Scientist QC for Stability Programs (f/m/d)

Bavarian Nordic GmbH; Deutschland; Hybrid; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Bavarian Nordic invites applications for Scientist QC for Stability Programs. The role requires on-site presence in Bern/Törishaus with up to ~20% remote work by agreement.

You will act as SME for the stability program, manage studies, analyze data, ensure inspection readiness and support product teams with stability-related activities. The ideal candidate holds a university degree in a natural science and 5+ years in pharma quality control with GMP experience, plus strong German and English

Qualifikationen

• University degree in a natural science or related field.
• 5+ years of pharmaceutical experience in quality control.
• Experience with stability studies and regulatory requirements.

Aufgaben

• Act as subject matter expert for the stability program and own the local stability study management process.
• Coordinate and manage stability studies, including initiation, planning, sample management and reporting.
• Monitor ongoing stability studies and ensure timely execution.
• Analyze and interpret stability data and reports to support decision-making.
• Ensure compliance and inspection readiness of stability programs, including infrastructure and represent the program during inspections.
• Collaborate cross-functionally and across sites to harmonize, optimize and coordinate processes.
• Contribute to the alignment of scientific and statistical standards for stability programs.
• Support product teams with stability-related activities (e.g., submissions, program changes, clinical trial materials) and provide justification for product shelf life.

Kenntnisse

Stability studies

GMP compliance

Quality control

Regulatory knowledge

Project management

German language

English language

Ausbildung

University degree in natural science

Tools

LIMS

SAS

Microsoft Office

Jobbeschreibung

At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against mpox, rabies, tick-borne encephalitis, typhoid fever, cholera, and chikungunya. We excel in R&D innovation, manufacturing, and commercialization, striving to improve health and quality of life for people worldwide, protecting our tomorrow. Join us in our mission to make a difference.

Scientist QC for Stability Programs (f/m/d)

This role requires regular on-site presence in Bern/Törishaus, with the option for up to approximately 20% remote work by agreement.

Your tasks

• Act as subject matter expert for the stability program and own the local stability study management process.
• Coordinate and manage stability studies, including initiation, planning, sample management and reporting.
• Monitor ongoing stability studies and ensure timely execution.
• Analyze and interpret stability data and reports to support decision‑making.
• Ensure compliance and inspection readiness of stability programs, including infrastructure and represent the program during inspections.
• Collaborate cross-functionally and across sites to harmonize, optimize and coordinate processes.
• Contribute to the alignment of scientific and statistical standards for stability programs.
• Support product teams with stability-related activities (e.g., submissions, program changes, clinical trial materials) and provide justification for product shelf life.

About you

• University degree in a natural science (e.g., Chemistry, Biochemistry, Molecular Biology, or a related field).
• 5+ years of experience in the pharmaceutical industry, with a focus on quality control and biotechnology in a cGMP environment.
• Strong expertise in stability studies for drug substances and drug products, including relevant regulatory requirements.
• Experience supporting or participating in Health Authority inspections.
• Demonstrated ability to manage complex programs with a high level of motivation and ownership.
• Strong organizational and planning skills, with the ability to prioritize effectively and meet deadlines.
• Collaborative mindset with the ability to build effective working relationships and drive solutions.
• Proficiency in German and English, both written and spoken.

We provide an opportunity to be part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile global Quality team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills.

Join Bavarian Nordic

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.