Senior Manager, Technical Operations and Strategic ...

OverviewSenior Manager, Technical Operations and Strategic Programs is a role at Cartesian Therapeutics focused on leading strategic initiatives within the Technical Operations organization. The scope includes cross-functional management of continuous improvement efforts across process development, MSAT, manufacturing, and QC, with emphasis on late-stage CMC for cell therapy or biological drugs and technical project management. ResponsibilitiesManage execution of late-stage process development, characterization, and validation efforts within timelines and on budgetCollaborate with subject matter experts across technical disciplines (MSAT, analytical development, manufacturing, QC, etc.) to develop and implement process validation, qualification, and monitoring plansConvene and manage a team that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learnedEnsure compliance with all relevant regulations and support regulatory submissions, including creation of source documents and dossier modulesProvide project leadership for developing new and improved processes, and shepherd improvements through change controlLead creation and review of regulatory CMC packages for IND/BLA/MAA filingsSupport responses to process development inquiries from health authorities during global product filings and approvalsOversee and ensure the delivery of process development, qualification, and transfer from Process Development to Operations for GMP manufacturing of clinical and commercial cell therapy productsQualificationsKnowledge in GxP compliance and data integrityProven track record in managing and leading high-complexity CMC projects with preferred expertise in cell therapy, biologics, process development, transfer, validation, and automationExcellent oral and written communication skills, including project management toolsEducation and ExperienceMaster's/Ph.D. in Biology/Bioengineering/Biotechnology or related field5+ years of experience in biotechnology project management and/or roles of increasing seniority/leadership with a focus on cell therapy or biologicsExperience in a small/mid-sized biotechnology company preferredSalary NoticeSalary range: $150,379 to $181,708 per year. Final salary determined based on factors including experience, education, and skills. Cartesian is an Equal Opportunity Employer and commits to fair treatment without regard to protected characteristics.Additional informationSeniority level: DirectorEmployment type: Full-timeJob function: Management and ManufacturingLocationLeesburg, VA #J-18808-Ljbffr

Created: 2025-10-06