147 applicants

Company

Original Job Post

IGM Biosciences, Inc. · 2 days ago

Director, Supply Planning and Project Management

San Francisco Bay Area

Full-time

Onsite

Director

15+ years exp

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Hiring Manager

Janaye Ruhl

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Responsibilities

Must have Biopharmaceutical industry and clinical drug substance experience

Lead and develop direct reports and collaborate with cross-functional teams to plan and deliver on-time, compliant clinical supply per the clinical development plan.

Develop and lead a C&OP process that integrates clinical supply and demand while working directly with clinical operations and clinical supply chain organizations.

Work with the manufacturing team and CMOs to ensure the execution of required manufacturing batches.

Oversee the planning and procurement of drug substances and drug products from CDMOs.

Develop sustainable inventory control practices across the supply chain network and track/report supply chain performance to plan for raw materials, starting materials, work-in-process, and finished goods.

Drive a long-range (3-5 years) planning process that is aligned with corporate, financial, pipeline, and commercial launch plans.

Develop and execute an effective supplier management program.

Maintain and update Interactive Response Technology (IRT) system data as necessary.

Develop and implement knowledge management tools and processes.

Forecast and plan for program management support across all development programs.

Lead and support major/complex initiatives and decisions such as CDMO selection, technology evaluation, and make vs. buy.

Manage capital projects and transformational projects.

Facilitate and plan workshops and initiatives.

Facilitate budget, forecast, and incremental requests.

Support Pivotal Readiness and Late-Stage Project Management across CMC

Facilitate and manage Tech Transfers to CDMO

Implement and conduct process monitoring across the manufacturing value stream.

Serve as a SPOC for person-in-plant needs and coordination.

Documentation development and change management.

Drive improvements across the entire manufacturing value stream by utilizing CPI and lean manufacturing techniques such as 5S, RCA, Gemba walks, five waste elimination, CEDAC, TPM, etc.

Measure performance across the internal and external manufacturing network, understand related risks to operations and supply, and work with partners to implement appropriate mitigation strategies.

Work across the manufacturing network, process development, procurement/strategic sourcing, quality, and finance to understand quality, cost, and standard timeline performance targets, including supply performance, capacity constraints, supplier risks, COGS, and clinical deliverables.

Develop, implement, and improve business processes across CMC operations.

Plan and facilitate operational reviews.

Develop and implement an OE training and education program.

Qualification

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Supply Chain ManagementERP SystemsCGMPPharmaceutical Industry KnowledgeTechnical WritingCommunicationCollaborationMotivation

Required

Bachelor’s degree or equivalent is required.

Ideal candidate will have 15+ years of relevant supply chain experience.

Experience with ERP systems for planning.

Experience working in cGMP manufacturing environments.

Solid understanding of pharmaceutical development, manufacturing, packaging, and labeling.

Eager to communicate and collaborate with team members across functions including but not limited to clinical operations, manufacturing, commercial, finance, procurement, and IT.

Experience writing and presenting clearly on supply topics.

Must be highly motivated to contribute to a fast-paced, start-up environment rapidly.

Company

IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases.

Founded in 2010

Mountain View, California, USA

201-500 employees

https://igmbio.com

H1B Sponsorship

IGM Biosciences, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (4)

2022 (3)

2021 (7)

2020 (5)