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Head of Laboratory Dissolution (all genders)
Ludwigshafen am Rhein
Aktualität: 18.08.2022


18.08.2022, AbbVie Deutschland GmbH & Co. KG
Ludwigshafen am Rhein
Head of Laboratory Dissolution (all genders)
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