Senior Research Scientist Parenteral Drug Products in Molecule

Senior Research Scientist for Parenteral Drug Products in Small Molecule

Elanco Headquarter Indianapolis, US

The role:

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.

Functions, Duties, Tasks:

• 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.

Minimum Qualification (education, experience and/or training, required certifications):

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

Language Requirements:

English

Other Information:

Travel requirement approximately 5-10%

Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

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