Job Description

Job Description

Job Description

The Associate will be responsible for assisting with the Raw Materials Workstream of GMP readiness and launch project. A successful candidate will have experience in a GMP environment and be able to handle a wide-range of activities such as conducting a Vendor lead time review, creating Material Specification document and Standard Operating Procedure (SOP) creation. This role will work closely with our internal stakeholders and Project Manager to ensure that the execution of these preparedness activities are completed by their deadlines. This position will report directly to the Senior Manager of Supply Chain Operations.

• Creating and Revising Material Specification Documents for each Bill of Material Item.
• Confirming Manufacturer Details such as Address and Contact details.
• Reviewing and communicating Vendor Change Notifications and maintaining a database.
• Reviewing Item Lead Time details and updating system records.
• Assist with documentation regarding GMP workflows such as receipt and material issuance.
• Assist with Standard Operating Procedure creation and revisions.
• Effectively prioritize and troubleshoot risks to project timelines.
• Ensuring our Material List is updated with the correct product grade.
• Establishing strong relationships with internal business stakeholders.
• Any additional project tasks as assigned by the Sr. Supply Chain Manager.

Requirements

• Bachelor’s degree in business administration, Supply Chain, Logistics or a related field.
• 1-5 years’ experience in material planning, inventory management, purchasing, Supply Chain or Operations experience in Gene Therapy, Bio-Tech, or pharmaceutical environment(s) required.
• Experience operating within a cGMP environment preferred
• Some knowledge of Supply Chain and Manufacturing fundamentals required.
• Strong organizational and time management skills.
• Good communication skills, both verbal and written.
• Proficiency in Microsoft Office and material management systems.
• Strong analytical and problem-solving skills.

Preferred Qualifications

• Experience in cGMP warehousing
• SOP writing experience
• Project Management experience
• Certified to operate a Forklift (selected candidate may be required to gain certification).
• Inventory Management System (Coupa, Ariba, ERP, etc.) and Project Management tools experience.
• Strong experience assessing risk and concisely explaining complex issues to principal business owners.
• Process improvement or project management expertise (PMP, Lean, etc.).
• Extremely customer-focused, taking the time to understand the needs of the business.
• Experience working in a startup environment to address immediate tactical purchasing needs while building for future-scale.
• Strong analytical skills including the ability to quickly synthesize, distill and draw conclusions on large amounts of disparate data.

The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

Company Description

The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

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