Overview

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.The Senior Research Scientist, Small Molecule API Process Development is responsible for the development and implement of robust, cost effective, and safe commercial routes. Reporting to Senior Director of Global Small Molecule API Development, you will have the opportunity to use your state of art organic synthesis skills to bring new chemical entities to market.

 

Your Responsibilities and Tasks:

  • Development of small molecule APl commercial route and support of regulatory CMC submissions
  • Supervision of work packages at CMOs to ensure API process development and manufacture meeting requirements of quality, efficiency, and safety; responsible for timely delivery of API quantities
  • Hands-on in organic synthesis and compound characterization; evaluation, interpretation, and presentation of scientific data
  • Participation in specification development and documentation preparation
  • Preparation and review of registration relevant documents for worldwide market authorization
  • Evaluation and selection of CMOs for API development including budget forecast and placement of orders, building and maintaining positive business collaboration relationships
  • Securing intellectual property generation for all assigned projects
  • May be responsible for due diligences as a small molecule API development representative and support of license negotiation regarding the CMC part

Basic Qualifications:

  • PhD in organic chemistry or chemical engineering with minimal 4 years of industry experience
  • Experience in route selection and process development/optimization
  • Knowledge with cGMP manufacturing
  • Excellent knowledge in organic synthesis and compound characterization including quantification and solid-state characterization techniques
  • Good organizational skills
  • Strong networking, interpersonal relationship, and intercultural skills as well as excellent communication skills and team spirit
  • Fluent in English, both verbal and written
  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills & Preferences:

  • Experience with production of APIs under cGMP conditions
  • Experience with using statistical tools and principles (e.g. design of experiments)
  • Experience with supporting regulatory submissions
  • Experience with project management
  • Market understanding and strategic mindset working with CMOs

Travel: 5-10% of travel

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

Tagged as: MID TO SENIOR LEVEL

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