Senior Scientist Product Development Science & Technology (PDS&T) - Global Material and Parente[...]

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.

We are seeking a Senior Scientist to support the Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T) for New Biologic Entities (NBE).

Compatibility evaluation of a (bio)pharmaceutical drug substances (DS) and drug products (DP) with manufacturing process as well as packaging materials is a key element within the development process and during life cycle management of (bio)pharmaceuticals. Therefore, gaining in depth scientific insights regarding the interaction between process or container closure materials and the DS/DP is a prerequisite to ensure product quality and patient safety.

The candidate will be working on the development of container closure systems (CCS) and manufacturing processes within the PDS&T organization at AbbVie.

The focus of the position will be on scientific investigations of interactions between the DP and so called Extractables & Leachables (E&L) which can originate from process and packaging components. Additionally, the candidate will work on the evaluation, development, and characterization of established and innovative CCS for AbbVie’s parenteral drug product pipeline projects. This includes initiation, coordination, and scientific oversight for analytical activities at AbbVie and third-party laboratories (TPLs) according to compendial requirements and applicable guidelines. In addition, the candidate should scientifically drive innovations in the E&L field by actively contributing to internal as well as external consortia.

The position will involve a combination of laboratory experimental work, documentation, project management, and a high level of interaction with cross functional project teams, suppliers, and TPLs.

Main Responsibilities:

• Lead, design, and evaluate the development of innovative materials and/or alternate packaging materials, packaging solutions or packaging systems for sterile dosage forms with focus on E&L and compatibility
• Expert Knowledge regarding E&L evaluation of container closure system (CCS)/process equipment materials for sterile parenteral pharmaceutical and biopharmaceutical products according to external regulatory requirements (e.g. USP <661> and <665>, ISO10993, ICHQ3D)
• Provide scientific advice for E&L evaluations for process equipment (e.g. disposables) and CCS development
• Provide assistance for quality and regulatory activities including preparation of technical documents for regulatory filings
• Management and exchange of scientific knowledge on E&L and CCS/process equipment characterization in general within AbbVie globally and external benchmarking
• Prepare and review comprehensive scientific and technical documents, including E&L study protocols and reports, validation protocols and reports, analytical test procedures, development reports, design history files and documents for CMC submissions

Qualifications

• Senior Scientist II: Bachelor’s Degree or equivalent education and typically, 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience. Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields.
• Senior Scientist I: Bachelor’s Degree or equivalent education and typically, 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and some experience necessary. Degree in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields.
• Professional training may be substituted for equivalent knowledge gained through work experience as an Associate Scientist/Scientist

• Experience in analytical method development and validation according to USP, ICH or other compendial or regulatory requirements
• Experience with polymers and material selection for process equipment, container closure systems and/or medical devices
• Excellent oral communication skills as well as sound technical writing and documentation competencies are required
• Willingness to travel both domestic and international up to 10% of the time
• Able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions; able to influence without direct authority in multi-disciplinary teams

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!

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.