Principal Scientist, Analytical Development (SMOL), (m/f/d)

Principal Scientist, Analytical Development (SMOL), (m/f/d)

Elanco Monheim, North Rhine-Westphalia, Germany

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At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Principal Scientist, Analytical Development (SMOL), (m/f/d)
As the Principal Scientist, Analytical Development, you will support Elanco’s Technical Development (TD) organization and report to the Head of Analytical Development SMTD (Small Molecule Technical Development). This position is broadly responsible for analytical development activities of animal health products with a concentrated expertise in dissolution control strategy and small molecule analytical development. As part of technical development teams, the role is expected to support drug development with a diverse range of responsibilities.
Your Responsibilities:

• Develop and deliver relevant 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 (e.g., SOPs, GxP, HSE, and AW).

What You Need to Succeed (minimum qualifications):

• Education: 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. M.S. in related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in related field with a minimum of 16 years of experience in the pharmaceutical industry.
• Experience: 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).

Top 2 skills:

• Extensive knowledge of current quality and regulatory requirements for new drug products.
• Demonstrated track record of interactions with regulatory agencies (e.g., FDA/CVM, EMA) analytical topics.

What will give you a competitive edge (preferred qualifications):

• Strong dissolution development experience and submitting to agencies
• Experience working in regulated environments (e.g., 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.

Additional Information:

• Travel: Approximately 10% travel required.
• Location: Germany, Monheim. Hybrid Work Environment.

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

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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