Senior Research Scientist - Analytical Development (SynTD)(m/w/d)

Elanco Animal Health Incorporated; Monheim am Rhein; Sur place; EUR 90 000 - 135 000; Plein temps

Résumé du poste

Elanco is seeking a Senior Research Scientist - Analytical Development (SynTD) in Monheim, Germany, to lead analytical and dissolution method development within TD. The role involves method development, data interpretation, and external reporting, with opportunities to publish and present scientifically.

You will collaborate with global teams to support drug product development, ensuring adherence to GxP and regulatory expectations, while mentoring emerging talent and driving new technology

Qualifications

• PhD/5+ years pharma development experience or MS/10+ years or BS/15+ years in pharma.
• Strong expertise in chromatographic and dissolution method development, especially with USP apparatus II and IV.

Responsabilités

• Develop and deliver analytical and dissolution methods and specifications per GxP requirements.
• Interpret data, evaluate results, and communicate findings.
• Prepare reports, publications, and presentations for stakeholders and regulatory bodies.
• Contribute to international registration documents and interactions with health authorities.
• Collaborate with manufacturing and regulatory teams for product submissions.
• Drive evaluation and adoption of new technologies in dissolution and analytics.
• Mentor junior staff within Analytical Development.
• Ensure compliance with SOPs, GxP, HSE, and quality standards.

Connaissances

Chromatography (HPLC/UPLC)

Spectroscopy (UV/VIS)

Dissolution method development

Formation

PhD in Analytical Chemistry/Pharmacy/Pharmaceutical Sciences

MS in related field

BS in related field with extensive experience

Outils

HPLC/UPLC instrumentation

UV/VIS spectrophotometers

Dissolution equipment (USP II/IV)

Description du poste

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.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.

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: Senior Research Scientist - Analytical Development (SynTD)

As the Senior Research Scientist - Analytical Development, you will support Elanco's Technical Development (TD) organization. This position is broadly responsible for analytical development activities of animal health products with a concentrated focus in dissolution control strategy and synthetic 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 5 years of experience in pharmaceutical development (preferably analytics), ideally with experience in various dosage forms. M.S. in related field with a minimum of 10 years of experience in the pharmaceutical industry, or B.S. in related field with a minimum of 15 years of experience in the pharmaceutical industry.
• Experience: Strong expertise in chromatographic (HPLC/UPLC), spectroscopic (UV/VIS), and dissolution method development 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: Monheim, Germany

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.