Senior Project Manager - Associate Director, CMC

Job Description

Job Description

What We Do:

Calidi Biotherapeutics is a clinical-stage immuno-oncology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations.

Job Overview/Summary:

The Project Manager, is a critical cross-functional role responsible for driving the execution of Calidi's outsourced manufacturing and testing programs for CLD-401. This individual serves as Calidi's primary operational interface with the contracted CDMO and coordinates all contract testing laboratory activities across the CLD-401 IND-enabling campaign. The role owns the program schedule, deliverable tracking, change order management, and milestone invoice management for a multi-phase CGMP manufacturing campaign encompassing cell banking, virus banking, upstream/downstream process development, analytical method transfer, aseptic process simulation, GMP engineering runs, CGMP drug product production.

This position collaborates daily with Calidi's Quality Control, Manufacturing Operations, Quality Assurance, Regulatory Affairs, Process Development and Analytical Development functions to ensure that all CMC deliverables are on track, technically sound, and aligned with IND-enabling requirements under 21 CFR Parts 210/211, 11, 312, and 600–680, and applicable ICH guidelines.

The Project Manager, will work closely with the Head of Technical Operations and other cross-functional units to support CMC priorities, program alignment, and timely escalation of critical path issues.

Responsibilities:

• Serve as Calidi’s primary point of contact with external CDMO and Contract Testing Lab partners, overseeing all manufacturing, analytical, and program management activities, while fostering strong cross-functional and external relationships.
• Coordinate technology and knowledge transfer activities from Calidi to our external manufacturing partner, including preparation and timely delivery of comprehensive technical packages covering process descriptions, methods, and supporting development data.
• Develop and manage project plans, timelines, and deliverables in Smartsheet or equivalent PM tools, ensuring scope, assumptions, and authorizations are documented.
• Coordinate review and approval of key CMC deliverables from external partners including development reports, certificates of analysis, executed batch records, and disposition packages.
• Provide clear and timely communication to stakeholders, including status reports and dashboards.
• Monitor and communicate program risks, schedule variances, and technical issues to Calidi leadership; escalate critical path threats proactively.
• Bridge communication between technical functions and leadership to drive alignment, support timely decision-making, and resolve program issues before they impact schedule or deliverables.
• Identify and negotiate change orders for scope modifications, schedule deviations, or additional development activities; track change order status and budget impact.
• Organize and lead internal project meetings, prepare agendas, and distribute meeting minutes.
• Review and approve program management documentation generated by external partners including meeting minutes, action item logs, and program deliverables.
• Lead project initiation, planning, execution, monitoring, and closeout in accordance with project management best practices; drive adoption of efficiency tools and standardized processes to support CMC program delivery.
• Review and track milestone-based invoices against the contracted pricing schedule; liaise with Finance to ensure timely payment processing.
• Participate in and drive cross-functional team meetings; provide program status updates to senior leadership on schedule, risks, and IND readiness milestones.
• Support regulatory interactions as needed, and coordinate deliverables for regulatory filings.
• Support the Quality Control team by tracking and driving completion of routine but critical operational tasks, including sample testing coordination, data package receipt, laboratory deliverables, document reviews, and vendor follow-up.
• Coordinate outsourced analytical testing activities with contract testing laboratories, including sample shipment planning, testing schedule tracking, analytical data package follow-up, and escalation of technical or documentation issues.
• Support batch review workflows by tracking QC and Manufacturing Operations deliverables, test results, certificates of analysis, executed batch record inputs, analytical data packages, and documentation needed for batch disposition.
• Serve or technical owner for selected outsourced analytical assays, as assigned, including coordination of assay transfer, execution oversight, data review support, troubleshooting, and communication with external laboratories.
• Partner with Manufacturing, QC, QA, Process Development and Analytical Development to ensure manufacturing-related deliverables, testing plans, review comments, and open technical questions are tracked to timely closure.
• Other duties as assigned.

Qualifications:

• BS or higher degree in Life Sciences, Chemistry, or a related field (e.g., Chemistry, Biology, Immunology, Microbiology) and formal training in CGMP, GCP, GLP, regulatory requirements
• PMP certification is preferred with minimum of 5 years of experience
• Must be highly organized, detail oriented, with the ability to multi-task and be flexible and adaptive in a fast-paced environment.
• Excellent oral and written communication
• Familiarity with Smartsheet, MS Project or other timeline / resource management tool
• Experience in a GxP environment
• Ability to travel on occasion including vendor site visits, conferences.
• Experience supporting, QC, analytical testing, manufacturing, CDMO, or contract testing laboratory activities in a regulated environment.
• Experience reviewing or coordinating review of technical and GxP documentation, such as batch records, certificates of analysis, analytical data packages, development reports, deviations, change controls, protocols, or technical reports.
• Experience with outsourced analytical assays or technical oversight of external laboratory testing is preferred, including potency, infectivity, qPCR/ddPCR, identity, purity, sterility, mycoplasma, endotoxin, residual host cell DNA/protein, or cell-based assays.

Mathematical Skills:

• Ability to work with mathematical concepts such as calculation of dilutions and statistical analyses.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Language Skills :

• Ability to read and understand technical procedures.
• Ability to write protocols and reports.
• Ability to effectively present data and respond to questions from co-workers.
• Good verbal and written communication skills.

The Perks:

• Competitive Total Rewards package (Medical, Dental, Vision, 401k with 4% Safe-Harbor match) offered to full-time employees

Work Location:

Calidi Biotherapeutics employment provides the opportunity to work in beautiful San Diego, California only minutes from the nearest beach.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Calidi Biotherapeutics provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may let the recruiting contact know. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives:

Calidi Biotherapeutics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Calidi Biotherapeutics employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Calidi Biotherapeutics. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Employer’s Rights:

This job description does not list all the duties of the job. You may be asked by supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description.

The employer has the right to revise this job description at any time. The job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason.