- Plans and executes experiments supporting development activities and project goals.
- Selects appropriate analytical methods and techniques to support process development.
- Troubleshoots analytical methods and lab instrumentations.
- General maintenance of Analytical laboratory for Small Molecules
- Performs physical and chemical characterization of drug substances and drug products.
- Process and interprets data.
- Collaborates with supervisory personnel to develop methods.
- Perform data analysis and evaluate quality of data.
- Develops subject matter expertise in an analytical technique and acts as a resource for other employees within the department.
- Coordinates and monitors specific method development activities or studies within a larger project.
- Authors reports, protocols, test methods, and other documentation.
- Perform technical review of release and stability data (including raw test data) to ensure compliance with all established and approved analytical procedures.
- Review results transcribed to data tables, protocols, and reports to ensure accuracy.
- None
- BS/BA degree in Analytical Chemistry or related Sciences and a minimum of seven years of related experience; or,
- MS/MA degree in Analytical Chemistry or related Sciences and a minimum of five years of related experience; or,
- PhD degree in Analytical Chemistry or related Sciences and zero or more years of related experience; or,
- Equivalent combination of education and experience.
- 7-10 years of related experience and/or combination of experience and education/training.
- Hands-on proficiency and problem-solving skills with HPLC/UPLC, LC-MS, ICP-MS/IPC-OES, GC, FTIR, KF and dissolution or other analytical techniques.
- Knowledgeable in DSC, DVS, PSD and XRPD techniques is a plus.
- Experience reviewing raw data and documents generated in an analytical test laboratory is preferred.
- Technical hands-on laboratory experience in Small Molecules and solid oral dosage is preferred.
- Good investigative skills and ability to troubleshoot methods.
- Experience with Instrumentation software such as Empower, ChemStation, etc.
- Proven ability to manage multiple assignments and effectively complete all expected deliverables in a timely manner.
- Knowledge of Good Manufacturing Practices and FDA/ICH and EU regulations and guidelines.
- Extensive knowledge of varying stages of development such as analytical technology transfer, analytical support for process validation, ICH stability, specifications, etc. is highly desirable.
- Ability to communicate clearly and effectively, both verbally and in writing.
- Must have strong organizational skills and be detail oriented.
- Demonstrate ability to take initiative and work independently.
- Capability to work within a team and as an individual contributor in a fast-paced environment.
- Experience with Microsoft Office (Word, Excel, Power Point, etc.).
- Environment: primarily working in laboratories or in office.
- Travel may not be required.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.