The Analytical R&D laboratory supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. The department provides analytical services to manufacturing, Technical Services, Validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies.
- Ability to independently develop and validate instrumental methods in support of Drug Substances and Drug products
- Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences.
- Ability to make autonomous decisions in regards to day to day activities
- Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
- Preparation of reagents/standards/m?edias? needed for analysis according to established methods.
- Safe handling of potent and teratogenic compounds.
- Disposal of hazardous waste according to environmental regulations and company/departmental procedures.
- Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks.
- Capable of self-scheduling of work assignments.
- Assures right-first-time execution of departmental methods and SOPs.
- Facilitates and supports activities and services necessary to the routine operations of the department, as assigned.
- Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
- Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document.
- Lead all analytical method transfer activities as required by their area.
- Supports Material Evaluation Process for new materials
- Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers.
- Conducts and writes laboratory investigations using the appropriate Root Cause Analysis tools.
- Participates in inter-departmental task teams...cont.