Job Summary:
We are seeking a highly motivated and skilled Laboratory Formulation Development Associate Scientist/Scientist to join our dynamic Technology Transfer team. The successful candidate will play a key role in the formulation and process development of pharmaceutical products, contributing to the innovation and improvement of drug delivery systems. This position involves hands-on laboratory work, including the design, development, and optimization of pharmaceutical formulations, as well as analytical method development and validation.
Key Responsibilities:
- Design and develop innovative pharmaceutical formulations (solid, liquid, semi-solid, etc.) in accordance with project objectives and timelines.
- Optimize and scale-up formulation processes from lab-scale to pilot and commercial-scale manufacturing.
- Plan, execute, and analyze experiments to support formulation development and process optimization, ensuring reproducibility and robustness of results.
- Prepare and review technical documents, including formulation protocols, batch records, development reports, and regulatory submission documents.
- Work closely with cross-functional teams, including Analytical Development, Quality Assurance, Regulatory Affairs, Manufacturing, Engineering and Supply chain to ensure project success.
- Ensure all laboratory activities comply with regulatory requirements, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
- Stay current with industry trends, scientific literature, and technological advancements to drive innovation in formulation development.
- Troubleshoot and resolve technical issues related to formulation and process development.
- Any other duties as assigned by supervisor.
Educations and qualifications:
- Bachelor’s degree/ Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
- 2- 5 years of experience in pharmaceutical formulation development or related field.
Technical Skills
- Hands-on experience with formulation and process development for various dosage forms (e.g., tablets, capsules, injectables, topical formulations).
- Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and microscopy.
- Familiarity with regulatory guidelines (e.g., FDA, EMA) and quality systems (e.g., GLP, GMP).
- Prefer have experience with advanced drug delivery systems (e.g., nanoparticles, liposomes)
- Prefer have knowledge of statistical tools and software for experimental design and data analysis (e.g., Design of Experiments (DOE), Minitab, JMP).
- Previous experience in preparing regulatory submission documents (e.g., IND, NDA, ANDA).
Working Conditions:
- This position involves working in a laboratory setting with potential exposure to chemicals and biological materials.
- Must adhere to safety protocols and wear appropriate personal protective equipment (PPE).
