Principal Research Scientist - Product Development (m/f/d)

Elanco Tiergesundheit AG; Monheim am Rhein; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Elanco is seeking a Principal Research Scientist – Formulation Development to lead the design and optimization of Oral Solid Dosage formulations as part of the Synthetic Technical Development team in Monheim, Germany. You will guide internal and external teams from early development through commercial scale-up, ensuring regulatory and quality standards are met.

The role requires a PhD or 15 years (Master’s) of pharma development experience, strong GMP knowledge, and leadership in a global matrix

Qualifikationen

• Master’s degree in Pharmacy, Chemistry, or related field; PhD preferred.
• 10+ years of experience in pharmaceutical drug product development and process scale-up (PhD) or 15 years with Master’s degree.

Aufgaben

• Lead the design, development, and optimization of Oral Solid Dosage (OSD) formulations, including tablets and medicated chewables.
• Provide technical leadership for OSD formulation development across full product life cycle.
• Collaborate with R&D, manufacturing, quality, and regulatory teams to meet global development milestones.
• Oversee external partners (CROs/CDMOs) and ensure GMP, HSE, and SOP compliance.
• Author and review CMC sections for regulatory submissions and mentor scientists.

Kenntnisse

Leadership

Cross-functional collaboration

GMP knowledge

Regulatory knowledge

CMC

QbD

English fluency

Mentoring

Formulation development expertise

Ausbildung

Master’s degree in Pharmacy or Chemistry

PhD preferred

Jobbeschreibung

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: Principal Research Scientist – Formulation DevelopmentAs Principal Research Scientist – Formulation Development, you will join Elanco’s Synthetic Technical Development team in Monheim to lead formulation development for animal health drug products across the full product development life cycle.In this role, you will provide scientific and technical leadership for Oral Solid Dosage (OSD) products and other dosage forms as needed, solve complex formulation challenges, and guide internal teams and external partners from early development through commercial scale-up.Your Responsibilities:Lead the design, development, and optimization of Oral Solid Dosage (OSD) formulations, including tablets and medicated chewables, from enabling formulations and prototype development through final product design and process scale-up and transfer to manufacturing sites.Apply advanced formulation and process expertise in granulation (wet and dry), blending, compression, coating, bioavailability enhancement, controlled release, taste masking, and Quality by Design (QbD) to address complex technical challenges.Partner cross-functionally with R&D, manufacturing and quality, and regulatory teams to deliver global development milestones for animal health drug products.Select and provide technical oversight to external partners, including Contract Research Organizations (CROs) and Contract Development & Manufacturing Organizations (CDMOs),, while ensuring compliance with Good Manufacturing Practice (GMP), Health, Safety and Environment (HSE), and Standard Operating Procedures (SOPs).Author and review Chemistry, Manufacturing, and Controls (CMC) technical sections for regulatory submissions, assess new technologies and in-licensing opportunities, and mentor subject matter experts and developing scientists.What You Need to Succeed (minimum qualifications):Education level — Master’s degree in Pharmacy, Chemistry, or a related scientific field required; PhD preferredA minimum of 10 years of experience in pharmaceutical drug product development and process scale-up with a PhD, or 15 years with a Master’s degreeStrong experience in Oral Solid Dosage (OSD) formulation development and manufacturing processes, including tabletsand/or chewable dosage formsStrong working knowledge of Good Manufacturing Practice (GMP) and global regulatory guidelines, including Veterinary International Cooperation on Harmonisation (VICH) and International Council for Harmonisation (ICH)Proven success bringing pharmaceutical products from laboratory development to commercial scaleLeadership and team skills: ability to operate and lead development activities in a global matrix organizationExcellent written and spoken EnglishWhat will give you a competitive edge (preferred qualifications):Experience developing additional dosage forms such as liquids, topicals, or parenteralsExperience in process transfer between R&D and Manufacturing SitesExperience selecting and managing external development or manufacturing partners, including CROs, CDOs, or CMOsExperience mentoring technical talent and leading subject matter experts in a matrix environmentAdditional Information:Travel: 10–15%Location: Monheim, GermanyElanco 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 statusElanco 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.