Method Development and Validation Research Technician I

The Scientist I will support the Bioanalytical Method Development and Validation Team and is responsible for the overall scientific and operational management of client bioanalytical projects supporting a variety of studies simultaneously. This role requires knowledge of method validation principles and communication skills required to transfer methods to the analytical team.

Responsibilities

Support the Bioanalytical Method Development and Validation Team; Performs the development, validation, and transfer of immunoassays and bioanalytical methods (including but not limited to ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, and Elispot); With guidance, designs, plans, performs, and manages routine and non-routine projects; Assists in the evaluation of manufactured products and develops fit-for-purpose assays; Creates technical documents in the form of validation plans, test methods, worksheets, preparation sheets, and deviation reports; Compiles data and collaborates with the Scientific Director for project progression; Applies use of IT systems (ERP, LIMS) as required; Communicates project updates to internal team and external clients; Works effectively as a member of a team as well as independently; Assists in assay re-qualification as needed; Provides cross-functional support to other departments as needed; Adjusts work hours as needed to meet client deadlines; Understands and follows all procedures and processes required for work performed under Regulatory Compliance (e.g., GxP, FDA, GLP, GDP, GCP, OECD, and CLIA); Complies with internal and customer SOPs as required; Conducts all activities in a safe and efficient manner by adhering to site environmental health and safety (EHS) requirements

Requirements

B.A. or B.S. with minimum 3-4 years method development and validation experience; M.A. with minimum 2-3 years method development and validation experience; Ph.D. with minimum 0-1 year method development and validation experience; Experience in designing, validating, and/or performing immunoassays; Previous Pharma and/or CRO, Clinical Laboratory experience required; Ability to read, write, and interpret documents such as SOPs, technical reports, and method protocols; Authorization to work in the United States indefinitely without restriction or sponsorship

Nice to have

Good communication and interpersonal skills; Proven ability to compile data and create data reports; Computer proficiency in MS Word, Excel, and instrumentation software; Ability to perform statistical analysis and data interpretation; Ability to solve practical problems and troubleshoot assays; Ability to multitask with good time management; Organizational skills to manage and prioritize multiple projects effectively under little supervision; Proven ability to effectively communicate orally and in writing to coworkers, supervisors, and clients; Have a positive attitude and genuine interest in the drug discovery and development process and impact to patient health; Ability to work in a laboratory setting meeting the physical requirements of laboratory experiments

Benefits

Excellent full-time benefits including comprehensive medical coverage, dental, and vision options; Life and disability insurance; 401(k) with company match; Paid vacation and holidays