Job Title: Scientist II - Analytical Development
Location: Fort Lauderdale, Florida
Job Description: We are seeking a highly skilled Scientist II to join our Analytical Development team in Fort Lauderdale, Florida. The ideal candidate will hold a minimum of a Master's degree in Chemistry, Biochemistry, or Analytical Chemistry coupled with at least 5 years of industry experience. This position offers an exciting opportunity to contribute to the development and validation of analytical and bioanalytical methods in a dynamic and collaborative environment.
Responsibilities:
- Qualify and develop analytical and bioanalytical test methods and assays with minimal supervision.
- Design and execute experiments to support the development, optimization, and validation of analytical methods for drug substances, drug products, and intermediates.
- Analyze and interpret experimental data, troubleshoot technical issues, and propose innovative solutions.
- Write and review Standard Operating Procedures (SOPs), protocols, reports, and method transfer documents in compliance with regulatory guidelines and internal quality standards.
- Collaborate effectively with cross-functional teams including Research and Development, Quality Assurance, and Regulatory Affairs to support project timelines and deliverables.
- Maintain accurate and detailed laboratory notebooks and documentation to ensure data integrity and traceability.
- Stay current with advances in analytical techniques, instrumentation, and industry best practices through literature review and attendance at scientific conferences.
- Participate in laboratory equipment qualification, calibration, and maintenance activities as needed.
Qualifications:
- Master's degree or higher in Chemistry, Biochemistry, or Analytical Chemistry.
- Minimum of 5 years of relevant industry experience in analytical method development and validation.
- Proficiency in a wide range of analytical techniques such as HPLC, LC-MS, GC, FTIR, UV-Vis spectroscopy, and dissolution testing.
- Strong understanding of regulatory requirements (e.g., FDA, ICH, USP) for analytical method validation and documentation.
- Excellent written and verbal communication skills, with the ability to effectively present scientific data and findings to internal and external stakeholders.
- Detail-oriented with strong organizational and time-management skills.
- Proven ability to work independently as well as part of a multidisciplinary team in a fast-paced environment.
- Experience with bioanalytical method development and validation is desirable but not required.
