Supply Chain Specialist

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 .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Role

The Supply Chain Specialist will be a key contributor to ensure cGMP compliance for Supply Chain related activities. This role will be responsible for the creation and maintenance of material specification with the EDMS and manage the item master maintenance within the ERP System.

Responsibilities

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

• Manages material item master maintenance in the ERP system.

• Manages and/or assesses Supply Chain deviations, investigations, CAPSs, Vendor Change Notifications (VCN), Supplier Change Action Request (SCAR), related to GMP materials.

• Acts as liaison between Astellas and Supplier for resolving GMP material quality issues

• 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 and makes informed timely decisions largely in an independent fashion; assumes responsibility and communicates to appropriate stakeholders.

• User for item master Maintenance within ERP system

• Other duties and projects as assigned.

Quantitative Dimensions

The Supply Chain Specialist is responsible for ensuring all operations meet, or exceed, cGMP regulations.

Organizational Context

The Supply Chain Specialist will typically report to the Senior Manager, Supply Chain and Materials or head of 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.

Required Qualifications

• Bachelor’s degree with 2 plus years of work experience or 3 plus years direct working experience in bio/pharma industry in Supply Chain, or Associate degree with 3 plus years work experience or 5 plus years direct working experience in bio/pharma industry in Supply Chain

• Experience in regulatory compliance with respect to investigations and process change control. Strong knowledge of cGMPs/FDA and EU regulations.

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

• Strong technical skills interpreting material specifications in a GMP environment, strong experience leading technically complex projects, and strong computer skills including MS Office (Word, Excel). Experience with ERP systems, MRP and Inventory Control Systems.

• Excellent communication skills both verbal and written and strong problem-solving, decision-making skills and time management skills.

• Exceptional organizational, prioritization skills, along with the ability to multitask and work independently with minimal direction or work in a team environment required.

• Develops and maintains effective relationships with colleagues across the organization.

• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Preferred Qualifications

• Experience/familiarity in a facility startup environment.

• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines.

• Ability to deal with ambiguity, creative and pragmatic approach to problem solving.

• Exposure to regulatory authority inspections and inspection readiness.

Working Conditions

• 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.

• Intermediate to Advanced skills with Oracle ERP system.

• Previous experience creatin/updating material specifications (e.g. chemicals, reagents, solvents, disposable single-use materials, components, etc.)

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

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Category Sanford TC

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

EOE including Disability/Protected Veterans