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

Elanco Animal Health GmbH; Monheim am Rhein; On-site; EUR 120,000 - 160,000; Full time

Job summary

Elanco Animal Health GmbH in Monheim, Germany, seeks a Principal Research Scientist - Formulation Development to lead formulation development for animal health drug products across the full product development life cycle.

You will provide scientific and technical leadership for Oral Solid Dosage (OSD) products, solve complex formulation challenges, and mentor scientists while coordinating with R&D, manufacturing, quality, and regulatory teams.

Qualifications

• 10+ years in pharmaceutical drug product development and process scale-up (as applicable)
• Experience leading OSD formulation development programs
• Experience interacting with regulatory bodies and preparing CMC sections

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.

Skills

OSD formulation development

GMP knowledge

Regulatory knowledge (ICH, VICH)

Leadership & mentoring

Cross-functional collaboration

English communication

Education

Master's degree in Pharmacy or Chemistry

PhD preferred

Job description

As 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 preferred
• A 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 degree
• Strong experience in Oral Solid Dosage (OSD) formulation development and manufacturing processes, including tablets and/or chewable dosage forms
• Strong 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 scale
• Leadership and team skills: ability to operate and lead development activities in a global matrix organization
• Excellent written and spoken English

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

• Experience developing additional dosage forms such as liquids, topicals, or parenterals
• Experience in process transfer between R&D and Manufacturing Sites
• Experience selecting and managing external development or manufacturing partners, including CROs, CDOs, or CMOs
• Experience mentoring technical talent and leading subject matter experts in a matrix environment

Additional Information:

• Travel: 10-15%
• Location: Monheim, Germany