Bavarian Nordic Berna GmbH
Senior QA Manager, QV & CSV(m/w/x)
Full-timeWith HomeofficeManagement
Bern
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BABavarian Nordic GmbH
Scientist QC for Stability Programs(m/w/x)
Bern
Full-timeWith Home OfficeSenior
Nejo AI Summary
Managing stability study initiation, planning, sample management, and reporting for vaccines. 5+ years pharmaceutical QC experience in cGMP biotechnology required. Support for personal and academic skills growth.
Requirements
- University degree in natural science
- 5+ years pharmaceutical industry experience
- Focus on quality control and biotechnology in cGMP
- Expertise in stability studies for drug substances
- Expertise in stability studies for drug products
- Knowledge of relevant regulatory requirements
- Experience supporting Health Authority inspections
- Experience participating in Health Authority inspections
- Ability to manage complex programs
- High motivation and ownership
- Strong organizational and planning skills
- Ability to prioritize effectively
- Ability to meet deadlines
- Collaborative mindset
- Ability to build effective working relationships
- Ability to drive solutions
- Proficiency in German
- Proficiency in English
Tasks
- Act as stability program subject matter expert
- Manage local stability study process
- Coordinate stability study initiation, planning, sample management, and reporting
- Monitor and ensure timely execution of stability studies
- Analyze and interpret stability data and reports
- Support decision-making with stability data
- Ensure compliance and inspection readiness of stability programs
- Maintain stability program infrastructure
- Represent stability program during inspections
- Collaborate cross-functionally and across sites
- Harmonize and optimize stability processes
- Contribute to scientific and statistical standards for stability programs
- Support product teams with stability-related activities
- Assist with submissions, program changes, and clinical trial materials
- Provide justification for product shelf life
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Mentorship & Coaching
- Support for personal and academic skills growth
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BABavarian Nordic GmbH
Scientist QC for Stability Programs(m/w/x)
Bern
Full-timeWith Home OfficeSenior
Nejo AI Summary
Managing stability study initiation, planning, sample management, and reporting for vaccines. 5+ years pharmaceutical QC experience in cGMP biotechnology required. Support for personal and academic skills growth.
Requirements
- University degree in natural science
- 5+ years pharmaceutical industry experience
- Focus on quality control and biotechnology in cGMP
- Expertise in stability studies for drug substances
- Expertise in stability studies for drug products
- Knowledge of relevant regulatory requirements
- Experience supporting Health Authority inspections
- Experience participating in Health Authority inspections
- Ability to manage complex programs
- High motivation and ownership
- Strong organizational and planning skills
- Ability to prioritize effectively
- Ability to meet deadlines
- Collaborative mindset
- Ability to build effective working relationships
- Ability to drive solutions
- Proficiency in German
- Proficiency in English
Tasks
- Act as stability program subject matter expert
- Manage local stability study process
- Coordinate stability study initiation, planning, sample management, and reporting
- Monitor and ensure timely execution of stability studies
- Analyze and interpret stability data and reports
- Support decision-making with stability data
- Ensure compliance and inspection readiness of stability programs
- Maintain stability program infrastructure
- Represent stability program during inspections
- Collaborate cross-functionally and across sites
- Harmonize and optimize stability processes
- Contribute to scientific and statistical standards for stability programs
- Support product teams with stability-related activities
- Assist with submissions, program changes, and clinical trial materials
- Provide justification for product shelf life
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Mentorship & Coaching
- Support for personal and academic skills growth
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Bavarian Nordic GmbH
Industry
Pharmaceuticals
Description
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
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