Senior Scientist _ Regulated Market _Injectables

Role & responsibilities Experience: 9-14 years Specialization: Injectable Drug Formulation & Development Key Responsibilities: 1. Formulation Development: Lead the design and optimization of injectable drug formulations, ensuring stability, efficacy, and manufacturability. 2. Pre-Formulation Studies: Conduct compatibility assessments, stability testing, and excipient selection to enhance product quality. 3. Scale-Up & Technology Transfer: Oversee successful scale-up from lab-scale development to pilot and commercial manufacturing, ensuring reproducibility. 4. Sterile Manufacturing Expertise: Manage aspects of sterile formulation processes, including aseptic techniques, lyophilization, and parenteral drug delivery innovations. 5. Regulatory Documentation: Prepare and review CMC documentation for regulatory submissions, ensuring alignment with global health authority requirements (FDA, EMA, etc.). 6. Process Development & Optimization: Implement Quality by Design (QbD) and Design of Experiments (DoE) principles to refine injectable formulation strategies. 7. Cross-Functional Collaboration: Work closely with analytical, manufacturing, and regulatory teams to ensure seamless product development. 8. Troubleshooting & Problem-Solving: Address formulation challenges related to stability, compatibility, and manufacturing scale-up. 9. Innovation in Drug Delivery: Explore novel injectable delivery mechanisms, including depot injections, nanoparticle-based formulations, and biopharmaceuticals. 10. Leadership & Mentorship: Guide junior scientists, fostering innovation and technical excellence in formulation research. Qualifications: PhD/Masters in Pharmaceutical Sciences Extensive experience in sterile injectable formulation development with a strong track record of successful product launches. Expertise in aseptic processing, lyophilization, and excipient compatibility for injectables. Strong knowledge of scale-up processes, technology transfer, and industrial manufacturing practices. Proven ability to develop and optimize parenteral drug formulations, ensuring quality and regulatory compliance. Experience with regulatory pathways, and ANDA submissions. Understanding of bio pharmaceutical characterization for injectable products. Preferred candidate profile Candidate with exp of Pre-Formulation Studies and research Candidate with experience of successful scale-up from lab-scale development to pilot and commercial manufacturing, ensuring reproducibility candidate with Sterile Manufacturing Expertise. candidate with experience in Innovation in Drug Delivery: novel injectable delivery mechanisms, including depot injections, nanoparticle-based formulations, and biopharmaceuticals.