Principal Research Scientist - Product development

Elanco; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Relocation packages

Shutdowns

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Senior Research Scientist for Parenteral Drug Products in Small Molecule at its Indianapolis headquarters. The role centers on formulation development for parenteral dosage forms and coordinating development activities with internal and external partners.

You will apply QbD principles, support regulatory submissions, supervise lab activities, ensure cGMP for sterile products, and collaborate with R&D, manufacturing and CRO/CDO/CMO partners to advance new animal health

Qualifications

• PhD in pharmaceutical science with minimum 5 years in the industry.
• Experience in formulation development of parenteral dosage forms and process scale-up.
• Proven track record with lyophilization, sterile filtration, aseptic filling, and sustained-release injectables.
• Expertise in long-acting and depot dosage forms.
• Strong knowledge of GMP and regulatory guidelines (ICH/VICH) for sterile products.
• Ability to collaborate across Elanco R&D, manufacturing and external partners.
• Innovative mindset.

Responsibilities

• Plan and coordinate daily/weekly formulation lab work with focus on sterile parenteral development.
• Design and revise protocols for aseptic processing and sterile manufacturing.
• Perform data analysis and present results at meetings.
• Oversee external partners and coordinate CRO/CMO activities.
• Maintain lab infrastructure and ensure sterile environment compliance (GxP).
• Prepare registration documents and contribute to submissions.
• Train and coach peers and supervise local team members.

Skills

Parenteral formulation

Aseptic processing

Lyophilization

Sterile manufacturing

ICH/VICH knowledge

Education

PhD in pharmaceutical science

Job description

At Elanco (NYSE: ELAN) - it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better – join our team today!

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

• 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.