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Manager / Sr. Manager GMP Supply Chain

Company: IGM Biosciences, Inc.
Location: Mountain View
Posted on: May 12, 2022

Job Description:

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.

We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, and we have initiated a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin's lymphoma (NHL) patients in 2019. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies, for which we have recently initiated a Phase 1 clinical trial. Also, in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.

We are looking for an experienced and motivated Manager / Sr. Manager, Supply Chain to join our team. You will be responsible for planning, implementing, and monitoring our overall supply chain strategy in order to maximize efficiency and productivity. This role will also include a close working relationship with the manufacturing, accounting, and procurement team to perform work related to utilizing an ERP system to meet GMP-level manufacturing. These efforts are all focused to help advance novel cancer therapies into human clinical studies.

Responsibilities:
Design, develop and implement warehouse distribution and logistics solutions to support a biologics-based manufacturing operation
Develop and maintain good vendor relationships from management to licensing, logistics and contract negotiation with key suppliers, and determine supply chain KPIs for vendors
Operate ERP system to support manufacturing under GMP for Phase I Clinical Trials
Collaborate closely with Upstream and Downstream Development, Manufacturing, Quality, Accounting, and Procurement groups to meet project timelines and maintain appropriate inventory
Maintain existing and write new, clear, and concise Standard Operating Procedures(SOPs), production documents and forms, and/or master plan to facilitate GMP manufacturing
Plan, implement, and manage the end-to-end supply chain and waste management
Manage, train, develop and evaluate team members
Hold self and direct reports accountable for continuous improvement and goal execution
Identify process bottlenecks, drive process improvement and measure progress in all areas of responsibility, including but not limited to promoting a safety-first culture, delivering on quality and on-time performance, with a focus on maintaining cost-effectiveness, and efficiency
Support the Request For Proposal (RFP) and due diligence process for all external manufacturing contracts
Work with Finance, Procurement, and Manufacturing teams to determine the best vendors and distributors for our business
Qualifications:
3+ years of previous working experience as a Supply Chain Manager in a GMP facility
3+ years of demonstrated effective leadership skills, team management, and exemplary communication skills
Knowledge of GMP manufacturing requirements related to clinical production and commercial manufacturing of injectable biologic products
Hands-on experience with supply chain management ERP software (such as SAP MM, AP Modules, SAP Plant Maintenance)
Safety-first orientation with a strong sense of urgency, ownership, and pride in the entire team's performance and its impact on the company's success
Strong critical thinking and problem-solving skills and ability to escalate matters appropriately and influence senior leadership as required
Strong ability to lead and mentor by example
Lean Manufacturing implementation experience preferred
Excellent verbal and written communication skills, adept at collaborating across multiple groups
Proficiency using Microsoft Office, relational databases, cloud-based document control systems (i.e. D365, TrackWise, Veeva, Master Control, etc.), and graphing programs
Aseptic technique a plus
Able to effectively manage competing priorities, provide and receive constructive feedback
Extremely well organized with great attention to detail
Able to thrive in a fast-paced, start-up environment
Must be able to commute to Mountain View, CA with up to 10% Business Travel required
Capable of lifting upwards of 50 pounds

Keywords: IGM Biosciences, Inc., Mountain View , Manager / Sr. Manager GMP Supply Chain, Executive , Mountain View, California

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