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Senior Analytical Development Scientist

vor 2 Monaten


Monheim am Rhein, Nordrhein-Westfalen, Deutschland Elanco Vollzeit
About the Role

We are seeking a highly skilled and experienced Senior Analytical Development Scientist to join our team at Elanco. As a key member of our analytical development team, you will be responsible for developing and delivering analytical and dissolution methods and specifications that meet industrial and regulatory requirements.

Key Responsibilities
  • Develop and deliver analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
  • Interpret results, evaluate data, and draw relevant conclusions.
  • Report and present scientific/technical results internally, create external publications, and present at scientific conferences.
  • Write or support the generation of international registration documents and interact with global health authorities.
  • 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, applying the latest scientific thinking to help bring new drug products to market.
  • Mentor and coach emerging technical talent within the function.
  • Ensure compliance with external and internal guidelines/quality standards (SOPs, GxP, HSE, and AW).
Requirements
  • PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical development (preferably analytics), ideally with experience in various dosage forms.
  • 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 (FDA/CVM, EMA) analytical topics.
Preferred Qualifications
  • Strong dissolution development experience and submitting to agencies.
  • Experience working in regulated environments (GMP).
  • Proven scientific leadership skills.
  • Strong collaborator with the ability to positively impact interdisciplinary and international teams.
  • Strong problem-solving skills, including strategic and creative thinking.
  • Experience in analytical method development in areas outside of dissolution.
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.
  • Subsidized Job Ticket and bike leasing.