Senior Research Scientist for Small Molecule Api

Vor 3 Tagen

Monheim, Deutschland Elanco Vollzeit

Education : EQUIVALENTEXPERIENCE

**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**

This Senior Research Scientist, Small Molecule API Analytical Development is responsible for analytical method development and validation, supervision of work carried out by CRO, and authoring of analytical regulatory submission documentation. As part of a diverse global team of API, formulation, analytical, and packaging scientists, you will have the opportunity to use your state of art skills to bring new chemical entities to market.

**YOUR TASKS AND RESPONSIBILITIES**

**Technical leadership in small molecule API analytical development in Research and Development**:

- Enable the design, development, and implementation of analytical methodologies for the characterization and analysis of small molecules including peptides
- Show proficiency in HPLC, LC-MS, solid state property characterization, NMR, or other analytical techniques
- Oversee the development and validation of analytical methods in third party organizations
- Perform statistical analysis of chromatographic data and integrate concepts of DoE into study designs
- Ensure adoption of state-of-the-art technologies and Quality by Design (QbD) development concepts as well as adherence to quality standards
- Establish analytical control strategy and specifications for API that can be transferred into manufacturing and successfully registered globally
- Design and implementation of VICH compliant stability studies conducted by external partners
- Engage with scientists across Elanco’s Development and Manufacturing organizations to develop a deep understanding of new initiatives and improve existing scientific processes
- Authoring of analytical submission documentation and coordination of the CMC sections (Part II CMC, Expert report) of dossiers for worldwide registrations including responding to technical questions from Health Authorities
- Professional input into the development of strategic concepts for the technical registration of animal health products in collaboration with Regulatory Affairs
- Optimization and defense of Elanco marketed products
- Analytical Subject Matter Expert for global project development teams

**WHO YOU ARE**
- PhD in a scientific discipline (e.g., Analytical Chemistry or equivalent) with 3+ years of experience in the pharmaceutical field
- Sound understanding of pharmaceutical analytical chemistry and analytical techniques such as HPLC/UPLC, NMR, solid state property characterization, GC, IR, UV, etc.
- Good working knowledge of ICH and/or VICH guidance and familiarity with GMP regulations
- Experienced in planning, design, and evaluation of Health Authority registration studies and compilation of CMC submission documentation for animal or human health products
- Experienced working in a pharmaceutical-oriented environment and in cross-functional project teams
- Possesses organizational and leadership skills with the ability to lead and inspire a team to deliver results with scientific excellence
- Strong written and verbal communication skills with the ability to translate complex scientific results into clear messages and speak to both technical and business-related implications of your work
- Broad IT skills (e.g., MS Office, eLN, Empower, JMP)

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

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