Principal Research Scientist I / Biologics Drug Product Lead (R&D) (all genders) (full-time, pe[...]

Allergan Aesthetics; Ludwigshafen am Rhein; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

Ein internationales Gesundheitsunternehmen sucht einen Principal Research Scientist I / Biologics Drug Product Lead in Ludwigshafen am Rhein. Der ideale Kandidat bringt mehr als 12 Jahre Erfahrung in der biologischen Produktentwicklung mit und ist verantwortlich für die strategische Führung in der frühen Produktentwicklung, inklusive der Erstellung von Dokumentationen für regulatorische Einsendungen. Flexibles Arbeitsmodell, ein attraktives Gehalt und ein bedeutender Einfluss auf die Lebensqualität der Patienten sind geboten.

Leistungen

Attraktives Gehalt

Intensives Einarbeitungsprogramm

Flexible Arbeitsmodelle

Umfassendes Gesundheitsmanagement

Qualifikationen

• Mindestens 12 Jahre Berufserfahrung im Bereich Biologics drug product development.
• Thorough understanding der regulatorischen Anforderungen (ICH, EMA, FDA).
• Erfahrung mit neuartigen Projektmodalitäten.

Aufgaben

• Führen des Biologics Drug Product Development Teams als Ansprechpartner.
• Erstellen von Projektunterlagen für die Entwicklung biologischer Produkte.
• Engagement in internationalen Initiativen zur Produktentwicklung.

Kenntnisse

Biologics drug product development

Strukturierte Arbeitsweise

Kommunikationsfähigkeiten in Englisch

Analytische Fähigkeiten

Erfahrung im Qualitätsmanagement

Ausbildung

Master’s Degree in relevant life science discipline

PhD in Science or related field

Tools

GMP regulated environment

Regulatory submission documentation

Jobbeschreibung

Unternehmensbeschreibung

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Stellenbeschreibung

The job that makes possibilities real in patients' lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow's 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? You’ve come to the right place!

Moving mountains together – as Principal Research Scientist I / Biologics Drug Product Lead (R&D) (all genders) (full-time, permanent)

Within R&D Biologics Drug Product Development Germany, the Early Strategic and Technical Development group is seeking an experienced scientist with expert knowledge in Biologics drug product development who aims at taking a lead in developing innovative and patient centric biological products, turning science into medicines.

The scientific background of the incumbent should include formulation, manufacturing process development, container closure systems, quality risk management and analytical development. Solid experience with various molecule types, working in a global team and strategic as well as scientific thinking is a must. Experience with CMC regulatory submission documents and working in a GMP regulated environment is required. Experience working in a matrix leadership is beneficial, as well as analytical experience in e.g. quality control and characterization of biological drug products, and knowledge in device development.

Your tasks and responsibilities

• You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. You work in close collaboration with Analytical Lead, Drug Substance Lead, Device Lead and other development functions represented on the Product Development Strategy Team (e.g. QA, CMC RA, pPDS&T/ late-stage development teams).
• You represent Biologics Drug Product Development Germany in project specific early-stage Development Sciences Core Teams connecting discovery with toxicology, DMPK and drug substance and drug product.
• You translate expert knowledge and project specifics into efficient and patient centric Drug Product development strategies. For this you establish, align, execute and communicate the Product Development strategies to achieve CMC project goals appropriate for the development phase.
• You are accountable for phase appropriate design and timely delivery of the respective Biologics Drug Product Development work packages to meet CMC development objectives.
• You will create project level Drug Product Development documents for Biologics e.g. QTPP, Formulation Declaration, control strategy documentation, CMC sections in regulatory submissions (CTAs, INDs). You consolidate project results/outcome into higher level summary reports.
• You take an active role in regulatory agency interactions (e.g. preparation of scientific advice meeting briefing books, responses to agency requests).
• Furthermore, you actively engage CMC developability, formulation, manufacturing process and container closure system experts locally and globally in scientific, project-related topics, issues and discussions and collaborate with cross-functional SMEs to solve technical issues that arise during development.
• You proactively communicate project strategy, key issues, and risks to the Product Development Strategy Team, to functional management and SMEs and present complex technical topics to the development team and management.
• In addition, you plan personnel (FTE) and budgetary resource requirements for assigned projects and translate project needs into work packages and distribute these within the NBE Drug Product Development Germany functional groups.
• You engage in global initiatives around drug product development.

Qualifikationen

• Master’s Degree in relevant life science discipline (e.g. chemistry, biochemistry, pharmaceutical studies) with 12+ years of related work; PhD in Science or related field with 6+ years of related work experience in minimum of two of the following disciplines: formulation, manufacturing process, container closure system, analytical development, quality risk management and device development
• You possess a comprehensive knowledge in Biologics drug product development, minimally in the areas of formulation, manufacturing process, CCS development, analytical development, quality risk management and drug substance development, and understand the respective business partners objectives.
• You are generally recognized as an established expert in your area of expertise (e.g. formulation, manufacturing process, container closure system development, analytical development).
• You have a thorough understanding of the major regulatory requirements (ICH, EMA, FDA).
• You have experience with novel modality projects and stay curious about new developments.
• As a global acting company, we presume excellent communication skills, including fluent English and German as local language, and the ability to effectively communicate with stakeholders on different levels.
• You have excellent interpersonal skills and easily lead and influence in a matrix environment.
• You have a structured, proactive and reliable way of working and excellent organizational skills.
• You feel comfortable dealing with ambiguity and are able to make decisions taking appropriate risk.

Here's how we can move mountains 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.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Have questions? Email [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.