SUMMARY:
The Analytical Development Chemist will develop and validate analytical methods, provide analytical support for product development, and design, write, and execute technical documents such as protocols and reports. This role will serve as a subject matter expert for analytical methods and technical writing.
RESPONSIBILITIES:
- Responsible for development and validation of analytical methods (Assay, Impurities, Dissolution, Cleaning, and Residual Solvents).
- Designs, writes, and executes method validation protocols, reports, and other technical documents in accordance with current industry standards as well as regulatory requirements, i.e. FDA, USP, EP.
- Coordinate validation projects and ensure all validation documentation is finalized, current and archived as required.
- Oversee development of analytical services projects including formulations support to stability and validation.
- Must be able to understand and interpret data from formulation design to in-vitro/in-vivo performance and design experiments to support product development.
- Must be able to understand the purpose and objective of the studies to appropriately design laboratory experiments and protocols
- Coordinates analytical method transfer and training of testing with the Quality Control Laboratory and serves as a technical resource for investigations.
- All other tasks as requested or assigned.
QUALIFICATIONS AND REQUIREMENTS:
- Bachelor’s or master’s degree in chemistry or related field. PhD preferred.
- Experience: 3+ years required with advanced degree (research or work experience), prefer 5+ years’ work experience with BS degree experience in pharmaceutical analytical method development and validations.
- Experience in HPLC, Dissolution, UV-Vis, GC, Cleaning Validations, Empower, and compendial (USP, FCC, EP) testing preferred.
- Proficient in data analysis including raw data review and interpreting results.
- Strong writing and documentation skills (cGMP, protocols, reports, OOS investigations, lab notebooks)
- Proficient with Microsoft Office Suite (Word, Excel, Outlook)
- Familiar with using QMS systems (i.e., Empower, Master Control)
