Senior Manager, Technical Operations and Strategic Programs
Position Overview
Cartesian Therapeutics is reimagining Cell Therapies with promising breakthroughs to help patients with autoimmune diseases. We are seeking an innovative and experienced Program Manager to lead strategic initiatives in the Technical Operations organization. The scope of the role will include cross-functional management of continuous improvement efforts across process development, MSAT, manufacturing, and QC. The ideal candidate will have technical experience in late-stage CMC for cell therapy or biological drugs and accompanying technical project management expertise.
Key Responsibilities
- Manage execution of the late-stage process development, characterization, and validation efforts within timelines and on budget
- Collaborate with subject matter experts across technical disciplines (MSAT, analytical development, manufacturing, QC, etc.) to develop and implement process validation, qualification, and monitoring plans
- Convene and manage a team that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learned.
- Ensure compliance with all relevant regulations and support regulatory submissions, including the creation of source documents and dossier modules.
- Provide project leadership for developing new and improved processes, and shepherd those improvements through change control.
- Lead creation and review of regulatory CMC packages for IND/BLA/MAA filings.
- Support responses to process development inquiries from health authorities during global product filings and approvals.
- Oversee and ensure the delivery of process development, qualification, and transfer from Process Development to Operations for GMP manufacturing of clinical and commercial cell therapy products.
Skills And Competencies
- Knowledge in GxP compliance and data integrity.
- Proven track record in managing and leading a high-complexity CMC projects with preferred expertise in cell therapy, biologics, process development, transfer, validation, and automation.
- Excellent oral and written communication skills, including faculty with project management tools.
Education And Experience
- Master's/Ph.D. in Biology/Bioengineering/Biotechnology, or a related field.
- 5+ years of experience in biotechnology project management and/or in roles of increasing seniority/leadership with a focus on cell therapy or biologics.
- Experience working in a small/mid-sized biotechnology company preferred.
Salary Notice
At Cartesian Therapeutics, Inc., we are committed to transparency and equity in our compensation practices. The salary range for this position is $150,379 to $181,708 per year. Please note that the final salary will be determined based on several factors, including, but not limited to, years of experience, industry experience, education, and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.
Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.