PURPOSE: A scientist to implement a series of assays into the development group in order to define and characterize the human mesenchymal stem cell (hMSC) product. This individual performs assays to assess changes in the biological properties of hMSC associated with changes in processing, passage of the cells, donors, contact inhibition, etc. The scientist will interact with staff from research, process development and quality control to insure smooth transfer of methods and data. Drafting and implementing required SOPs as well as qualifying the assays is a key element of this position.

GENERAL RESPONSIBILITIES:

Designs, executes, and analyzes experiments to characterize the cellular human mesenchymal stem cell product after processing using cell biology, molecular biology, and biopharmaceutical principles and techniques

Analyzes and summarizes data; prepares reports and presentations on the findings to team members and company staff

Prepares in a timely manner protocols, reports and other documents for transfer of assay methods, regulatory filings, and SOPs

Maintains scientific proficiency through the literature, attendance at scientific meetings and additional training

Searches out and acquires the skills necessary to develop assays essential to accomplish company and product development milestones

Manages time efficiently to meet milestones

Maintains laboratory notebook up to date and consistent with company policy

Interacts effectively with research, process development, quality control, regulatory, and manufacturing groups to understand the requirements of products in development in order to effectively move a high quality product to market

Attends and participates in Company seminars, including preparation and presentation of work as required

Contributes data and information essential for strategic development planning and product trending

Interacts with clinical and project teams to import and evaluate product concepts into the development strategy

Exports substantiated documents to clinical to support protocols and procedures

Understands quality guidelines and requirements as set forth by company policy

Other responsibilities as assigned

KNOWLEDGE AND SKILL REQUIREMENTS:

幌xperience in cell biology, cell culture and cell processing.
幌xperience in cellular, biochemical and molecular assay development.

幌xperience in methods of analysis using flow cytometry, ELISA, and molecular biology.

幌xcellent analytical skills and ability to thinking strategically.

幌xcellent oral and written skills

嫂ble to work independently and be a contributor as a team player.

EDUCATION AND EXPERIENCE:

PhD in cell biology, immunology, hematopoiesis or biochemistry with 5-10 years post doctoral experience, some of which is in the pharmaceutical industry

Experience in assay development using multiple techniques, e.g. flow cytometry, ELISA and RT-PCR

Experience in mammalian cell culture techniques and cellular characterization