Manager of Assay Development
Scope of Function:
1) Assist in the Development and execution of relevant biochemical and biological assays
2) Assist in leading in the resolution of technical problems and training of personnel in the Process Development and Quality Control Group
3) Assist in the transfer of assays to the Quality Control Group.
1) Assist in the development and perform final product and in-process assays as required such as ELISA, SDS PAGE, IEF, HPLC, WESTERN, BCA, and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards.
2) Record development activities and results in appropriate notebooks.
3) Assist in the preparation and execution of design input, design output and development reports for newly developed assays.
4) Assist in the preparation of SOPs and train Quality Control group on newly developed assay processes.
5) Assist in leading the coordination of activities and communication to assure efficient and timely transfer of projects to the Quality Control
6) Assist Quality Control Group in trouble shooting assays where appropriate
7) Effectively interact and assist other groups within the Development group and the Quality and Regulatory groups on assay related matters.
8) Participate in other projects in the Process Development group
9) Maintain laboratory inventories and equipment.
10) Assist in communicating project status with Clients, Project Management and Senior GBI Management as needed.
11) Multi-task multiple projects
Education and Skills required:
Education: BSc or MSc biological or biochemical sciences.
Experience: 1 Â
- 3 years relevant laboratory experience in assay development and characterization, particularly in the areas of immunology and protein chemistry. Experience in assay qualification, validation and compliance is a plus.
Skills: This individual must be able to work semi-independently with some direction. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Good communication, documentation and computer skills
Quality Assurance, Quality Control, and Process Development Scientists.