Senior Scientist II for Extractables and Leachables - PDS&T - Global Material and Parenteral Packaging Sciences

Senior Scientist II for Extractables and Leachables - PDS&T - Global Material and Parenteral Packaging Sciences

AbbVie

Ludwigshafen, Germany

Job Description

In this role, you will contribute to the development and qualification of container closure systems (CCS) and manufacturing processes supporting AbbVie’s parenteral drug product portfolio. The position has a strong scientific focus on Extractables & Leachables (E&L), including the investigation of potential interactions between drug products and materials used in processing and packaging.

You will be responsible for evaluating, developing, and characterizing both established and innovative CCS solutions to support AbbVie’s pipeline and lifecycle programs. This includes planning and coordinating analytical studies, providing scientific oversight of work conducted in AbbVie laboratories and at qualified third‑party laboratories, and ensuring alignment with applicable pharmacopeial standards and regulatory expectations.

As a Senior Scientist, you will represent the function on cross‑functional project teams, collaborate closely with colleagues across development, quality, regulatory, and manufacturing organizations, and engage with external partners and suppliers. You will also have the opportunity to help advance the field of E&L by contributing to internal innovation initiatives and participating in external scientific and industry consortia.

This is what you will cover. In detail you:

• Lead, design, and evaluate the development of innovative materials and/or alternate packaging materials, packaging solutions or packaging systems for sterile dosage forms with focus on E&L, elemental impurities, and compatibility.
• Bring expert knowledge regarding E&L evaluation of container closure system (CCS)/process equipment materials for sterile parenteral pharmaceutical and biopharmaceutical products according to external regulatory requirements (e.g. USP and , ISO10993, ICHQ3D, ICHQ3E).
• Provide scientific advice for E&L evaluations for process equipment (e.g. disposables) and CCS development.
• Help with quality and regulatory activities including preparation of technical documents for regulatory filings.
• are responsible for the management and exchange of scientific knowledge on E&L and CCS/process equipment characterization in general within AbbVie globally and external benchmarking.
• 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.

Qualifications

This is how you make a difference:

• Senior Scientist II: Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience. Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields.
• Professional training may be substituted for equivalent knowledge gained through work experience as an Associate Scientist/Scientist.
• 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.
• Excellent oral communication skills as well as sound technical writing and documentation competencies are required.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions; able to influence without direct authority in multi-disciplinary teams; must be attentive to details and have excellent organization skills.