Scientist II - Process Development

Scientist II - Process Development

AbbVie

Ludwigshafen, Germany

The department of Pharmaceutical Products Group is responsible for developing manufacturing processes that enable delivery of AbbVie’s candidate molecules in a dosage form which is intended for product commercialization. We have an exciting opportunity for a Scientist II in the Process Engineering group based in Ludwigshafen, Germany. This role applies sound engineering and scientific principles to solve complex manufacturing challenges, optimize commercial processes and enable successful transfer of new and existing products from R&D to global manufacturing sites and third-party manufacturers (TPMs).

Responsibilities:

• Design, execute, analyze, and document process development, optimization and characterization studies using Quality by Design (QbD) methodologies for small molecule and oral peptide drug product manufacturing processes. Collaborate with cross-functional teams to solve complex engineering challenges and deliver robust, scalable manufacturing processes supporting late-stage development and commercial manufacturing.
• Support process scale-up, process validation, technology transfer, and manufacturing engineering activities for new products and lifecycle management projects across internal and external manufacturing sites
• Provide on-site support for manufacturing activities, investigate manufacturing deviations, process failures, and equipment-related issues using scientific problem-solving and root cause analysis tools, and implement effective corrective and preventive actions.
• Author and review technical documents including development protocols and reports, batch records, production campaign reports, tech transfer packages, and regulatory submissions.
• Collaborate with other drug product development CMC functions to ensure successful product lifecycle management from development through commercialization.
• Contribute technical expertise to cross-functional project teams while managing assigned deliverables and timelines. Actively share technical knowledge, lessons learned, and best practices to promote team development and to foster a collaborative and continuous learning environment.
• Evaluate emerging manufacturing technologies, equipment and engineering approaches to improve process capability, product quality and manufacturing performance.
• Serve as Subject Matter Expert (SME) for department-owned equipment and technologies, support the maintenance and continuous improvement of relevant laboratory and equipment-related procedures.
• Contribute to team initiatives to improve scientific workflows, data management, digital capabilities, data automation, modeling, simulation, and AI-enabled approaches to enhance process understanding, decision-making, and operational efficiency.

Qualifications:

• B. Sc. or equivalent education and 7+ years of experience or M. S. or equivalent education and 5+ or more years of experience.
• Proven experience in small molecule and oral peptide drug product development and manufacturing across oral solid, liquid and suspension dosage forms in both development and commercial manufacturing environments.
• Expertise in material properties and their impact on drug manufacturability and final product performance, with the ability to interpret data for product optimization.
• Strong troubleshooting skills in process, material, and manufacturing issues, with experience applying engineering and scientific principles to support process scale-up and commercial manufacturing.
• Strong scientific problem-solving, scientific writing, communication and presentation, and collaboration skills with the ability to work effectively in multidisciplinary teams.
• Experience or strong interest in applying data automation, statistical modeling, process simulation, and AI/ML-enabled tools to support process development, process characterization, data interpretation, and continuous improvement.
• Willingness and ability to travel internationally for production support, up to 25% of the time.