Senior Research Scientist for Small Molecule Api - Monheim, Deutschland - Elanco

Elanco

Geprüftes Unternehmen

Monheim, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 stateoftheart 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 pharmaceuticaloriented environment and in crossfunctional 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 businessrelated 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