Senior Scientist _ Regulated Market _ with Peptides experience

Job Description

Role & responsibilities Experience: 9-14 years Specialization: 14 years of experience in Peptides Key Responsibilities: 1 Design and develop formulations for peptide-based drugs, ensuring stability, efficacy, and optimal bioavailability. 2. Conduct research on novel excipients and innovative drug delivery mechanisms tailored for peptide formulations. 3. Lead scale-up and technology transfer of peptide formulations from lab-scale development to commercial production. 4. Coordinate with analytical teams to perform in-depth characterization studies, including stability profiling and compatibility assessments. 5. Ensure regulatory compliance in formulation strategies, preparing CMC documentation for global regulatory submissions. 6. Optimize formulation processes using QbD and DoE approaches to enhance efficiency and quality. 7. Collaborate with manufacturing and production teams to ensure seamless formulation execution at large-scale levels. 8. Conduct pharmacokinetic and bioavailability studies to refine peptide drug delivery strategies. 9. Lead troubleshooting efforts related to formulation challenges, ensuring robust and scalable peptide drug development. 10. Provide technical leadership, mentoring junior scientists, and fostering innovation in peptide drug formulation. Qualifications: Extensive experience in peptide formulation and drug delivery systems. Expertise in stability studies, compatibility assessments, and formulation troubleshooting. Strong understanding of peptide pharmacokinetics, bioavailability enhancement, and absorption mechanisms. Experience with process development, scale-up, and technology transfer for peptide-based formulations. Knowledge of regulatory pathways, GMP compliance, and preparation of CMC documentation. Ability to develop innovative formulation strategies for improved therapeutic performance of peptide drugs. Proficiency in QbD and DoE methodologies to optimize formulation development processes. Preferred candidate profile Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.