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Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Developing analytical control strategies for biological assets in early R&D. Extensive experience in science-related fields required. Flexible work models, corporate health management.
Requirements
- BS or equivalent education and extensive experience
- MS or equivalent education with extensive experience
- PhD with extensive experience
- Bachelor’s Degree in Science related field with extensive work
- Master’s Degree Science or PharmD with extensive work
- PhD in Science or related field with extensive work experience
- Comprehensive knowledge of protein analytics and bioassays
- Versed in protein extended characterization
- Experience in regulated quality control environment
- Experience in analytical development of proteins and antibodies/derivatives
- Thorough understanding of ICH, EMA, FDA regulatory requirements
- Experience in communication with external partners
- Experience working 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, execute, and communicate analytical development strategies
- Design and deliver analytical work packages on time
- Conduct stability and comparability studies
- Manage analytical test methods for quality control and characterization
- Prepare and participate in regulatory agency interactions
- Respond to agency requests and attend agency meetings
- Oversee programs with external partners
- Create and author project-level analytical documents
- Consolidate analytical test results into summary reports
- Engage analytical experts in scientific and project-related discussions
- Collaborate with cross-functional SMEs to solve technical issues
- Communicate project strategy, key issues, and risks
- 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
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
- Health programs
- Exercise programs
Other Benefits
- Company social benefits
- International organization
Career Advancement
- Career opportunities
Learning & Development
- Development opportunities
Informal Culture
- International network
- Great Place to Work recognition
- Home
- Jobs in Germany
- Analytical Lead – Protein Analytics in Early Analytical Development R&DAnalytical Lead – Protein Analytics in Early Analytical D...
Not a perfect match?
- AbbVieFull-time/Part-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 - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Full-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
Scientist I/II – HPLC Characterisation of Monoclonal Antibodies(m/w/x)
Full-timeOn-siteNot specifiedLudwigshafen am Rhein
- Home
- Jobs in Germany
- Analytical Lead – Protein Analytics in Early Analytical Development R&DAnalytical Lead – Protein Analytics in Early Analytical D...
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Developing analytical control strategies for biological assets in early R&D. Extensive experience in science-related fields required. Flexible work models, corporate health management.
Requirements
- BS or equivalent education and extensive experience
- MS or equivalent education with extensive experience
- PhD with extensive experience
- Bachelor’s Degree in Science related field with extensive work
- Master’s Degree Science or PharmD with extensive work
- PhD in Science or related field with extensive work experience
- Comprehensive knowledge of protein analytics and bioassays
- Versed in protein extended characterization
- Experience in regulated quality control environment
- Experience in analytical development of proteins and antibodies/derivatives
- Thorough understanding of ICH, EMA, FDA regulatory requirements
- Experience in communication with external partners
- Experience working 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, execute, and communicate analytical development strategies
- Design and deliver analytical work packages on time
- Conduct stability and comparability studies
- Manage analytical test methods for quality control and characterization
- Prepare and participate in regulatory agency interactions
- Respond to agency requests and attend agency meetings
- Oversee programs with external partners
- Create and author project-level analytical documents
- Consolidate analytical test results into summary reports
- Engage analytical experts in scientific and project-related discussions
- Collaborate with cross-functional SMEs to solve technical issues
- Communicate project strategy, key issues, and risks
- 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
Flexible Working
- Flexible work models
- Healthy work-life balance
Healthcare & Fitness
- Corporate health management
- Health programs
- Exercise programs
Other Benefits
- Company social benefits
- International organization
Career Advancement
- Career opportunities
Learning & Development
- Development opportunities
Informal Culture
- International network
- Great Place to Work recognition
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
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 - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Full-timeOn-siteSeniorLudwigshafen am Rhein - AbbVie
Scientist I/II – HPLC Characterisation of Monoclonal Antibodies(m/w/x)
Full-timeOn-siteNot specifiedLudwigshafen am Rhein