CMC Lead Project Manager

InduPro TherapeuticsSeattle, WA
$96 - $106Onsite

About The Position

About InduPro InduPro develops life-changing therapies using a proprietary cell-surface labeling platform that leverages spatial proximity within microenvironments to enable the discovery of novel multispecific biologics. This approach has generated a growing pipeline of candidates advancing into clinical development across oncology and autoimmune diseases. InduPro fosters a culture of innovation at every level. The Opportunity We are seeking an enthusiastic and highly-motivated Contract CMC Lead Project Manager to help advance our emerging pipeline from development candidate selection through IND-enabling studies and beyond. The candidate will drive execution across CMC and serve as a force multiplier to the Executive Director, CMC, with ability to independently represent CMC in team discussions when needed, they should demonstrate an ability to think outside-the-box and work collaboratively in an adaptive and rapidly moving work environment.

Requirements

  • Self-directed quick learner who is proactive and takes initiative, with the ability to adapt to a dynamic environment and a demonstrated ability to grasp general knowledge of multiple fields
  • Strong competencies in planning, project management, and organization with the ability to lead multiple activities in parallel while maintaining a focus on quality
  • Exceptional interpersonal skills to effectively work in a team or matrix environment, to collaborate and coordinate with internal and external department staff at various levels, and to influence others effectively; able to build and collaborate with a cross-functional network
  • Creative and critical problem-solving skills with high comfort in ambiguous situations
  • Strong oral and written communication skills
  • Familiarity with SmartSheet or other project management software
  • Ability to integrate knowledge from multiple sources and to work both independently and cross-functionally
  • 2+ years of demonstrated project management experience supporting research programs in the biopharmaceutical or biotech industry
  • 2+ years of managerial experience directly handling people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
  • Proven track record of successfully supporting CMC programs from development through commercialization, including vendor oversight, integrated plans, and governance reporting
  • Physical presence at the InduPro worksite, or in the field, is required for this role.

Responsibilities

  • Support and execute the strategic vision for CMC programs, aligning with organizational goals and product requirements, translating strategy into integrated execution plans, key milestones, and decision points.
  • Own integrated CMC timelines, governance reporting, and risk/issue management; escalate scope, resourcing, strategic tradeoffs, and budget exceptions to leadership for decision
  • Lead cross-functional execution of the CMC plan to ensure successful delivery of CMC initiatives; facilitate alignment, clarify accountability, and escalate tradeoffs/risks to leadership as needed
  • Coordinate activities within CMC to ensure efficient and cost-effective production of candidate molecules; drive readiness for key deliverables (plans, protocols, batch documentation readiness, method readiness) as appropriate to phase
  • Leverage strong project and facilitation skills to optimize team meetings and decision making, including agendas, action/owner tracking, decision logs, and follow-through
  • Serve as a liaison between internal stakeholders and external partners, such as contract manufacturing organizations (CDMOs) and vendors, ensuring clear communication and alignment on scope, timelines, deliverables, and change control/escalations.
  • Own budget tracking and forecasting within CMC for assigned programs; prepare budget updates and variance analyses, identifying variances early, and coordinating mitigation plans with functional leads.
  • Manage project timelines and monitor team adherence to project plans
  • Identify project challenges or resource gaps and facilitate resolution
  • Facilitate effective project meetings and ensure key stakeholders are apprised of changes
  • Agenda setting and scheduling
  • Monitor and communicate progress and adherence to timelines
  • Manage web-based file organization; meeting minutes, documents, publications, etc.
  • Identify resource gaps and work with Project Teams to resolve, taking appropriate action when necessary
  • Work with external partners and collaborators to ensure adherence to timelines, budgets and deliverables
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