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Pharmaceutical Research Scientist
2 months ago
Job Summary:
Aucta Pharmaceuticals is seeking a highly skilled Chemical Development Specialist to join our team. As a key member of our research and development department, you will be responsible for performing pharmaceutical development in pre-formulation, formulation development, stability studies, method development and validation, and CMC (Chemistry, Manufacturing, and Controls).
Responsibilities:
- Develop and implement pre-formulation and formulation strategies to support the development of new pharmaceutical products.
- Design and execute stability studies to ensure the long-term stability of pharmaceutical products.
- Develop and validate analytical methods to support the quality control of pharmaceutical products.
- Collaborate with cross-functional teams to ensure compliance with cGMP/GLP regulations and guidelines.
- Develop and maintain technical documents, including CMC sections for regulatory submissions.
Requirements:
- Master's degree in Chemistry, Biochemistry, Bioengineering, or Biotechnology.
- Strong knowledge of CMC, analytical chemistry, cGMP/GLP compliance, HPLC, method development and validation, and regulatory submissions (NDAs and ANDAs).
- Excellent communication and collaboration skills.
What We Offer:
Aucta Pharmaceuticals offers a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.