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Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc 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.
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 Massachusetts.
Astellas is announcing a Dir of Cytogenomics opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
Astellas Institute for Regenerative Medicine (AIRM), a cell based therapeutic company, is seeking a highly motivated Molecular Geneticist/ Cytogeneticist to lead a fully functional GMP cytogenomics laboratory for all cell based products produced at the Astellas Institute for Regenerative Medicine. The position also calls for strategic development and implementation of new technologies to achieve desired screening and testing goals. The cornerstone of product safety is the ability to properly process and analyze cell therapy products for genetic stability
Essential Job Responsibilities:
* A focus on and expertise in molecular genetics and assay development and design across standard and novel testing platforms to establish working SOPs where appropriate
* Review and implementation of Standard Operating Procedures (SOP) for purposes of chromosome and FISH analysis as well as other molecular cytogenetic techniques on all cell based products
* Validation of all procedures in alignment with Standards and Guidelines for Clinical Genetics Laboratories with respective assay cutoff values in line with the development of cellular medicines
* Supervise the training of Analysts in performance of SOPs for standard procedures as well as new methods
* Manage analysis of Karyotype and FISH images on all manufactured cell products for chromosomal abnormalities and assess any potential safety impact based on these results
* In conjunction with the Quality Assurance unit, initiate Out of Specification Investigations based on abnormal findings
* Review of final reports after completion of analysis
* Other duties as they arise with regard to administration and strategic planning and acting as SME in certain capacities
* Work cross functionally within Astellas and with CROs
* Experience with budgets and planning
* Direct impact to the design and costing of a cytogenomics function within a QMS and as a technology development engine
* Management and design of experimental and technologiocal strategies and the incorporation of these technologies into practice.
* Reports to the Executive Director of Technical Operations in Westborough, Massachusetts.
* Oversees all genomic testing for all products manufactured at Astellas Institute for Regenerative Medicine
* PhD or equivalent
* Experience in Clinical Genetics and/or Molecular Genetics
* 10 years of relevant experience is preferred, with 5+ years experience in molecular genomics or similar
* Track record of successfully working cross-functionally to achieve organizational goals
* Operations experience with a variety of clinical and experimental assays or assay systems in cell therapy/regenerative medicine.
* Knowledge of US and EU cytogenetics regulations as they apply to cell therapy and regenerative medicine would be a plus
* Knowledge of assay qualification methodologies within a cell therapy/regenerative medicine environment
* Board certification in molecular cytogenetics is favorable but not a prerequisite for the position
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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