Senior Research Scientist for Parenteral Drug Products in Small Molecule Technical Development (m/f/d)
Elanco
2 months ago
On-site
Indianapolis, IN
Clinical Research and Development
Senior Research Scientist for Parenteral Drug Products in Small Molecule Technical Development (m/f/d)
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.
- 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 strong working knowledge of cGMP for sterile product manufacturing and quality control.
- Understanding and strong working knowledge of GMP and industry/global regulatory guidelines (e.g., VICH and ICH) pertaining to sterile 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 and good German knowledge.
- Proven ability to collaborate effectively across diverse R&D teams and external partners.
- Innovative mindset and proactive problem-solving approach.
- Ability to work effectively and flexibly within and across R&D teams, manufacturing, and external collaborators.
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.
- 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 strong working knowledge of cGMP for sterile product manufacturing and quality control.
- Understanding and strong working knowledge of GMP and industry/global regulatory guidelines (e.g., VICH and ICH) pertaining to sterile 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 and good German knowledge.
- Proven ability to collaborate effectively across diverse R&D teams and external partners.
- Innovative mindset and proactive problem-solving approach.
- Ability to work effectively and flexibly within and across R&D teams, manufacturing, and external collaborators.