Job Summary:
We are seeking an experienced and highly skilled Laboratory Analytical Development Senior/Principal Scientist to join our Technology Transfer team. The successful candidate will lead analytical method development projects, manage method transfer activities, and ensure successful project execution. This role requires deep expertise in analytical development, project management skills, and extensive experience in method transfer to manufacturing.
Key Responsibilities:
- ALead the development, optimization, and validation of complex analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
- Oversee multiple analytical development projects, managing timelines, resources, and budgets to ensure timely and successful completion.
- Manage method transfer activities from R&D to Quality Control and manufacturing, ensuring smooth and effective transfer of validated methods.
- Design and execute complex experiments to support analytical method development, validation, and troubleshooting. Analyze and interpret data to draw meaningful conclusions.
- Prepare and review comprehensive technical documents, including method development reports, validation protocols, method transfer documents, and regulatory submission documents.
- Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to drive project success.
- Ensure all laboratory activities comply with regulatory guidelines, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and internal quality standards.
- Stay abreast of industry trends, scientific advancements, and technological innovations to drive continuous improvement in analytical development practices.
- Mentor and guide junior scientists, fostering a collaborative and innovative work environment.
- Any other duties as assigned by supervisor.
Education & Qualifications:
- Master’s or Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field.
- Preferred have experience with advanced analytical techniques (e.g., mass spectrometry, NMR).
- Preferred have knowledge of statistical tools and software for data analysis (e.g., Empower, ChemStation, Minitab).
- Prior experience in preparing regulatory submission documents (e.g., IND, NDA, ANDA).
Experience:
- Senior Scientist: 5 to 8 years of experience in analytical method development in the pharmaceutical industry, including project management and method transfer.
- Principal Scientist: > 10 years of experience in analytical method development in the pharmaceutical industry, with significant experience in project management and method transfer.
