Principal Research Scientist - Product development

Elanco; Indianapolis (IN); Hybride; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Multiple relocation packages

Two weeklong shutdowns (US)

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Résumé du poste

Elanco is seeking a Senior Research Scientist for Parenteral Drug Products in Small Molecule Technical Development based in Indianapolis. The role focuses on formulation development across the drug product lifecycle, coordinating GMP/non-GMP material supply, and oversight of internal labs and external partners.

The ideal candidate has a PhD in pharmaceutical science with 5+ years in industry, expertise in parenteral dosage forms, lyophilization, aseptic filling, and strong knowledge of GMP and

Qualifications

• PhD in pharmaceutical science with at least 5 years in industry.
• Experience in parenteral formulation development and process scale-up.
• Proven track record in lyophilization, sterile filtration, aseptic filling, and sustained-release injectables.

Responsabilités

• Plan, execute and coordinate formulation lab activities with focus on sterile products.
• Design and optimize protocols for aseptic processing and sterile manufacturing.
• Perform data analysis and present results to teams.
• Prepare reports and contribute to registration documents.
• Oversee external collaborations and supervise sub-teams as needed.

Connaissances

Formulation development

Parenteral dosage forms

Lyophilization

Sterile manufacturing

GxP knowledge

QbD principles

Regulatory guidelines (ICH/VICH)

Team collaboration

Lab supervision

Formation

PhD in pharmaceutical science

Description du poste

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!

Role Overview

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.

Responsibilities and Duties

• 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 Qualifications

• 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%.

Equal Opportunity Statement

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 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.

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 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 Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.