Job Summary/Description
We are seeking an experienced and innovative Laboratory Formulation Development Senior/Principal Scientist to join our Technology Transfer team. The successful candidate will lead formulation and process development projects, manage technology transfer activities, and ensure successful project execution. This role requires a deep understanding of pharmaceutical formulation development, project management expertise, and experience in technology transfer to cGMP manufacturing environment.
Key Responsibilities
- 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.
- Any other duties as assigned by supervisor.
Qualifications
Education:
- Senior Scientist: Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
- Principal Scientist: Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
Experience:
- Senior Scientist: 5 to 8 years of experience in pharmaceutical formulation development, including project management and technology transfer.
- Principal Scientist: > 10 years of experience in pharmaceutical formulation development, with significant experience in project management and technology transfer.
