Shire Regenerative Medicine is a rapidly growing, world-class organization specializing in cell therapies led by the Company’s approved product Dermagraft®. The Company is seeking an individual with research and development experience conducting cell-based assays and performing microscopic evaluation. The candidate will play an important role in executing a science-driven strategy to support Dermagraft process improvements and product characterization, and to provide support for expanding and strengthening the non-clinical package in support of existing and future products. This position will be based in San Diego CA.|
- Conducts conventional and confocal microscopic analyses to support company product characterization and nonclinical/clinical tissue specimens using methodologies to include immunohistochemical, in situ hybridization and conventional staining with quantification of outcomes.
- Conduct mammalian cell-based research studies and provide image analysis support for evaluation of company product mechanism of action and new product characterization.
- Manage purchasing of supplies and research reagent as well as overseeing research laboratory equipment maintenance, calibration and services to ensure continuous laboratory operations.
- Organize and maintain searchable inventories of research materials, chemicals MSDS’s and cell banks for use by laboratory personnel and review by outside agencies..
- Draft reports summarizing in-house preclinical laboratory studies; draft study protocols, test procedures and standard operating procedures related to preclinical laboratory research efforts; communicate team progress both in oral and written formats at weekly research meetings.
- Manage laboratory interns.
Education and Experience Requirements:
Bachelor’s degree (B.S.) or equivalent with 4+ years or Master’s degree (M.S.) with 2+ years related experience and/or training in the area of cell biology or similar biological discipline with an emphasis on microscopic analysis. Direct experience in the development of human therapeutics at a biotechnology or medical device company is desirable. Must have strong microscopy skills; experience with confocal imaging is preferred. Hands on experience with mammalian cell culture, including primary cell culture is essential. Familiarity with conducting standard laboratory techniques such as ELISA, MTT, DNA assays and PCR is preferred.
Other job requirements:
- Experience with IHC, Fluorescence, in situ hybridization based microscopic analysis
- Experience in confocal microscopy
- Experience with image analysis software such as CellSens Dimensions and MetaMorph
- Laboratory experience in cell culture, cell biology and cryopreservation
- Experience performing cell-based and plate-based assays including ELISA
- Experience in managing normal laboratory operations including maintenance and calibration of equipment waste management and purchasing
- Experience creating, organizing and maintaining searchable inventories for frozen cell banks, chemicals, MSDS and experimental materials
- Ability to implement good documentation practices for all research study data in laboratory notebooks, study binders, draft study protocols, test procedures and standard operating procedures related to preclinical laboratory research efforts
This individual may be required to travel up to 5% of the time to interact with outside laboratories in support of the Company’s objectives. The individual may be required to be capable of lifting items weighing up to 30 lbs.
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