Technical BioPharma Manufacturing MSAT Engineer MA-TC

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 MSAT Engineer MA-TC opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Senior Process Engineer will be responsible for MSAT activities and deliverables and for providing technical leadership and support to expanding manufacturing process platforms and pipeline in cell / gene therapies. The position will support operations including upstream and downstream drug substance manufacturing and drug product filling. The role is also responsible for effective collaboration with several stakeholders including but not limited to: Manufacturing, Process Development, Quality Assurance, R&D, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various vendors.

Essential Job Responsibilities:

• Deliver a tech transfer and product lifecycle management program that incorporates phase appropriate requirements and expectations, improves tech transfer efficiency, and drives process optimization and cost of goods reduction.


• Lead tech transfer discussions between sending unit (Research, Process Development, and Pilot Plant) and receiving unit (Manufacturing, QA, QC, Supply Chain, Automation, Process Engineering, and Validation)


• Author process descriptions, engineering protocols, and technical reports. Create feasibility/gap assessments and facility fit analysis for new products and processes.


• Drive risk assessments for new processes, process changes, and process comparability


• Author process comparability protocols for drug substance and drug product


• Own new product introduction and product phase progression change controls.


• Manage manufacturing process sample plans (site dependent-Sanford).


• Support audits and inspections from internal and health authority organizations. Support regulatory interactions and submissions.


• Collect, organize, analyze, and present process data to enhance process understanding and identify improvements. Author engineering and campaign summary reports. Support process deviation investigations, root cause analysis, and CAPAs


• Represent MSAT and the site in various CMC meetings with Regulatory and Program Leads