Scientist • langenfeld rheinland
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 ch... Mehr anzeigen
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 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 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 Headquarter Indianapolis, US