Massachusetts Green Jobs

Supply Chain Analyst I

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 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 problem-solving, decision-making skills and time management skills

• Strong organizational, prioritization skills, able to multitask / work independently with minimal direction or work in a team environment, develops, and maintains effective relationships with colleagues across the organization

• Will support and demonstrate quality standards to ensure data of highest quality

• Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects, as assigned

Preferred:

• 3+ years working in a pharmaceutical or Bio-Pharma environment as a Supply Chain or Business Analyst or similar role.

• General understanding of biopharmaceutical development, clinical research, biologics manufacturing, cell therapy manufacturing.

• Engineering experience/degree a plus.

• Advanced skills with Oracle ERP system.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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-TD

Category Massachusetts TC

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

EOE including Disability/Protected Veterans