Process Development Lab (Injectable) - Research Associate

Job Description

Job Overview: The PDL Scientist - Injectable will be responsible for the development, optimization, and scale-up of sterile injectable formulations and manufacturing processes. The role demands expertise in injectable formulation science, process engineering, and compliance with regulatory and quality standards. Role & responsibilities Formulation Development: Design and optimize sterile injectable formulations, including solutions, emulsions, and suspensions. Perform compatibility and stability studies of active pharmaceutical ingredients (APIs) with excipients. Process Optimization: Develop robust, scalable manufacturing processes for injectable formulations. Define and optimize critical process parameters (CPP) and quality attributes (CQA). Sterility Assurance: Establish aseptic processes and ensure compliance with sterility requirements. Perform filtration studies, autoclave cycle development, and validation. Analytical Support: Collaborate with the analytical team for the development and validation of testing methods. Conduct particle size analysis, pH, and osmolarity evaluations, and other critical tests. Regulatory Compliance and Documentation: Prepare technical reports, batch records, and regulatory submissions in compliance with GMP, ICH, and FDA guidelines. Support regulatory inspections and audits with comprehensive process documentation. Technology Transfer: Facilitate the transfer of processes from lab-scale to manufacturing-scale environments. Work closely with cross-functional teams, including production, quality assurance, and regulatory affairs. Preferred candidate profile 3 - 5 years of experience in injectable formulation and process development. Hands-on experience with lyophilization, sterilization techniques, and aseptic manufacturing processes. Strong knowledge of GMP, ICH, and regulatory guidelines. Proficiency in using laboratory equipment such as autoclaves, lyophilizes, and HPLC systems. Excellent technical writing and documentation skills.