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Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
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
Not a perfect match?
- AbbVieFull-timeOn-siteSeniorLudwigshafen am Rhein
- AbbVie
Scientist I/II(m/w/x)
Full-timeTemporary contractOn-siteSeniorLudwigshafen am Rhein - AbbVie
Scientist I – Bioassay Sciences and Development(m/w/x)
Full-time/Part-timeOn-siteExperiencedLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
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
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
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Scientist I/II(m/w/x)
Full-timeTemporary contractOn-siteSeniorLudwigshafen am Rhein - AbbVie
Scientist I – Bioassay Sciences and Development(m/w/x)
Full-time/Part-timeOn-siteExperiencedLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein