I thought I'd print this job listing from little over a month ago. There were 6 or 7 jobs at Cognate advertised back then.
Process Development/Assay Scientist
About the Job
A company specializing in high level contract services management and biotechnology support to emerging companies in the field of cellular and biological therapeutics is seeking a team oriented individual to work in the Process/Assay Development area of the organization’s Baltimore area facility. This position offers broad exposure to and involvement in cell therapy process development and cell, biochemical and molecular-based assay development in support of client projects. This position will also involve participation in technology transfer and other scientific collaboration activities between the Company and its clients. The individual will be expected to work independently, actively participate in team oriented agendas and in some cases lead teams for certain objective based projects.
Typical work activities of the group:
-Devising new processes, or refining existing ones, to optimize manufacturing processes;
-Devising new assays, or refining existing ones, for release, comparability and qualification Manufacturing processes and products;
-Planning, carrying out and supervising trial manufacturing runs in laboratories, and initial training of manufacturing staff and Quality Control staff in core facility;
-Scaling up the production process via trial runs, making changes to raw materials or components and process parameters to ensure quality is maintained during large-scale production;
-Improving yields by reducing costs, for example investigating alternative materials or new machinery to improve efficiency, quality and yields in bottleneck areas;
-Developing and implementing process controls and devising test methods to assess the production process;
-Initiating assay validations
-Working with client products at various stages of clinical development;
-Developing formulae, specifications and label declarations, and ensuring compliance with the finished product specifications;
-Advising on material and equipment modification to enable process changes for new product development;
-Reading and writing technical reports and specifications, and maintaining appropriate records;
-Initiating and generating ideas based on reading and research.
-Devising methods for making products at the required scale and/or evaluating existing processes to identify areas for improvement;
-Formulating and establishing product design and performance objectives, normally in consultation with other functions, including research, marketing and production, as well as contractors, suppliers and customers;
-Responding to customer requirements, liaising with suppliers of raw materials and resolving production problems;
-Conducting test protocols and procedures, and product evaluation;
-Transferring new technologies across a range of product categories;
-Writing technical reports and cost estimates, documenting development work and implementing profit improvement programs;
-Generating data to substantiate claims regarding the safety and efficacy of new products (this applies particularly to the pharmaceutical and healthcare sector); and
-Participating in the oversight, development and the integration of new product offerings, including but not limited to supporting brand development, sales strategy, quality assurance, marketing and manufacturing.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
