Senior Scientist I

vor 3 Wochen

Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit
About the Role

We are seeking a highly skilled Senior Scientist to join our team at AbbVie. As a key member of our Product Development Science & Technology (PDS&T) organization, you will play a critical role in the development of container closure systems (CCS) and manufacturing processes for our parenteral drug product pipeline projects.

Key Responsibilities
  • Lead the development of innovative materials and/or alternate packaging materials, packaging solutions or packaging systems for sterile dosage forms with a focus on Extractables & Leachables (E&L) and compatibility.
  • Provide scientific expertise in E&L evaluation of container closure system (CCS)/process equipment materials for sterile parenteral pharmaceutical and biopharmaceutical products according to external regulatory requirements.
  • Collaborate with cross-functional project teams, suppliers, and third-party laboratories to ensure the development of high-quality CCS and manufacturing processes.
  • Develop and implement scientific strategies to drive innovations in the E&L field and contribute to internal and external consortia.
  • Prepare and review comprehensive scientific and technical documents, including E&L study protocols and reports, validation protocols and reports, analytical test procedures, development reports, design history files, and documents for CMC submissions.
Requirements
  • PhD in Analytical Chemistry, Material Sciences, Chemistry, Physics, or related fields.
  • Expert knowledge in parenteral manufacturing and CCS development in the pharmaceutical, medical device, or biotech industry.
  • Profound knowledge in E&L concepts, functional CCS characterization, and Container Closure Integrity analysis according to a holistic CCI strategy.
  • Experience in analytical method development and validation according to USP, ICH, or other compendial or regulatory requirements.
  • Experience with polymers and material selection for process equipment, container closure systems, and/or medical devices.
  • Broad expertise around regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, packaging materials, and drug/device combination products.
  • Excellent oral communication skills, as well as sound technical writing and documentation competencies.
  • Ability to work independently, respond to changing priorities, and short lead times for multiple tasks.
About AbbVie

AbbVie is a global biopharmaceutical company committed to creating innovative solutions for patients. We are dedicated to advancing the treatment of serious diseases and improving the lives of people around the world. Our company is built on a foundation of diversity, equity, and inclusion, and we strive to create an environment where all employees can thrive.

We offer a comprehensive benefits package, including a competitive salary, comprehensive health and exercise programs, and a wide range of career opportunities in an international organization. If you are passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career opportunity, we encourage you to apply.

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