Analytical Scientist – ProMed Molded Products, Inc. – Plymouth, MN

Poon Position Description:

This individual will lead and perform a wide variety of analytical test method development, method validation, and routine testing activities for formulation and product release, including Quality Control related testing of incoming materials, commercial and R&D pharmaceutical dosage forms and medical device combination products to support formulation and product release activities.

Responsibilities:

• Lead the development and implementation of analytical test methods used in the formulation and ongoing production of molded pharmaceutical dosage forms and combination products
• Conduct routine and non-routine assay, content uniformity, and dissolution testing of experimental and commercial products using HPLC and related methods, including preparation of standards and test samples.
• Lead method transfers from customer and contract labs.
• Research and troubleshoot new test methods and improve/revise standard operating procedures and working practices.
• Perform statistical analysis of data against target specifications to evaluate present standards and achieve required quality and repeatability.
• Prepare reports suitable for internal use and reporting to customers
• QC Lab testing support of R&D and operations in resolving formulation and production issues.
• Participate in root cause investigations and present findings and possible corrective actions for out of specification QA/R&D test results.
• Lead and coordinate work with outside labs on non-routine chemical testing. Prepare test requests, review and approve results based on specifications.
• Perform analysis/justification for equipment and other technology purchases including equipment onboarding with authoring and execution of IQ/OQ/PQ as needed.
• Coordinate and review work of junior analytical scientists, providing mentoring and training where needed

Qualifications (or will train):

• Advanced Degree in Chemistry or related discipline with 3-5 years of experience or Bachelor’s degree with a minimum of 8-10 years experience, preferably in the medical device or pharmaceutical field.
• High level of experience in performing HPLC analysis. Proficiency in, UV/Vis, FTIR, and KF instrumentation related lab testing.
• Experience in performing analytical chemistry and material properties-related testing in a fast-paced laboratory setting.
• Experience in writing SOPs and validation plans.
• Proficiency with PCs, Microsoft Excel, Word, Access, and Project and quality tools.
• Possess good oral and written communication, critical thinking and problem-solving skills.
• Experience with sampling and sample preparation techniques and awareness of FDA requirements such as 21 CFR 210 and 211. ISO 13485 (current) standards.
• Experience with Good Laboratory Practices
• Flexible team player with ability to prioritize work and function in a small company environment.
• Familiarity with lean and six sigma methodologies and DMAIC problem solving thought processes.
• Must be a US citizen or authorized to work in the US.