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 www.astellas.com .

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.

Astellas announces a Scientist II: Drug Product Development opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough MA . This individual will work with team to ensure that high quality clinical trial material is maintained, proactively mitigating potential risks and finding technical solutions for any issues that arise. In addition, the individual will plan and perform in vitro studies to demonstrate stability and integrity of cellular and gene drug products. Responsibilities will also include development and evaluate of delivery methodologies and devices. This position will collaborate closely with various departments including Process Science Technology, Analytical Development, Regulatory Affairs, cGMP Manufacturing, Quality Control, Quality Assurance, and Medical and Development, as well as outside CMO and/or other collaborators.

Essential Job Responsibilities:

Work team to ensure that high quality clinical trial material is maintained.

Conduct in vitro studies to demonstrate stability and integrity of cellular and gene cell products.

Develop and evaluate of delivery methodologies and devices.

Takes a leadership role in process and formulation development of cell based drug products.

Manage and implement planning and execution of incorporation appropriate processing materials, and equipment to suit regulatory requirements.

Direct/conduct studies, summarize the data and prepare study reports.

Collaborate with mechanical vendors to establish new processes.

Supervise and/or participate in production and technology transfer to CMO (Contracted Manufacturing Organization) and.or to other groups within and/or outside of the site.

Assist in writing CMC regulatory amendments and filings.

Cross functional collaboration with colleagues for process optimization leading to increased manufacturing efficiencies, quality, and yields of drug product.

Resolve technical and workflow issues in a timely fashion.

Initially, work will focus on ensuring drug product supply of drug product for on-going clinical trials. Successful completion of tasks will lead to industrial commercialization, which enables stable supply of drug product to the customer

Qualifications:

Required

Bachelors with 10+ yrs.; MS with 7 + yrs. or Ph.D. with 3+ yrs. experience in life sciences with experience in cell handling, aseptic processing, relevant techniques

Experience in process development of cell based drug product.

Ability to work well in multidisciplinary team, with strong communication skills and the ability to lead technology transfer activities and to pro-actively find solutions to issues

Flexible schedule, with the possibility of occasional weekend work.

Preferred

3+ years of industrial experiences of process development of cell product

2+ years of experience in GMP/GLP environment.

Working knowledge of ocular cells and surgical delivery devices.

Experience in development of parenteral drug product such as formulation development and aseptic filling (or auto-filling) process.

Experiences of PV (Process Validation) or PPQ (Process Performance Qualification) of drug product.

Category CMC Technical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans