Senior Scientist II (all genders) for Extractables and Leachables - PDS&T - Global Material and Parenteral Packaging Sciences - permanent fulltime

Ludwigshafen, GermanyPosted 9 days agoFull-time

Pharmacy & Pharmaceutical

Job description

People. Passion. Possibilities. It’s who we are, what we do, and what we stand for.

AbbVie is seeking a Senior Scientist II to join the Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T) at our Ludwigshafen site, supporting the development of New Biologic Entities (NBE).

Compatibility assessment of (bio)pharmaceutical drug substances (DS) and drug products (DP) with manufacturing processes and packaging materials is a critical element of successful drug development and lifecycle management. A thorough scientific understanding of interactions between DS/DP and process or container closure materials is essential to ensuring product quality, regulatory compliance, and ultimately patient safety.

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 position offers a dynamic mix of hands‑on laboratory work, scientific excellence, technical documentation, and project leadership, along with extensive collaboration across global, multidisciplinary teams.

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 <661> and <665>, 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.

Job details

Job description