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
Biologics drug product formulation and manufacturing process development, designing container closure systems for early-stage assets at a biotech firm. Established expertise in biologics drug product development and regulatory requirements needed. Intensive onboarding with mentor, flexible work models.
Requirements
- BS, Master's, or PhD in relevant life science
- Bachelor's, Master's, or PhD in science related field
- Knowledge in Biologics drug product development
- Established expert in specific development areas
- Understanding of major regulatory requirements
- 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 global drug product development strategy teams
- Act as the primary contact for CMC directors
- Develop formulations and manufacturing processes for biological assets
- Design container closure systems for early-stage products
- Collaborate with analytical, device, and regulatory experts
- Connect discovery teams with toxicology and drug substance functions
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC goals
- Deliver drug product work packages for clinical phases
- Draft regulatory submission documents including CTAs and INDs
- Prepare briefing books for regulatory agency interactions
- Manage technical issues with local and global experts
- Oversee outsourced development projects with external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional development groups
- Participate in 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
- CCS development
Benefits
Competitive Pay
- Attractive salary
Informal Culture
- Diverse work environment
- Open corporate culture
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
Healthcare & Fitness
- Comprehensive health and exercise programs
Other Benefits
- Company social benefits
Career Advancement
- International career opportunities
- Attractive development opportunities
- Strong international network
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
Biologics drug product formulation and manufacturing process development, designing container closure systems for early-stage assets at a biotech firm. Established expertise in biologics drug product development and regulatory requirements needed. Intensive onboarding with mentor, flexible work models.
Requirements
- BS, Master's, or PhD in relevant life science
- Bachelor's, Master's, or PhD in science related field
- Knowledge in Biologics drug product development
- Established expert in specific development areas
- Understanding of major regulatory requirements
- 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 global drug product development strategy teams
- Act as the primary contact for CMC directors
- Develop formulations and manufacturing processes for biological assets
- Design container closure systems for early-stage products
- Collaborate with analytical, device, and regulatory experts
- Connect discovery teams with toxicology and drug substance functions
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC goals
- Deliver drug product work packages for clinical phases
- Draft regulatory submission documents including CTAs and INDs
- Prepare briefing books for regulatory agency interactions
- Manage technical issues with local and global experts
- Oversee outsourced development projects with external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional development groups
- Participate in 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
- CCS development
Benefits
Competitive Pay
- Attractive salary
Informal Culture
- Diverse work environment
- Open corporate culture
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
Healthcare & Fitness
- Comprehensive health and exercise programs
Other Benefits
- Company social benefits
Career Advancement
- International career opportunities
- Attractive development opportunities
- Strong international network
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.
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- AbbVie
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