AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Full-timeOn-siteSenior
Ludwigshafen am Rhein
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ABAbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Ludwigshafen am Rhein
Full-timeOn-siteSenior
Nejo AI Summary
Leading global strategy teams for biologics formulation, manufacturing processes, and container closure systems. Established expertise in a specific technical area and a science PhD or equivalent required. Intensive onboarding with mentor, flexible work models.
Requirements
- BS, Master's, PhD, or equivalent qualification
- Experience in formulation, manufacturing, or analytical development
- Bachelor's, Master's, or PhD in science
- Knowledge in Biologics drug product development
- Established expert in specific technical area
- Understanding of ICH, EMA, FDA regulations
- Experience with novel modality projects
- Excellent communication and stakeholder management skills
- Interpersonal skills and matrix environment leadership
- Structured, proactive, and reliable working style
- Comfort with ambiguity and risk-based decision-making
Tasks
- Lead biologics drug product development on global strategy teams
- Act as the primary contact for drug product topics
- Develop formulations, manufacturing processes, and container closure systems
- Collaborate with cross-functional experts from discovery to operations
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC project goals
- Deliver drug product work packages for early-stage assets
- Create regulatory documents including QTPP and CMC sections
- Consolidate project results into high-level summary reports
- Participate in regulatory agency interactions and scientific advice
- Manage technical issues with local and global experts
- Oversee drug product projects outsourced to external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional groups
- Contribute to global drug product development initiatives
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ICH
- EMA
- FDA
Benefits
Informal Culture
- Diverse work environment
- Open corporate culture
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
- Comprehensive health programs
- Exercise programs
Other Benefits
- Company social benefits
Career Advancement
- International career opportunities
- Strong international network
Learning & Development
- Top-tier development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AbbVie 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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ABAbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Ludwigshafen am Rhein
Full-timeOn-siteSenior
Nejo AI Summary
Leading global strategy teams for biologics formulation, manufacturing processes, and container closure systems. Established expertise in a specific technical area and a science PhD or equivalent required. Intensive onboarding with mentor, flexible work models.
Requirements
- BS, Master's, PhD, or equivalent qualification
- Experience in formulation, manufacturing, or analytical development
- Bachelor's, Master's, or PhD in science
- Knowledge in Biologics drug product development
- Established expert in specific technical area
- Understanding of ICH, EMA, FDA regulations
- Experience with novel modality projects
- Excellent communication and stakeholder management skills
- Interpersonal skills and matrix environment leadership
- Structured, proactive, and reliable working style
- Comfort with ambiguity and risk-based decision-making
Tasks
- Lead biologics drug product development on global strategy teams
- Act as the primary contact for drug product topics
- Develop formulations, manufacturing processes, and container closure systems
- Collaborate with cross-functional experts from discovery to operations
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC project goals
- Deliver drug product work packages for early-stage assets
- Create regulatory documents including QTPP and CMC sections
- Consolidate project results into high-level summary reports
- Participate in regulatory agency interactions and scientific advice
- Manage technical issues with local and global experts
- Oversee drug product projects outsourced to external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional groups
- Contribute to global drug product development initiatives
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ICH
- EMA
- FDA
Benefits
Informal Culture
- Diverse work environment
- Open corporate culture
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
- Comprehensive health programs
- Exercise programs
Other Benefits
- Company social benefits
Career Advancement
- International career opportunities
- Strong international network
Learning & Development
- Top-tier development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AbbVie 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
AbbVie
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
Not a perfect match?
- AbbVie
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Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
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