Astellas Pharma Sr. Manager of Cytogenetics in Marlborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
Purpose & Scope:
Astellas Institute for Regenerative Medicine (AIRM), a cell based therapeutic company, is seeking a highly motivated Board Certified/Board Eligible Clinical Cytogeneticist to establish a fully functional cytogenetics laboratory for all cell based products produced at AIRM. The cornerstone of cell based therapies safety, is the ability to properly process and analyze chromosomes in order to detect and interpret any chromosomal abnormalities.
Essential Job Responsibilities:
- Writing and implementation of Standard Operating Procedures (SOP) for purposes of karyotype and FISH analysis on all cell based products
- Purchase of all necessary equipment and reagents to perform FISH/Karyotype assays
- Establish maintenance schedule of all equipment with ability to troubleshoot equipment if necessary
- Validation of all probes for FISH analysis in accordance with Standards and Guidelines for Clinical Genetics Laboratories and their respective cutoff values
- Initially, Individual must be capable of performing assay development at the bench level to establish working SOPs for each cell product.
- Training of Quality Control Analysts in performance of SOPs
- Analyze Karyotype and FISH images on all manufactured cell products for chromosomal abnormalities and access any safety issues based on these results
- In conjunction with the Quality Assurance unit initiate Out of Specification Investigation based abnormal findings
- Initiate final reports after completion of analysis
- MD, PhD or equivalent
- Satisfactory completion of full-time training in an ABMGG-accredited, 2-year laboratory genetics postdoctoral training program in one of the clinical laboratory specialties (Clinical Cytogenetics and Genomics and or Clinical Molecular Genetics and Genomics preferred)
- ABMG Board eligible or certified
- 1-5 years of experience is preferred
- Operations experience of Spectral Karyotyping (SKY) in cell therapy/regenerative medicine.
- Knowledge of US and EU cytogenetics regulations as they apply to cell therapy and regenerative medicine.
- Validation experience with cytogenetics assays for cell therapy/regenerative medicine.
The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Research and Development