Senior Scientist Product Development Science

vor 1 Woche

Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit

**Company Description**

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 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
and
, 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.

**Additional Information**

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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