Director / Sr. Director, Clinical Supply Planning and Project Management

Company: IGM Biosciences, Inc.
Location: Mountain View
Posted on: September 4, 2024

Job Description:

AboutIGM Biosciences, Inc.IGM Biosciences (Nasdaq:IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. The Company's pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers and receptor cross-linking agonists. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visit.IgM Antibodies and Autoimmune and Inflammatory DiseasesAntibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases. We are committed to exploring how our IgM antibody platform's unique structure and binding propertiescan improve outcomes for patients with these serious conditions.IgM Antibodies and OncologyThe potential of our IgM antibodies drives our focus on oncology. Leveraging the power of avidity and the strong and durable binding of our IgM antibodies, we are developing new treatment options for cancer patients. Our initial efforts in this field are centered around the broad application of IgM antibodies to activate receptors, triggering the programmed death of cancer cells.Position SummaryAs Director, Clinical Supply Planning and Project Management, you will lead all clinical and commercial supply planning activities across the supply chain. Initially, you will be responsible for the Clinical & Operations Planning (C&OP) processes, including creating and maintaining a detailed plan for all internal and external drug substance, drug product, packaging, and labeling operations. You will also develop and drive the Long-Range Operating Plan (LROP) and the Sales and Operations Planning (S&OP) processes.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.Qualifications:
  • Level commensurate with experience.
  • 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.$195,000 - $240,000 a yearThis range reflects the job's characteristics, 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 the applicant's geographic location.Actual individual pay is determined by demonstrated experience and internal equity alignment.We offer a fast-paced, collaborative, team-based, work environment.One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options: -Medical, dental and vision insurance.oThe full premium amount for our employees and their dependents is covered by IGMoFSA (Flexible Spending Account) or HSA (Health Savings Account) -STD, LTD, Basic Life and AD&D Insurance,Supplemental Life and AD&D InsuranceoVoluntary Life Insurance and Disability -401(k) Plan with Employer Match -3 Weeks of Paid Time Off, 5 sick days per year, 12 holidays -Cell phone & internet subsidy -Employee Referral Bonus Program -Annual training budget for professional development -Commuter Benefit -Annual bonus program -New hire stockoAnnual refresh grants -ESPP (Employee Stock Purchase Plan)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.
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Keywords: IGM Biosciences, Inc., Mountain View , Director / Sr. Director, Clinical Supply Planning and Project Management, Healthcare , Mountain View, California