KEY DUTIES AND RESPONSIBILITES:
· Formulation Development Leadership: Lead the design, development, and optimization of complex pharmaceutical formulations, ensuring they meet project objectives and regulatory requirements.
· Project Management: Oversee multiple formulation development projects, managing timelines, resources, and budgets. Ensure projects are completed on time and within scope.
· Technology Transfer: Manage technology transfer activities from R&D to manufacturing, ensuring seamless transition and scalability of processes.
· Experimental Design and Execution: Design and execute complex experiments to support formulation development, process optimization, and troubleshooting. Analyze and interpret data to draw meaningful conclusions.
· Technical Documentation: Prepare and review comprehensive technical documents, including formulation development reports, batch records, technology transfer documents, and regulatory submission documents.
· Collaboration: Work closely with cross-functional teams, including Analytical Development, Quality Assurance, Quality Control Regulatory Affairs, Manufacturing, Engineering and Supply chain to drive project success.
· Compliance and Quality: Ensure all laboratory activities comply with regulatory guidelines, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), internal quality standards and safety policies.
· Innovation and Continuous Improvement: Stay abreast of industry trends, scientific advancements, and technological innovations to drive continuous improvement in formulation development practices.
· Mentorship: Mentor and guide junior scientists, fostering a collaborative and innovative work environment.
Education:
· Scientist: Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
Experience:
- Senior Scientist: 5 to 8 years of experience in pharmaceutical formulation development, including project management and technology transfer.
- 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).
Preferred Qualifications:
- Experience with advanced drug delivery systems (e.g., nanoparticles, liposomes).
- 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).
