Senior Research Scientist for Parenteral Drug Products in Small Molecule Technical Development [...]

Elanco; Monheim am Rhein; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global leader in animal health seeks a Senior Research Scientist for Parenteral Drug Products in Monheim, Germany. This role involves leading formulation development for parenteral drug products and advancing drug product lifecycle phases. Candidates need a PhD in Pharmaceutical Science, a minimum of 5 years in the pharmaceutical industry, and at least 3 years in parenteral dosage forms. The position fosters collaboration and requires innovative problem-solving approaches.

Qualifikationen

• Minimum of 5 years of experience in the pharmaceutical industry.
• At least 3 years of expertise in formulation development.
• Strong working knowledge of cGMP for sterile product manufacturing.

Aufgaben

• Lead sterile product development in the formulation lab.
• Design and review scientific protocols for aseptic processing.
• Perform data analysis and troubleshooting for formulation stability.
• Author scientific reports and support registration documents.
• Provide technical guidance to external partners.

Kenntnisse

Formulation development of parenteral dosage forms

Collaboration across diverse R&D teams

Data analysis and troubleshooting

Proficiency in English

Good German knowledge

Ausbildung

PhD degree in Pharmaceutical Science

Jobbeschreibung

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!

Your Role:Senior Research Scientist for Parenteral Drug Products in Small Molecule Technical Development (m/f/d)

As a Senior Research Scientist, you will be part of the Small Molecule Technical Development team to lead formulation development for parenteral drug products. In this role, you’ll be responsible for advancing formulation development throughout the entire drug product development life cycle, including development of formulations for small molecule and peptide drugs, study material supply (GMP and non-GMP), to managing internal lab units and external partnerships, and supporting submissions.

Your Responsibilities:

• Lead the planning, execution, and coordination of sterile product development in the formulation lab, focusing on parenteral small molecule and peptide dosage forms.

• Design, review, and recommend changes to scientific protocols and procedures for aseptic processing and sterile manufacturing.

• Perform data analysis, present results, and troubleshoot issues related to parenteral formulation stability, sterility, and manufacturing processes.

• Author scientific reports, SOPs, and support the preparation of registration documents.

• Oversee and provide technical guidance to external partners, ensuring adherence to cGMP for sterile products.

What You Need to Succeed (minimum qualifications):

• PhD degree in Pharmaceutical Science

• A minimum of 5 years of experience in the pharmaceutical industry

• Min. 3 years of demonstrated expertise in formulation development of parenteral dosage forms, process scale-up, and a strong working knowledge of cGMP for sterile product manufacturing and quality control.

• Understanding and strong working knowledge of GMP and industry/global regulatory guidelines, such as VICH and ICH, specifically pertaining tosterile product manufacturing and quality control.

What will give you a competitive edge (preferred qualifications):

• Expertise in long-acting and depot dosage forms

• Proficiency in English language and good German knowledge

• Proven ability to collaborate effectively across diverse R&D teams and external partners.

• An innovative mindset with a proactive approach to problem-solving.

• Ability to work effectively and flexibly within and across Elanco R&D teams, manufacturing, and external collaborators.

Additional Information:Travel: 5-10% Location: Elanco Monheim, Germany or Elanco Headquarter Indianapolis, US

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