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ABAbbVie

Senior Scientist II for Extractables and Leachables - PDS&T - Global Material and Parenteral Packaging Sciences(m/w/x)

Ludwigshafen am Rhein
Full-timeOn-siteSenior

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

  • EnglishBusiness 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
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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