Director / Sr. Director, Clinical Supply Planning and Project Management
Company: IGM Biosciences, Inc.
Location: Mountain View
Posted on: October 2, 2024
Job Description:
About IGM 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
.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.Salary: $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.
- FSA (Flexible Spending Account) or HSA (Health Savings
Account).
- STD, LTD, Basic Life and AD&D Insurance, Supplemental Life
and AD&D Insurance.
- 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 stock with annual 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., Santa Cruz , Director / Sr. Director, Clinical Supply Planning and Project Management, Executive , Mountain View, California
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