Scientist Biopharma Manufacturing Quality Control Analyst I Analytical MA-TC at Astellas

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 is announcing a Technical Biopharma Manufacturing Scientist I opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. This is an onsite position.

Purpose and Scope:

The successful candidate will work closely with Process Development, Manufacturing, Engineering and Quality Assurance teams to ensure successful introduction of new processes (NPI) & new technologies from internal and external partners to GMP manufacturing department.  The incumbent will focus on evaluation of manufacturing processes, gap analysis of material/equipment/systems between the sending and receiving units, and training of MFG associates of process-related techniques and use of new equipment.  The incumbent will also provide GMP Technical Training during new employee on-boarding process to ensure operation proficiency and compliance. The candidate will work with other team members to develop/execute training programs and evaluate training effectiveness. 

Essential Job Responsibilities:

• Support or lead new process or technology transfer from internal and external partners into GMP manufacturing department including documenting tech transfer progress and authoring technical reports
• Identify and evaluate criterial process parameters, assess underlying technical challenges, and define the best approaches to achieve suitable processes for cGMP manufacturing.
• Develop and provide process-related training to MFG personnel and author training reports during tech transfer.
• Develop and execute MFG new employee GMP technical training program in alignment with techniques of upcoming NPI programs.
• Support manufacturing department including supporting MBR development and review, trending key process parameters across manufacturing batches.
• May perform stem cell culture and differentiation, process optimization and/or scale up to improve GMP production efficiency.
• Perform other duties as assigned.

Quantitative Dimensions:

• This role will ensure the delivery of GLP and GMP material by ensuring manufacturing systems and practices are consistent, follow AGT/MA-TC policies and procedures, regulatory requirements, guidelines, and recommendations. This role will seek out, initiate, and lead process improvements, and under direction of management, will provide all training and resources to the Manufacturing staff. This role serves as the Mfg. Technical Subject Matter Expect (SME) for Mfg. Operations.

Organizational Context:

Report directly to Director of Manufacturing Science and Technology (MS&T) or delegate.