
Process Development Lab
6 days ago
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.
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