Senior Scientist II (all genders) for Extractables and Leachables PDS&T Global Material and Parenteral Packaging Sciences permanent fulltime

People. Passion. Possibilities. Its who we are what we do and what we stand for. 

AbbVie is seeking a Senior Scientist II to join the Global Material and Parenteral Packaging Science team within Product Development Science & Technology (PDS&T) at our Ludwigshafen site supporting the development of New Biologic Entities (NBE).

Compatibility assessment of (bio)pharmaceutical drug substances (DS) and drug products (DP) with manufacturing processes and packaging materials is a critical element of successful drug development and lifecycle management. A thorough scientific understanding of interactions between DS/DP and process or container closure materials is essential to ensuring product quality regulatory compliance and ultimately patient safety.

In this role you will contribute to the development and qualification of container closure systems (CCS) and manufacturing processes supporting AbbVies parenteral drug product portfolio. The position has a strong scientific focus on Extractables & Leachables (E&L) including the investigation of potential interactions between drug products and materials used in processing and packaging.

You will be responsible for evaluating developing and characterizing both established and innovative CCS solutions to support AbbVies pipeline and lifecycle programs. This includes planning and coordinating analytical studies providing scientific oversight of work conducted in AbbVie laboratories and at qualified thirdparty laboratories and ensuring alignment with applicable pharmacopeial standards and regulatory expectations.

As a Senior Scientist you will represent the function on crossfunctional project teams collaborate closely with colleagues across development quality regulatory and manufacturing organizations and engage with external partners and suppliers. You will also have the opportunity to help advance the field of E&L by contributing to internal innovation initiatives and participating in external scientific and industry consortia.

This position offers a dynamic mix of handson laboratory work scientific excellence technical documentation and project leadership along with extensive collaboration across global multidisciplinary teams.

This is what you will detail you:

• 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 elemental impurities and compatibility.
• Bring 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 ICHQ3E)
• Provide scientific advice for E&L evaluations for process equipment (e.g. disposables) and CCS development.
• Help with quality and regulatory activities including preparation of technical documents for regulatory filings.
• are responsible for the 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 :

This is how you make a difference:

• Senior Scientist II: Bachelors Degree or equivalent education and typically 12 years of experience Masters 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.
• 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.
• The candidate must be 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; must be attentive to details and have excellent organization skills.

Additional Information :

Heres 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.

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. 

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Work :

No

Employment Type :

Full-time