Senior Scientist I – Biologics Analytical R&D (BARD) (all genders) (full-time, temporary for 24[...]

AbbVie Inc; Ludwigshafen am Rhein; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company in Ludwigshafen is hiring a Senior Scientist I for Biologics Analytical R&D. In this full-time role, you will manage analytical methods and quality control activities for drug development. Candidates should have extensive experience in analytical techniques and regulatory knowledge. Join us and contribute to solving serious health challenges, while enjoying a culture committed to diversity and work-life balance.

Leistungen

Attractive salary

Flexible work models

Comprehensive health programs

Career development opportunities

Mentoring during onboarding

Qualifikationen

• 10 years of experience in analytical laboratories for biological entities.
• Experience with chromatographic separation techniques.
• Understanding of scientific and regulatory requirements.

Aufgaben

• Evaluate and establish analytical methods for drug products.
• Ensure timely execution of BARD projects.
• Create source documents for agency applications.

Kenntnisse

Analytical development for biological entities

Strong analytical and problem-solving capabilities

Multitasking and working within timelines

Excellent communication skills in English

Ausbildung

Bachelor's degree

Master's degree

PhD

Tools

HPLC/UPLC

Empower chromatography data systems

Statistical analysis tools

Jobbeschreibung

Company Description

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

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 48,000employees 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? Youve come to the right place!

Moving mountains together – as Senior Scientist I – Biologics Analytical R&D (BARD) (all genders) (full-time, temporary for 24 months)

Be a lab manager and act as subject matter expert for biological analytical methods 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.

Your tasks and 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 within the BARD organization.
• You ensure successful and timely execution of BARD projects in house and/or at a third party lab.
• 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 as well as characterization purposes and create source documents for agency applications and publications.
• You interpret analytical data and conclude quality relevant parameters and ensure GMP-compliant documentation.
• You support the head of quality control through assessment, review and finalization of changes, deviations and out-of-specification investigations
• You build strong cross-functional networks in local and global environments and are responsible for subject matter expert topics along with their representation in local and global teams.

Qualifications

• Senior Scientist I: You hold a bachelor’s degree or equivalent education and typically 10 years of experience, a master’s Degree or equivalent education and typically 8 years of experience, a PhD and no (some) experience necessary.
• Expert knowledge in GMP requirements for analytical laboratories for biological entities (NBEs) 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. Candidate’s portfolio must consist of chromatographic separation techniques like HPLC/UPLC coupled to various detection systems as well as other techniques such as Peptide Mapping, icIEF, CE and compendial test methods. In depth experience in chromatography data systems, e.g.Empower is required.
• Experience in Quality by Design (QbD), Design of Experiment (DoE) and statistical interpretation of data (e.g. for Comparability) are advantageous as well as experience in other biological entity related areas like formulation, process development or manufacturing are beneficial.
• Experience with third party laboratory management is beneficial
• Strong analytical and problem-solving capabilities and skills
• Ability to multitask and work within timelines is mandatory.
• 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 you are 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

Multible 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!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html