Senior Manager, CMC Project Management

Allogene Therapeutics•South San Francisco, CA

1d•Hybrid

About The Position

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. We are looking for a talented, motivated Senior Manager to join our Portfolio & Program Management Team. This individual will serve as a key project management leader responsible for driving cross-functional planning and execution across one or more pipeline programs. The Senior Manager will partner closely with functional leaders across Operations Technology, Clinical, Regulatory, and other development functions to ensure disciplined planning, risk management, and delivery of program milestones. This role requires a strong foundation in project management with an emphasis on CMC knowledge and the ability to support Clinical Development activities as needed. The ideal candidate is a proactive, solutions-oriented leader who thrives in a fast-paced, highly collaborative environment and can translate program strategy into executable plans. This is a hybrid role based at our headquarters in South San Francisco, CA (US-based, west coast remote may be considered for candidates outside of the area).

Requirements

Bachelor’s Degree in life sciences or related field required (or relevant experience) with at least 7 years of project management experience in similar role in the biotechnology industry (with meaningful exposure to CMC or Operations Technology functions)
At least 3 years of direct project management experience leading cross-functional teams in a matrixed environment; formal project management certification (e.g., PMP) is a plus
Working knowledge of CMC development concepts such as process development, analytical development, manufacturing, quality systems, supply chain, and regulatory CMC requirements
Familiarity with Clinical Development processes and the drug development lifecycle from Pre-IND through BLA is preferred
Cell therapy experience is strongly preferred; experience with biologics or complex modalities is highly desirable
Demonstrated ability to manage complex, cross-functional programs, identify and mitigate risks, and drive execution in a fast-paced, dynamic environment
Proficiency with project management and collaboration tools (e.g., Smartsheet, Microsoft Project, SharePoint, Microsoft Office Suite)
Knowledge of GMP/GxP-regulated environments and quality management systems preferred
Experience supporting late-stage development or commercial-stage programs preferred
Prior experience in a start-up or growth-stage biotechnology organization preferred
Familiarity with cell therapy manufacturing processes and supply chain considerations preferred
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Ability to work independently and as part of a team
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Candidates must be authorized to work in the U.S.

Nice To Haves

Formal project management certification (e.g., PMP) is a plus
Familiarity with Clinical Development processes and the drug development lifecycle from Pre-IND through BLA is preferred
Cell therapy experience is strongly preferred; experience with biologics or complex modalities is highly desirable
Knowledge of GMP/GxP-regulated environments and quality management systems preferred
Experience supporting late-stage development or commercial-stage programs preferred
Prior experience in a start-up or growth-stage biotechnology organization preferred
Familiarity with cell therapy manufacturing processes and supply chain considerations preferred

Responsibilities

Lead cross-functional project teams or sub-teams to manage the planning and execution of program activities in alignment with corporate goals. Teams may include representatives from Process & Product Development, Manufacturing, Quality, Analytical Development, Supply Chain, Clinical Development, Clinical Operations, and Regulatory Affairs.
Develop, maintain, and actively manage integrated project plans including timelines, dependencies, critical path activities, decision points, and budget considerations.
Establish and maintain risk registries; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays.
Facilitate decision-making processes by working with cross-functional teams to develop proposals, analyses, and recommendations for senior management review as part of the governance process.
Serve as the primary project management point of contact for CMC and, as needed, Clinical Development activities on assigned programs.
Ensure comprehensive knowledge of scope, deliverables, timelines, status, and key risks while coordinating cross-functional dependencies across CMC and Clinical workstreams to maintain alignment with program strategy.
Contribute to planning, organization, and preparation of regulatory filings (e.g., IND, BLA, CMC supplements) in partnership with Regulatory and relevant functional teams.
Prepare and deliver concise, data-driven program and project status updates, dashboards, and reports to senior leadership and governance forums.
Manage project team meeting operations including agenda planning, scheduling, minutes preparation, and follow-up on action items and decisions.
Ensure project activities and decisions are clearly communicated, documented, and archived in accordance with team standards and tools.
Foster strong relationships with team members, functional line managers, and external partners to facilitate timely resolution of issues, risks, and opportunities.
Support program-level budget management activities, including tracking expenditures and financial forecasting for assigned programs.
Participate as a member of the Portfolio & Program Management Team to continually improve project management processes, tools, and governance frameworks.
Other duties as assigned.