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Supply Chain Analyst I

3 months ago

Westborough, United States Astellas Full time

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 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 **Supply Chain Analyst I** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**

**Purpose**:
The Supply Chain Analyst I will provide input and oversight to ensure all operations meet, or exceed, cGMP regulations, guaranteeing high level of quality of the Drug Substance and Drug Product Processes. This role will be responsible for the creation and maintenance of Astellas’ materials numbers, including uploading them to the corresponding database. Will be accountable for materials specifications, coordinating the development of supporting data with stakeholder departments, performing the corresponding electronic database (EDMS) updates, and develop and maintain corresponding procedures as the SME on the areas under control.

**Essential Job Responsibilities**:
Creates and updates materials specifications with support from related departments (Manufacturing, PD, QA / QC, etc.), updates the corresponding EDMS and manage their approval

Produces, processes, and maintains record keeping of purchase requests and purchase orders, direct and indirect, in accordance with documented procurement process

Generates, uploads, and performs updates for materials/components into the Astellas ERP system and reviews proposals and negotiates pricing with suppliers

Establishes, reviews, and executes vendor contracts

Owns and/or assesses Supply Chain (Warehouse/Purchasing) deviations, investigations, CAPAs/change controls related to GMP materials quality issues covered by the SCAR (Supplier Corrective Action Request) procedure, with the assistance of Warehouse/Purchasing group

Develops/updates corresponding area procedures (SOPs) to ensure GMP compliance and assures compliance with company policies, applicable GMP procedures and regulatory agencies on matters related to Supply Chain, safety, and environmental

Submits accurate and timely administrative reports, attends meetings, works to resolve any Supply Chain related issues within a timely manner and maintains/files GMP related data in an organized manner for record/audit purposes

Makes informed, timely, and independent decisions; assumes responsibility and communicates to appropriate stakeholders

**Quantitative Dimensions**:
The Supply Chain Analyst is responsible for ensuring all operations meet, or exceed, cGMP regulations.

**Organizational Context**:
The Supply Chain Analyst I will typically report to the Manager, Supply Chain and Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

**Qualifications**:
**Required**:
BS / BA degree with 2 plus years of work experience or 1 plus years direct working experience in the bio/pharma industry in a Supply Chain Analyst role or Associate degree with 4 plus years work experience or 3 plus years direct working experience in the bio/pharma industry as a Supply Chain Analyst or High School diploma with 5+ years of direct industry experience as a Supply Chain Analyst.

Expertise in regulatory compliance with respect to investigations and process change control.

Strong knowledge of cGMPs/FDA and EU regulations

Experience creating/updating materials specifications, including chemicals, reagents, solvents, disposable single-use materials, components, etc.

Solid technical skills interpreting material specifications in a GMP environment

Strong experience leading technically complex projects.

Strong computer skills including MS Office (Word, Excel). Experience with ERP systems, MRP and Inventory Control Systems

Excellent communications skills both verbal and written

Strong