The Scientist II 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 analytical team. The Scientist II role supports client projects with limited supervision and requires project leadership and direct client communication.
Research Technician II Duties Include but are not Limited to the Following:
- Works effectively as a member of a team, under minimum direction, to achieve client and business deadlines
- Understands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and attends annual GLP training
- Assists the development, validation and transfer of immunoassays and bioanalytical methods with limited direct supervision (RIA, EIA, Flow Cytometry, Cell-Based Assays)
- Provides contracted method development and validation services consistently with delivery on time and high quality.
- Characterizes antibodies and performs reagent qualification as applicable
- Conducts evaluation of manufactured products and develops fit-for-purpose assays
- Communicates project updates to internal and external clients with limited supervision
- Provides technical documentation in the form of validation plans, reports, deviation reports, test methods and tables with limited supervision
- Reviews validation data, validation plans and reports and provides technical leadership and constructive feedback to team members
- Has the ability to organize daily workflow of the development and validation schedule in lab and consistently meets validation timelines.
- Ability to develop a method with assistance from Scientific Director
- Provides technical leadership, mentoring and training to junior staff
- Provides troubleshooting, root cause analysis and assistance with method design
- Complies with internal and customer SOP’s as required in training program; maintains an up to date training file
- Applies use of IT systems (ERP, LIMS, etc.) as required
- With minimum guidance, designs, plans and performs/manages routine and non-routine projects
- Applies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position
- Owns the accountability and responsibility for delivering to client needs and timelines
- Provides cross-functional support to other departments as required
- Adjusts work hours as needed to meet client deadlines
- Adheres to site environmental health and safety (EHS) requirements
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Performs other duties as assigned