Candidate will plan and execute independently assigned tasks such as method development, transfer and validation; provide analytical support to the research and development group to meet project goals; select appropriate methods and techniques in performing experiments; collaborate with senior personnel and/or manager to develop routine analytical methods; work cross functionally to achieve target goals; proactively seek out potential solutions to issues; attend project meeting to assure that all client analytical requirements are met; serve as a resource to other researchers involved in project.
Assure a positive transition of developed and validated methods to the quality control department personnel; conduct peer review and method approval. Candidate will also be responsible of creating method validation and/or qualification protocols and reports as well as analytical methods; perform all lab work that will support method validation, transfer, and qualification; perform qualification of primary and secondary reference material to be used as analytical standards.
Must have knowledge of ICH guidelines in method validation. Must understand the requirements for methodology transfer.
Requires a BS in Chemistry or related field, and at least 4 years experience in method development/validation/transfer, or an MS and at least 3 years of relevant experience in a cGMP environment; strong interpersonal and verbal communication skill; the ability to excel in a team-oriented environment and to use common tools for effective scientific communication within the company. Knowledge of the following instrument is required but not limited to: LC/UV/DAD/MS, FTIR, GC, GC/MS, NMR, and KF.