About This Role
This mid-level analytical scientist opportunity supports the analytical development of pharmaceutical oral dosage forms. The individual will fulfill a critical role in supporting the analytical development, validation/verification, and method transfer of testing methods for the Quality Control laboratory, characterizing drug substance, raw materials, and drug products. This role is part of the Quality Control Technical Services (QCTS) team, which performs release testing of API, excipients/raw materials, in-process and finished products, stability studies, and cleaning verification samples.
Responsibilities
- Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specifications, and company policies as identified in standard operating procedures (SOPs)
- Comply with cGMPs, SOPs, and STPs to avoid out-of-specification situations and assure compliance with state and federal regulations
- Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution
- Calibrate HPLC, dissolution apparatus equipped with auto-sampler and/or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator
- Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients, and dosage forms to be used in the analytical laboratory for routine analysis
- Develop and optimize new and existing analytical methods for qualification and release testing of products
- Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities
- Expand analytical capabilities of the Analytical Group
- Document steps followed during analysis execution, calculate and report results
- Actively participate in investigation of laboratory results
- Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies
- Provide timely responses to internal and external inquiries
- Evaluate, recommend, and implement new analytical technologies and instrumentation for testing
- Stay abreast of new developments in analytical technologies
- Contribute to improvement in laboratory operations to increase efficiency and GMP compliance
- Lead team members on assigned projects, as required
- Participate and lead scientific discussions on projects with cross-functional teams
- Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory
