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

Elanco

20h

About The Position

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.

Requirements

• 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 to sterile product manufacturing and quality control.

Nice To Haves

• 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.

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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees