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.
- 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.
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