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Director / Senior Director, Clinical Supply Chain

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. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.Position SummaryThe Clinical Drug Supply Chain team is seeking a Director/Senior Director, Clinical Supply Chain. You will lead outsourced manufacturing activities (drug product, packaging, labeling and commercial drug sourcing) across the supply chain network. You will be responsible for implementation and management of the relevant processes, procedures, metrics, governance, and business reviews. We are open to role being in Mountain View, CA or Remote - USA. \nResponsibilities:Implement and lead Business Operations in Clinical Supply Chain. Support other Chemistry, Manufacturing and Control (CMC) functions as needed.Lead planning, scheduling, manufacture, release timing and shipment of clinical and commercial products.Engage and build relationships with external manufacturing senior leadership to ensure successful manufacture and issue resolution across the external manufacturing network. Plan, coordinate and facilitate all senior leadership site business reviews and visits. Measure and report on over overall performance of external manufacturing partners. Collaborate with internal stakeholders to drive performance (COGS, cycle time, quality) to ensure uninterrupted supply of clinical and commercial products. Work directly with IGM team including and not limited to Clinical Supply Chain Managers, CMC, Clinical Operations and Commercial Planning to ensure long term manufacturing needs are met including input on existing site performance and capabilities and new vendor selection.Support global regulatory filings and quality audits/inspections.This role could assume responsibilities for program level clinical supply management. These include to create and maintain forecasts, collaborate with clinical operations, manufacturing, quality assurance and regulatory to ensure forecasts, study assumption, regulatory filings, etc. are accurate and compliant.QualificationsLevel commensurate with experience.Bachelor’s degree or equivalent in STEM or other relevant field.Ideal candidate will have 12+ years of experience in manufacturing, contract manufacturing, and/or contract manufacturing management.Experience with sterile injectables, small molecule drug substance, oral solid dosages, packaging, and labeling for both clinical and commercial products.Direct supervisory experience not required but preferred.Excellent written and oral communication and presentation skills.Must be highly motivated to rapidly contribute to a fast-paced, start-up environment.Ability to travel approximately 30%.The typical annual salary range for this full-time position is $160,000 - $256,000, plus eligibility for cash and equity incentives. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.Actual individual pay is determined by demonstrated experience and internal equity alignment.\nWe offer a fast-paced, collaborative, team-based and family-like work environment. One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options: · Medical, dental and vision insurance.· The full premium amount for our employees and their dependents is covered by IGM· FSA (Flexible Spending Account)· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance· 401(k) Plan· 120 hours of Paid Time Off, 5 sick days per year, 11 holidays· Cell phone & internet subsidy· Employee Referral Bonus Program· Annual training budget for professional development· Commuter Benefit· Annual bonus program· New hire stock options IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

Job Type
Full Time
Salary
N/A
Experience
N/A
Posted
9 days ago

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