AbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Full-time/Part-timeOn-siteSenior
Ludwigshafen am Rhein
New Job?Nejo!
Your personal AI career agent
ABAbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Ludwigshafen am Rhein
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Developing analytical control strategies for biological assets in drug development. Extensive experience in a scientific discipline required. Flexible work models, intensive onboarding with mentor.
Requirements
- BS or equivalent education and extensive experience
- MS or equivalent education with typically 12+ years of experience
- PhD with typically 6+ years of experience in area or scientific area of discipline
- Bachelor’s Degree in Science related field with 16 years of related work
- Master’s Degree Science or PharmD with 14 years of related work
- PhD in Science or related field with 8 years of related work experience
- Comprehensive knowledge of protein analytics and bioassays
- Knowledge of protein extended characterization
- Experience in regulated quality control environment
- Experience in analytical development of proteins and antibodies
- Experience in analytical development of protein derivatives
- Thorough understanding of ICH regulatory requirements
- Thorough understanding of EMA regulatory requirements
- Thorough understanding of FDA regulatory requirements
- Experience in communication with external partners
- Experience in work with external partners
- Experience with cooperations
- Experience with external laboratories
- Experience in early stage biologic development
- IND exposure
- Excellent communication skills
- Fluent English
Tasks
- Represent Early Bio CMC Analytical Function in global Product Development Strategy Teams
- Develop and implement analytical control strategies for biological assets
- Collaborate with Formulation Lead, Device Lead, and other development functions
- Conceive and execute analytical development strategies to meet CMC project goals
- Design and deliver analytical work packages, including stability and comparability studies
- Cover a range of analytical test methods for quality control and characterization
- Prepare and participate in regulatory agency interactions and meetings
- Manage analytical programs with external partners
- Create and author project-level analytical documents and plans
- Consolidate and summarize analytical test results
- Engage with analytical experts on scientific and project-related issues
- Collaborate with cross-functional SMEs to solve technical issues
- Communicate project strategy, key issues, and risks to the team and management
- Present complex technical topics to the development team and management
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Benefits
Informal Culture
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
Other Benefits
- Company social benefits
- Equality, equity, diversity and inclusion
Career Advancement
- Career opportunities
Learning & Development
- Development opportunities
Sustainability Focus
- Environmental and community focus
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.
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
Drug Product Lead(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AGC Biologics GmbH
Teamlead Bioassay - Quality Control(m/w/x)
Full-timeOn-siteSeniorHeidelberg - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein
ABAbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Ludwigshafen am Rhein
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Developing analytical control strategies for biological assets in drug development. Extensive experience in a scientific discipline required. Flexible work models, intensive onboarding with mentor.
Requirements
- BS or equivalent education and extensive experience
- MS or equivalent education with typically 12+ years of experience
- PhD with typically 6+ years of experience in area or scientific area of discipline
- Bachelor’s Degree in Science related field with 16 years of related work
- Master’s Degree Science or PharmD with 14 years of related work
- PhD in Science or related field with 8 years of related work experience
- Comprehensive knowledge of protein analytics and bioassays
- Knowledge of protein extended characterization
- Experience in regulated quality control environment
- Experience in analytical development of proteins and antibodies
- Experience in analytical development of protein derivatives
- Thorough understanding of ICH regulatory requirements
- Thorough understanding of EMA regulatory requirements
- Thorough understanding of FDA regulatory requirements
- Experience in communication with external partners
- Experience in work with external partners
- Experience with cooperations
- Experience with external laboratories
- Experience in early stage biologic development
- IND exposure
- Excellent communication skills
- Fluent English
Tasks
- Represent Early Bio CMC Analytical Function in global Product Development Strategy Teams
- Develop and implement analytical control strategies for biological assets
- Collaborate with Formulation Lead, Device Lead, and other development functions
- Conceive and execute analytical development strategies to meet CMC project goals
- Design and deliver analytical work packages, including stability and comparability studies
- Cover a range of analytical test methods for quality control and characterization
- Prepare and participate in regulatory agency interactions and meetings
- Manage analytical programs with external partners
- Create and author project-level analytical documents and plans
- Consolidate and summarize analytical test results
- Engage with analytical experts on scientific and project-related issues
- Collaborate with cross-functional SMEs to solve technical issues
- Communicate project strategy, key issues, and risks to the team and management
- Present complex technical topics to the development team and management
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Benefits
Informal Culture
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentorship & Coaching
- Intensive onboarding with mentor
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
Other Benefits
- Company social benefits
- Equality, equity, diversity and inclusion
Career Advancement
- Career opportunities
Learning & Development
- Development opportunities
Sustainability Focus
- Environmental and community focus
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
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Full-time/Part-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Drug Product Lead(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AGC Biologics GmbH
Teamlead Bioassay - Quality Control(m/w/x)
Full-timeOn-siteSeniorHeidelberg - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein