Principal Analytical Development Scientist - Small Molecule

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 Analytical Development Scientist - Small Molecule

As a Analytical Development Scientist - Small Molecule, you will be part of Elanco’s Technical Development (TD) organization, reporting to a team leader of Analytical Development SMTD (Small Molecule Technical Development). In this role, you’ll be responsible for advancing analytical development activities from pipeline entry to regulatory approval, focusing on Quality by Design development and optimization of analytical methods, including dissolution. You will partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities. Additionally, you will drive the evaluation and implementation of new technologies in the field of analytics to help bring new drug products to market.

Your Responsibilities:

• Develop and deliver relevant analytical methods, including dissolution, and specifications.
• Interpret results, evaluate data, and draw relevant conclusions.
• Report and present scientific/technical results internally, potentially create external publications and patents, and present at scientific conferences or congresses.
• Write or support the generation of international registration documents and interact with global health authorities.
• Work effectively and flexibly within and across Elanco R&D teams, manufacturing, and external collaborators.
• Provide and accept challenges to deliver innovative technical solutions and create an innovative culture.
• Mentor and coach emerging technical talent within the function.
• Educate a broad audience, including other functions and management, on current appropriate technology for key applications.
• Incorporate Quality by Design (QbD) principles throughout the development process in alignment with manufacturing commercialization.
• Evaluate new scientific technologies, platforms, and procedures. May participate in the evaluation of in-licensing opportunities or due diligence.
• 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 Pharmacy, Pharmaceutical Sciences, or a similar field.
• Experience: Minimum of 7 years 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.
• Top 2 skills: Extensive knowledge of current quality and regulatory requirements for new drug products, and a demonstrated track record of interactions with regulatory agencies (e.g., FDA/CVM, EMA).
  
  

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

• 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, particularly in dissolution.
  
  

Additional Information:

• Travel: Approximately 10% travel required.
• Location: Monheim am Rhein, Germany, or Greenfield, US. Hybrid Work Environment.
  
  

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages.
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO).
• 8-week parental leave.
• 9 Employee Resource Groups.
• Annual bonus offering.
• Flexible work arrangements.
• Up to 6% 401K matching.
  
  

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