Laborleiter (all genders) Biologics Analytical R&D (BARD) (permanent / full-time)

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

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 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? You’ve come to the right place!

Moving mountains together – as Laborleiter (all genders) Biologics Analytical R&D (BARD) (permanent / fulltime)

Lead a laboratory group and act as subject matter expert for HPLC/CDS within Biologics Analytical R&D (BARD), Ludwigshafen. You are responsible for quality control related activities like clinical trial supply release or stability programs to successfully drive our pipeline and life cycle management of early pipeline analytical projects. This includes analytical method development, validation and transfer activities to third party labs.

Responsibilities

• You are responsible for the evaluation, optimization and establishment of innovative analytical methods to characterize and control active pharmaceutical ingredients, stabilizers and excipients in drug substances and drug products as well as related impurities during pharmaceutical development of biological products
• Leading and development a group of scientists to ensure successful and timely execution of BARD projects as well as the development of activities is one of your tasks
• You are keen on establishing and continuously improving approaches related to BARD analytical development concepts across our project portfolio
• You assess analytical test methods for quality control and characterization purposes and can create source documents for agency applications and publications
• You will interpret analytical data and conclude quality relevant parameters and ensure GMP compliant documentation
• As the lead of your group you build strong cross-functional networks in a local and global environment and are responsible for subject matter expert topics (HPLC and CDS) and representation in local and global teams

• Bachelor- or equivalent with typically 10 years (bachelor), 8 year (master) or PhD (some) experience in industry. Professional training may be substituted for equivalent knowledge gained through work experience as an Associate Scientist/Scientist
• Expert knowledge in GMP requirements for analytical laboratories for biological entities (NBEs; including botulinum neurotoxins) is mandatory. This involves e.g. GMP compliant documentation of analytical data, conducting laboratory investigations and profound understanding of standard operating procedures. Experience with electronic lab notebook is beneficial
• Due to previous work, you are very experienced in analytical development for biological entities supporting FIH study initiation up to commercialization. Especially development of analytical methods for protein characterization/identification. Candidate’s portfolio must consist of chromatographic separation techniques like HPLC/UPLC coupled to various detection systems as well as compendial test methods. In depth experience in chromatography data systems Chromeleon and Empower is required
• Experience in Quality by Design (QbD), Design of Experiment (DoE) and statistical interpretation of data (e.g. for Comparability) are an advantage as well as experience in other biological entity related areas like formulation, process development or manufacturing are beneficial
• Strong analytical and problem-solving capabilities and skills
• Ability to multitask and work within timelines
• You have a basic understanding of both scientific and regulatory requirements in the area of pharmaceutical development
• As a highly motivated, self-driven and results-oriented person with excellent communication and presentation skills are you experienced in a cross-functional, global environment, used to work with teams in a matrix
• As a global acting company, we presume excellent communication skills, including written and oral English

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.

Any questions? Feel free to email as at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!

Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können – unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen: Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.