Senior Analytical Development Scientist
vor 2 Wochen
Job Summary
We are seeking a highly skilled Principal Scientist to join our team at Elanco in Monheim, Germany. The successful candidate will be responsible for developing and delivering relevant analytical and dissolution methods and specifications.
Main Responsibilities
- Develop, deliver, and implement analytical and dissolution methods and specifications ensuring compliance with industrial and regulatory requirements.
- Interpret results, evaluate data, and draw relevant conclusions.
- Report and present scientific/technical results internally, create external publications, and present at scientific conferences.
- Partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities.
- Drive the evaluation and implementation of new technologies in dissolution and analytical development.
- Mentor and coach emerging technical talent within the function.
- Ensure compliance with external and internal guidelines/quality standards.
Requirements
- PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical development.
- Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, and recognized expertise in dissolution particularly with USP Apparatus II (Paddles) and IV (Flow Cell).
- Extensive knowledge of current quality and regulatory requirements for new drug products.
- Demonstrated track record of interactions with regulatory agencies.
- Proven scientific leadership skills.
Preferred Qualifications
- Strong dissolution development experience and submitting to agencies.
- Experience working in regulated environments.
- Strong collaborator with the ability to positively impact interdisciplinary and international teams.
- Strong problem-solving skills, including strategic and creative thinking.
What We Offer
- Freedom for personal initiative and opportunities for individual further training.
- Work in a dynamic team.
- Subsidization of pension provision by the employer.
- 30 days' vacation.
- Health and fitness offerings in an international company.
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