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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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place!
We are looking for a Head of Laboratory for Dissolution Development to lead the development of phase-appropriate dissolution testing methods for solid oral dosage forms from first-in-human programs through submission of new commercial drug products. AbbVie Analytical Research & Development (Analytical R&D) is a global analytical sciences organization, responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative small molecule and therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.
- As Laboratory Head you are responsible for developing phase-appropriate dissolution methods for new drug products from first-in-human candidates through submission of new commercial drug products
- With your in-depth expertise you successfully establish dissolution strategies for late-phase development to meet global regulatory expectations for dissolution testing
- You are an integral part of interdisciplinary global drug product development teams and work closely with the analytical project leads and relevant functions such as formulation, regulatory, and clinical PK
- You contribute to the overall dissolution strategy by proactively keeping up to date with current developments in scientific and regulatory environment as well as new advances in dissolution instrumentation
- You supervise and develop your team members, while monitoring timely delivery of results and ensuring that regulatory expectations are me
- 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 in pharmacy, chemistry or a related field
- 4+ years of experience in relevant drug product development of solid oral dosage forms with a strong focus on dissolution testing and biopharmaceutics
- Proven track-record in dissolution method development and regulatory filings.
- Experience in analytical development for new chemical entities (NCE) in compliance to GMP expectations.
- Knowledge of amorphous solid dispersions is beneficial
- Strong analytical and problem-solving skills
- Strong leadership skills in successful people management in a global environment
- Strong written and verbal communications skills in English language, German would be a plus
Job Type: Experienced