Scientist II - Process Development (all genders) (full-time, permanent)

Allergan; Ludwigshafen am Rhein; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

AbbVie in Ludwigshafen sucht Scientist II im Bereich Process Engineering, um robuste Herstellungsprozesse zu entwickeln, zu validieren und erfolgreich zu transferieren. Sie arbeiten eng mit cross-funktionalen Teams zusammen und unterstützen globale Produktionsstandorte sowie TPMs.

Der Aufgabenbereich umfasst QbD-gestützte Studien, Prozessoptimierung, technisches Transfermanagement und kontinuierliche Prozessverbesserungen. Reisebereitschaft bis ca.

Qualifikationen

• B. Sc. oder gleichwertige Ausbildung mit ≥7 Jahren Erfahrung.
• M. S. oder gleichwertige Ausbildung mit ≥5 Jahren Erfahrung.
• Erfahrung in der Entwicklung und Herstellung von kleinmolekularen und oralen Peptid-Wirkstoffen in Entwicklungs- und kommerzieller Produktion.
• Starke Fehlersuch- und Problemlösungsfähigkeiten in Prozessen, Material- und Herstellungsfragen.

Aufgaben

• Design, Durchführung, Analyse und Dokumentation von Prozessentwicklungs- und Charakterisierungsstudien.
• Unterstützung bei Scale-up, Validierung, Technology Transfer und Lifecycle-Management.
• On-site-Unterstützung bei Herstellungsaktivitäten, Untersuchung von Abweichungen und Fehlern.
• Verfassen und Review technischer Dokumente wie Protokolle, Berichte und Tech-Transfer-Pakete.

Kenntnisse

Fehlersuche

Datenanalyse

Datenautomatisierung

Teamarbeit

Wissenschaftliches Schreiben

AI/ML-Kenntnisse

Internationale Reisebereitschaft

Ausbildung

B. Sc. oder gleichwertige Ausbildung

M. S. oder gleichwertige Ausbildung

Jobbeschreibung

Unternehmensbeschreibung

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Stellenbeschreibung

Welcome to AbbVie! As part of an international company with 57,000employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as Scientist IIin Process Engineering (all genders)

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 aScientist IIin 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.

Qualifikationen

• 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.

Here's how we can grow together:

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

Any questions? Feel free to email us at [e-mail] – we look forward to hearing from you!

Zusätzliche Informationen

AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich, mit Integrität zu arbeiten, Innovationen voranzutreiben, Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.