Scientist , Analytical Development

Overview

This position is responsible for the development of analytical and characterization methods for a range of pharmaceutical dosage forms in support of formulation, process, and specification development. The Scientist I, Analytical Development will work collaboratively with product development scientists seeking to develop various therapeutic drug product formulations incorporating the company’s Xeri Sol and Xeri Ject technologies. This role will also support Quality Control and CMC with respect to establishing product specifications, stability programs, material qualification, method validation, method transfer and process validation.

• Develop specific and selective chromatographic methods (HPLC, UHPLC, LCMS) for use in characterizing prototype pharmaceutical formulations. Methods, where applicable, should be compatible with mass selective/mass spectroscopic detection.
• Collaborate with formulation and other analytical scientists in the product development function to design adequate stability for drug products.
• Configure and operate laboratory instruments, including HPLC, LCMS, Particle size analyzer, Karl Fischer Titrator, etc.
• Direct the design requirements/capabilities of new technologies required to support new product testing.
• 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).
• 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/method transfer/QC testing.
• 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 and other regulatory documentation.
• Adhere to department budgets

• A graduate degree in analytical chemistry (M.S. or Ph.D.) with a minimum of 1-3 years of relevant industrial pharmaceutical experience is preferred. A Ph.D. with relevant academic research experience may substitute for some industrial experience. Alternatively, a B.S. with 3-5 years of method development experience in an industrial pharmaceutical laboratory will be considered.
• Understanding of method development, method validation and transfer principles in a GMP setting.
• Hands‑on experience and expertise with Mass Spectroscopic detectors coupled with HPLC or UHPLC.
• Demonstrate understanding of modern chromatographic and theory, especially the chromatographic methods and theory for proteins and Biologics.
• Experience with GMP/GLP environments and understanding of FDA and ICH guidelines.
• Working knowledge of laboratory information management systems (LIMS) and document management systems.
• Ability to work independently as well as in a team.
• Prior knowledge of successful regulatory submissions (IND/NDA/BLA) and commercial method support is a plus.
• 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.
• Competencies
  :
  Teamwork & Collaboration, Attention to Detail, Self‑Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications
• Working Conditions
  :
  • 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).
  • This position is based in Xeris’ Chicago office and…