POSITION SUMMARY

The Analytical Scientist performs a wide variety of analytical test method development, method validation, and routine testing activities for formulation and product releases. Including quality control related to testing of incoming materials, commercial, research and development pharmaceutical dosage forms and medical device combination products to support formulation and product release activities. The Analytical Scientist ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

• 
  Develops and implements analytical test methods used in the formulation and ongoing production of molded pharmaceutical dosage forms and combination products;
• Conducts routine and non-routine assay, content uniformity, and dissolution testing of experimental and commercial products using high-performance liquid chromatography (HPLC) and related methods, including preparation of standards and test samples;
• Performs method transfer customer and contract labs;
• Researches and trouble-shoots new test methods and improves/revises standard operating procedures and working practices;
• Performs statistical analysis of data against target specifications to evaluate present standards and achieves required quality and repeatability;
• Prepares reports suitable for internal use and reporting to customers;
• Provides Quality Control Lab testing support to the Research & Development and Operation teams in resolving formulation and production issues;
• Participates in root cause investigations and presents findings and possible corrective actions for out-of-specification Quality Assurance/Research & Development test results;
• Coordinates work with external labs on non-routine chemical testing; prepares test requests, reviews and approves results based on specifications;
• Performs peer review of analytical data;
• Meets expectations of regular, reliable attendance;
• Other Duties As Needed: Any other duties and tasks as deemed necessary and appropriate.

Qualifications:

• Minimum of a Bachelor’s degree with 0-3 years of experience, preferably in the medical device or pharmaceutical field.
• Experience in performing HPLC analysis using Empower is preferred. Proficiency in GC, UV/Vis, FTIR, DSC, and KF instrumentation desired.
• Experience in performing analytical chemistry and material properties-related testing in a fast-paced laboratory setting.
• Proficiency with PCs and Microsoft Office.
• Possess good oral and written communication, critical thinking and problem-solving skills.
• Experience with sampling and sample preparation techniques.
• Awareness of FDA requirements such as 21 CFR 210 and 211. ISO 13485 (current) standards.
• Flexible team player with ability to prioritize work and function in a small company environment.