Scientist II, Analytical Development - Late Stage

Role Summary

This position is responsible for developing analytical tests and characterization methods for pharmaceutical formulation, process, and specification development for late-stage projects. The Scientist II, Analytical Development will work with formulation scientists to develop various therapeutic drug formulations using Xeri Sol and Xeri Ject technologies, and will support Quality Control and CMC in establishing product specifications, stability programs, material qualification, method validation, and process validation.

• Develop specific and selective chromatographic methods (HPLC, UHPLC, LCMS) for characterizing prototype pharmaceutical formulations. Methods, where applicable, should be compatible with mass selective/mass spectroscopic detection.
• Develop or source other methods (e.g., NMR, particle analysis, etc.) required for supporting formulation development, stability, product quality and characterization.
• Direct the design requirements/capabilities of new technologies required to support new product testing.
• Collaborate with QC to transfer methods for late-stage clinical support and registration batches.
• Keep current with relevant literature and industry standards as applicable to research areas.
• Oversee the implementation of compendial monographs and procedures (USP, EP, etc.).
• Perform the duties as required for Reference Standard programs, instrument maintenance/ calibration and Stability Programs (internal and external).
• Configure and operate laboratory instruments, including HPLC, LCMS, Karl Fischer Titrator, etc.
• Read and record instrument data, tabulate data, and keep detailed laboratory records.
• Draft Standard Operating Procedures (SOP’s) for advanced laboratory equipment (HPLC/UHPLC-MS) operation and maintenance.
• Manage external contract laboratories for methods development/characterization.
• Assume a lead SME role in analytical chemistry-related team roles and responsibilities (internal and external projects).
• Write development reports for internal reference, relevant sections of IND, NDA, BLA and other regulatory documentation.

• A graduate degree in analytical chemistry (M.S. or Ph.D.) with a minimum of 3-5 years of relevant industrial pharmaceutical experience. A Ph.D. with relevant academic research experience may substitute for some industrial experience. Alternatively, a B.S. in Chemistry with 5-10 years of method development experience in an industrial pharmaceutical laboratory.
• Demonstrate understanding of modern chromatographic methods and theory, especially the chromatographic methods used for the characterization of drug products.
• Demonstrated experience and technical expertise in functional testing methods for combination products
• Prior experience and expertise in microbiological methods, including review and troubleshooting of microbiological results
• Hands-on experience and expertise with Mass Spectroscopic detectors coupled with HPLC or UHPLC.
• Ability to work independently as well as in a team.
• Prior experience with successful regulatory submissions (IND/NDA/BLA) and commercial method support a strong positive
• Ability to draft routine reports and maintain accurate and detailed records of work performed.
• Working knowledge of Microsoft Productivity software (Excel, Word, etc), Agilent Chem Station, and common statistical software like JMP and Minitab.
• Competencies :
  Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications

• Must be able to stand for extended periods of time.
• Must be able to lift 25 lbs. or more.
• Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays, etc., and perform visual inspection for defects.
• Position works with potentially hazardous chemicals and active pharmaceutical ingredients. May require periodic evening and weekend work, as necessary to meet company deadlines.
• Position may include periodic travel (domestic and international).
• On-site at the Chicago office; five days per week (Monday through Friday) on-site is required.