Bavarian Nordic A/S; Martinsried; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Manufacturing Science Lead to oversee Drug Product processes for vaccine development. This role involves collaborating with cross-functional teams to implement strategies that ensure the successful validation and production of life-saving vaccines. You will influence critical manufacturing processes and contribute to global health initiatives. Join a dedicated team in a dynamic environment where your work will have a significant impact on the safety and well-being of millions. If you are a motivated professional ready to make a difference, this opportunity is for you.

Leistungen

Professional growth opportunities

Flexible working environment

Impactful work in global health

Collaborative team culture

Qualifikationen

• 5+ years experience in Drug Product Manufacturing processes.
• Knowledge of EU and US cGMP and regulatory guidelines.

Aufgaben

• Develop strategies for Drug Product manufacturing processes.
• Drive technical solutions for formulation and filling.

Kenntnisse

Drug Product Manufacturing

Formulation

Filling

Freeze-drying

Visual Inspection

cGMP Knowledge

Project Management

Regulatory Guidelines

Ausbildung

M.Sc. in Engineering, Biology, or Biochemistry

PhD in relevant field

Jobbeschreibung

Are you driven by setting the right strategies for drug product manufacturing development and validation to ensure new vaccines reach the market with the purpose of protecting lives every day?

We are thrilled to offer an exciting job opportunity for a Senior Manufacturing Science Lead role for Drug Product to oversee strategies for the establishment, development, validation, and characterization of all Drug Product processes related to the development and acquisitions of new vaccines, as well as supporting the ongoing production of our commercial vaccine portfolio.

Boost our Team

In the Global Manufacturing Science & Technology (MSAT) department, we are approximately 50 people responsible for strategies and execution of Tech Transfer and Process Performance Qualification (PPQ) for all manufacturing processes, strategies for technical life cycle activities, establishment and maintenance of specifications and shelf life for products, Virus Seeds and Cell Banks, strategies for new materials implementation, incl. specifications for liquids and primary packaging, general impurities and integrity assessments and associated studies, as well as data and statistical support.

You will collaborate with Global and local MSAT colleagues at our manufacturing sites in Bern and Kvistgård, External Manufacturing, QC labs, QA, Supply Chain, Medical Affairs, and Regulatory Affairs. You will work in cross-functional teams to develop strategies and implement technical solutions for all of our Drug Product manufacturing processes.

This role can be based in Kvistgaard, Denmark; Bern, Switzerland; or Munich, Germany, with some travel activities 10-20 % to our different sites and our Contract Manufacturing Organizations (CMOs). You will report to the Senior Director for Global MSAT in Denmark.

Your Impact

You will be responsible for:

• Strategies for the development and validation of Drug Product manufacturing processes
• Driving technical solutions for formulation, filling, freeze-drying, and visual inspection
• Coordinating activities for Drug Product according to company goals and strategies and present status and solutions to Steering Committees and Management meetings
• Being the primary contact person for Drug Product CMC, Tech Transfer, and Manufacturing Development in collaborations with external partners

Are you our next pioneer?

To succeed in this role, you will need:

• A M.Sc. in Engineering, Biology, Biochemistry, or similar, a PhD is an advantage
• Min. 5 years experience with implementation of and/or support to Drug Product Manufacturing processes in the pharmaceutical industry, including formulation, filling, freeze-drying, and visual inspection
• Knowledge about EU and US cGMP and relevant regulatory guidelines
• Proficiency in English. Fluency in Danish or German is a plus

About you

We are seeking a flexible, organized, self-motivated, and resourceful professional with a humble approach to tasks who thrives both independently and as a collaborative team player.

Why join us?

• You will have influence on strategies for Drug Product manufacturing processes for all development and commercial products, as well as on your role and areas of responsibility within a constantly evolving department, with opportunities to take on new responsibilities
• Opportunities for professional growth and development
• Join a team of dedicated colleagues in a flexible and dynamic working environment
• Be part of a team that directly contributes to global health by manufacturing and developing life-saving vaccines
• Your work here has a visible and significant impact, ensuring the safety and well-being of millions

Ready to make a Difference? Apply Now!

Apply by clicking the ‘APPLY’ button. We are interviewing on an ongoing basis and look forward to receiving your motivated CV, in which you state your motivation for applying for this particular role. A cover letter is not required.

Please contact Sara Post Hansen, Senior Director, Head of Global MSAT, at [phone] if you have any questions about the role.

For us, it is all about improving and saving lives

Improving and saving lives through innovative vaccines is at the heart of what we do in Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and the largest pure-play vaccine company in the world.

In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of more than +1600 dedicated employees with diverse backgrounds and viewpoints, who are bound together by our commitment to protect lives every day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development because we need each other to take things further.

We operate in a world in constant flux and always explore new opportunities. So, if you are open-minded and have the willpower to succeed, we might be a perfect fit for you.

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Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
www.bavarian-nordic.com

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Location: Kvistgaard - Hejreskovvej 10A

Additional location:

• Martinsried
• Bern