Manager/Sr Scientist Assay Development - Aligned Resources

Position Description

Reports to the Sr. Director of Process Development

Scope of Function:
1) Develop and perform relevant biochemical and biological assays
2) Lead the resolution of technical problems and training of personnel in the Process Development and Quality Control Groups
3) Responsible for the transfer of assays to the Quality Control Group.
4) Effectively manage the Assay Development group.

Position Responsibilities:
1) Develop 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) Recording development activities and results in appropriate notebooks.
3) Write and execute design input and design output reports, SOPs, and batch records for newly implemented assays.
4) Write SOPs and Batch records for newly implemented assay processes.
5) Lead 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 were appropriate
7) Effectively interact and assist other groups within the Development group and the Quality and Regulatory groups on assay related matters
8) Interact with Clients and make recommendations and resolutions of assay being developed
9) Maintain laboratory inventories and equipment
10) Communicate project status with Clients, Project Management and Senior Management as needed
11) Effectively manage and motivate lab associates in the assay development group
12) Multi-task multiple projects
13) Evaluation and estimation of Technical aspects of assays to Sales and Marketing group for the generation of project proposals and quotes for new and existing clients

Position Requirements:
1) MSc or PhD in biological or biochemical sciences.
2) 5 – 10 years relevant laboratory experience in assay development and characterization, particularly in the areas of immunology, molecular and cell biology and protein chemistry. Experience in assay qualification, validation and compliance is required.
3) Considered an expert in the area of assay development and therefore must be able to work independently with little to no direction. Must be flexible and able to work on multiple projects simultaneously. 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

How to Apply

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