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Senior Scientist II for Extractables and Leachables - PDS&T - Global Material and Parenteral Packaging Sciences(m/w/x)
Evaluating extractables and leachables for sterile dosage forms and process equipment. PhD with 4+ years experience in analytical chemistry or material sciences required. 6 weeks vacation, company car for private use.
Requirements
- Bachelor's degree or equivalent education and 12 years of experience
- Master's degree or equivalent education and 10 years of experience
- PhD and 4 years of experience
- Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields
- Professional training substituted for equivalent work experience
- Experience in analytical method development and validation
- Adherence to USP, ICH or other compendial/regulatory requirements
- Experience with polymers and material selection
- Experience with process equipment, container closure systems, and/or medical devices
- Excellent oral communication skills
- Sound technical writing and documentation competencies
- Ability to work independently
- Ability to respond to changing priorities and short lead times
- Ability to identify problems and work toward solutions
- Ability to influence without direct authority in multi-disciplinary teams
- Attentiveness to details
- Excellent organization skills
Tasks
- Lead development of innovative materials and packaging solutions for sterile dosage forms
- Evaluate packaging materials and systems for sterile dosage forms
- Assess E&L, elemental impurities, and compatibility for sterile dosage forms
- Apply expert knowledge to E&L evaluation of container closure systems
- Evaluate E&L for process equipment materials for pharmaceutical products
- Provide scientific advice for E&L evaluations of process equipment
- Provide scientific advice for CCS development
- Assist with quality and regulatory activities
- Prepare technical documents for regulatory filings
- Manage and exchange scientific knowledge on E&L
- Manage and exchange scientific knowledge on CCS characterization
- Conduct external benchmarking on E&L and CCS characterization
- Prepare scientific and technical documents
- Review scientific and technical documents
- Prepare E&L study protocols and reports
- Review E&L study protocols and reports
- Prepare validation protocols and reports
- Review validation protocols and reports
- Prepare analytical test procedures
- Review analytical test procedures
- Prepare development reports
- Review development reports
- Prepare design history files
- Review design history files
- Prepare documents for CMC submissions
- Review documents for CMC submissions
- Represent the function on cross-functional project teams
- Collaborate with colleagues across development
- Collaborate with colleagues across quality
- Collaborate with colleagues across regulatory
- Collaborate with colleagues across manufacturing
- Engage with external partners and suppliers
- Contribute to internal innovation initiatives
- Participate in external scientific consortia
- Participate in external industry consortia
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- USP
- ICH
Benefits
Competitive Pay
- Attractive salary
Informal Culture
- Diverse work environment
- Open corporate culture
- Great Place to Work recognition
- Inclusive culture
Mentorship & Coaching
- Intensive onboarding process
- Mentor support
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
- Equality, equity, diversity and inclusion
- Dignity and respect for employees
- Individual contributions valued
Career Advancement
- Wide career opportunities
- Attractive development opportunities
- Strong international network
Sustainability Focus
- Environmental and community focus
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Senior Scientist II for Extractables and Leachables - PDS&T - Global Material and Parenteral Packaging Sciences(m/w/x)
Evaluating extractables and leachables for sterile dosage forms and process equipment. PhD with 4+ years experience in analytical chemistry or material sciences required. 6 weeks vacation, company car for private use.
Requirements
- Bachelor's degree or equivalent education and 12 years of experience
- Master's degree or equivalent education and 10 years of experience
- PhD and 4 years of experience
- Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields
- Professional training substituted for equivalent work experience
- Experience in analytical method development and validation
- Adherence to USP, ICH or other compendial/regulatory requirements
- Experience with polymers and material selection
- Experience with process equipment, container closure systems, and/or medical devices
- Excellent oral communication skills
- Sound technical writing and documentation competencies
- Ability to work independently
- Ability to respond to changing priorities and short lead times
- Ability to identify problems and work toward solutions
- Ability to influence without direct authority in multi-disciplinary teams
- Attentiveness to details
- Excellent organization skills
Tasks
- Lead development of innovative materials and packaging solutions for sterile dosage forms
- Evaluate packaging materials and systems for sterile dosage forms
- Assess E&L, elemental impurities, and compatibility for sterile dosage forms
- Apply expert knowledge to E&L evaluation of container closure systems
- Evaluate E&L for process equipment materials for pharmaceutical products
- Provide scientific advice for E&L evaluations of process equipment
- Provide scientific advice for CCS development
- Assist with quality and regulatory activities
- Prepare technical documents for regulatory filings
- Manage and exchange scientific knowledge on E&L
- Manage and exchange scientific knowledge on CCS characterization
- Conduct external benchmarking on E&L and CCS characterization
- Prepare scientific and technical documents
- Review scientific and technical documents
- Prepare E&L study protocols and reports
- Review E&L study protocols and reports
- Prepare validation protocols and reports
- Review validation protocols and reports
- Prepare analytical test procedures
- Review analytical test procedures
- Prepare development reports
- Review development reports
- Prepare design history files
- Review design history files
- Prepare documents for CMC submissions
- Review documents for CMC submissions
- Represent the function on cross-functional project teams
- Collaborate with colleagues across development
- Collaborate with colleagues across quality
- Collaborate with colleagues across regulatory
- Collaborate with colleagues across manufacturing
- Engage with external partners and suppliers
- Contribute to internal innovation initiatives
- Participate in external scientific consortia
- Participate in external industry consortia
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- USP
- ICH
Benefits
Competitive Pay
- Attractive salary
Informal Culture
- Diverse work environment
- Open corporate culture
- Great Place to Work recognition
- Inclusive culture
Mentorship & Coaching
- Intensive onboarding process
- Mentor support
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
- Equality, equity, diversity and inclusion
- Dignity and respect for employees
- Individual contributions valued
Career Advancement
- Wide career opportunities
- Attractive development opportunities
- Strong international network
Sustainability Focus
- Environmental and community focus
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
Scientist I/II(m/w/x)
Full-timeTemporary contractOn-siteSeniorLudwigshafen am Rhein - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(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
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