Scientist I Analytical Development

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Scientist 1, Analytical Development
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
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 ****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 Scientist 1, Analytical Development
opportunity at their Astellas Institute of Regenerative Medicine (AIRM)
site in Westborough, MA.
Purpose:
Highly motivated and technically proficient individual to join our team and contribute to and advance the development of cell therapy products. This individual will develop and optimize a variety of analytical tests and collaborate closely within the team and across functional groups (R&D/QC) to advance multiple pipeline programs.
Essential Job Responsibilities:
Individually contributes to developing and optimizing analytical tests required for new product development and scale-up.
Demonstrates solid knowledge of cell biology principles and meticulous technical aptitude for analytical methods.
Develops strategy and technologies to perform experiments and analytical procedures, applying a variety of scientific principles.
Evaluates and defines analytical approaches to meet global regulatory guidelines.
Analyzes data, draws conclusions, writes technical reports and SOPs and makes suggestions based on results of experiments.
Coordinates research efforts and makes key technical contributions.
May lead the development of analytical tests, including identifying and applying innovative techniques and methodologies.
Maintains accurate records such as notebooks, batch records and SOPs.
Quantitative Dimensions:
This position interacts with multiple functional groups and levels of management. Actions have direct impact on analytical and process development with indirect implications on manufacturing operations.
Organizational Context:
Reports to Analytical Development Sr. Scientist or Associate Director, Department of Technical Operations
Requirements
Qualifications:
Required:
BS with 8 , MS with 6 or PhD with 0-3 years of relevent industry experience.
Ability to work independently as well as part of a team
Self-reliant, self-motivated, detail-oriented, highly organized
Willingness and ability to learn new skills
Four or more years' experience with aseptic tissue culture technique
Working knowledge of molecular and cell biology analytical methods, such as flow cytometry, ELISA, qPCR, ddPCR
Capable of meticulous GDP record keeping
Excellent communication skills
Ability to plan experiments, analyze own data and write concise reports
Must be able to work flexible hours, including weekends
Preferred:
Prior industry experience, preferably CMC
Experience with pluripotent and/or immune cells expansion and analysis
Experience working under GLP/GMP
Knowledge of automated methods for cell analysis
Experience with assay qualification/validation and/or cell therapy products
Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance
Benefits:
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
#LI-LK
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type
Full-time
Location
MA, Westborough
Category
Research and Development

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