Principal Research Scientist - Product development

Elanco•Indianapolis, IN

1d•Onsite

About The Position

This position is responsible for formulation development and related activities associated with the development of animal health products, specifically focusing on parenteral dosage forms within Small Molecule Technical Development. Responsibilities of this role include development activities of the entire drug product development life cycle such as development of prototype formulations, study material supply (GMP and non-GMP), coordination of development activities with internal and external partners, and the management of internal lab unit(s). The person in this role will apply scientific/technical expertise to address complex formulation development tasks within product development and to author documents supporting submissions in coordination with regulatory affairs personnel. This position is expected to incorporate Quality by Design (QbD) principles throughout the development process. The person in this role supports identification and selection of Contract Research/Development/Manufacturing Organizations (CRO/CDO/CMO) and provides technical oversight of external development work.

Requirements

PhD in pharmaceutical science, with proven experience in pharmaceutical industry (minimum 5 years).
Experience in formulation development of parenteral dosage forms and process scale-up with demonstrated record of success.
Proven track record of projects including technologies such as lyophilization, sterile filtration, aseptic filling, and sustained-release injectables.
Understanding and strong working knowledge of GMP and industry/global regulatory guidelines, such as VICH and ICH, specifically pertaining to sterile product manufacturing and quality control.
Ability to work effectively and flexibly within and across Elanco R&D teams, manufacturing, and external collaborators.
Innovative mindset.
English

Nice To Haves

Ideally, brings expertise in long-acting and depot dosage forms.

Responsibilities

Plan, execute and coordinate daily and weekly work schedule in the formulation lab, with a focus on sterile product development, including sustained release and long-acting parenteral small molecule and peptide dosage forms.
Design, review and make recommended changes to scientific protocols and procedures, particularly for aseptic processing and sterile manufacturing.
Perform data analysis.
Present results at team, project or functional meetings.
Perform troubleshooting activities related to parenteral formulation stability, sterility, and manufacturing processes.
Write reports and may write external publications. Prepare SOPs/working procedures. Support preparation of registration documents.
Contribute to evaluation of new scientific technologies and procedures, especially in parenteral drug delivery.
Collaborate with other associates and scientists to facilitate knowledge exchange. Train and coach peers. May supervise local team members.
Maintain infrastructure of laboratory and an organized, clean and safe working environment, adhering to sterile environment protocols. Schedule and perform maintenance of instruments/equipment (if needed). Evaluate new laboratory equipment.
Oversee the work of external partners, evaluate results and define the next steps.
Work according to external and internal guidelines (e.g. SOP’s, GxP, HSE, and AW), with a strong emphasis on cGMP for sterile products.