Astellas Institute for 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.
We are seeking an Associate Director/Senior Scientist who will help to advance development of cell therapy products at AIRM. He/she will lead translational studies in 2-3 therapeutic programs aimed at biomarker discovery and donor cell engraftment.
Essential Job Responsibilities:
Lead studies in discovery of biomarkers that aid in identifying patients, understanding and characterizing treatment effects on the underlying pathobiology, and in safety monitoring
collaborates internally and externally to establish biomarker discovery and validation strategies, consults on clinical trial endpoints and their translation from/to preclinical model systems.
Efficiently collaborates with research and clinical scientists to implement sample collection and analysis in clinical and non-clinical studies and serves as in-house consultant on scientific and technical issues
Develops clinically applicable biomarker assays, working with internal scientists and contract organizations and contributes to assay validation
Designs and conducts non-clinical studies analyzes data, draws conclusions, makes suggestions based on results of experiments; writes study plans and technical reports, reviews study reports from collaborators and CROs
Demonstrates high level of independence in developing and executing research plans from hypothesis to conclusions, expert knowledge of cell biology principles and technical proficiency in research method
Stays current with scientific literature to proactively identify new objectives and approaches
Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in creative and practical ways
Demonstrates technical proficiency, scientific creativity, efficient collaboration with others, and independent thought
Communicates effectively with manager, internal and external stakeholders
Creates a positive work environment promoting teamwork, mutual respect, encouraging change, innovation, and accountability at all levels
Ensures data are of high quality and the projects are on time and within budget; maintains accurate records as notebook/batch record/electronic entries in compliance with the Company policy
May contribute to writing documents for regulatory submissions, scientific manuscripts, technical reports, SOPs, patent applications
Carries out work in compliance with Astellas Health and Safety policies
May manage one or more employees and take part in their annual goal writing and performance appraisal ensuring that employee development objectives are met.
May provide intellectual and technical support for other cross-functional projects
Required
BS, MS or Ph.D. degree in cell/molecular biology, or related scientific discipline with relevant post-degree laboratory research experience of 15+ years for BS, 10+ years for MS, or 8+ years for Ph.D. in a biotechnology/pharmaceutical industry or academic research.
Strong background in cell biology
Demonstrated experience in preclinical biomarker discovery/validation and translation into clinical trial setting
Working knowledge of statistical analysis software
Result orientation and ability to work in a high paced environment
proficiency in one or more of new high throughput platforms
Familiarity with queries on large biological datasets
Knowledge of applicable laboratory equipment including automation
Demonstrated ability to independently design research strategy and effectively implement experiments in a timely manner, to analyze data, draw conclusions, make scientific recommendations and troubleshoot
Excellent communication skills and demonstrated proficiency in writing technical and scientific reports, scientific manuscripts, preparing presentations
Proven ability to work both independently and collaboratively across a global matrixed organization
Ability to work flexible hours and weekends/holidays
Efficiency at managing multiple projects while working under tight timelines
Flexibility and willingness to tackle new challenges outside of their comfort zone
Result-oriented, self-starter, team player
Preferred
Background in regenerative medicine, immunology, ophthalmology
Experience in Biomarker Discovery workflow and implementation of program-based strategies
Familiarity with preclinical drug development, GLP/GMP environment
Working knowledge of omics data analysis, Next Generation Sequencing.
Proficiency with fit-for-purpose assay development.
Experience utilizing omics, flow cytometry, Nanostring, scRNA sequencing, molecular and/or cellular techniques to monitor disease activity and response to therapy
Working knowledge of statistical analysis tools
experience with pluripotent cells and their differentiated derivatives, and with different types of mammalian cells
expertise in biology of cell adhesion and extracellular matrix
Experience with writing SOPs, technology transfer, and training others
Demonstrated ability to establish and execute external collaborations with both academic laboratories and CROs
3+ years of industry experience
Category CMC Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans