Senior Manager/Associate Director, QC Microbiology - Cartesian Therapeutics

Summary

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. We are seeking a Sr. Manager/Associate Director of QC Microbiology to oversee the execution of the microbiology program supporting lot release and environmental monitoring. The successful applicant will have leadership skills and a track record of success working well in a team environment.

Key Responsibilities:

• Oversight and execution of microbiology programs supporting lot release and environmental monitoring for Cartesian and managing the QC Microbiology team.
• Serve as principal QC liaison with site manufacturing operations and quality operations with respect to microbiological routine testing and support.
• Recruitment, development, and management of the Microbiology labs.
• Management and oversight of the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting.
• Developing and implementing innovative technologies, methods, and processes for microbial analysis.
• Ensuring that all laboratory activities are conducted in compliance with relevant regulations and guidelines.
• Providing scientific leadership and technical expertise to the laboratory team.
• Managing and mentoring a team of microbiologists and technicians, including hiring, training, and performance evaluation.
• Collaborating with other departments and external partners to support applicable projects.
• Oversight of the maintenance and calibration of laboratory equipment and instrumentation.
• Preparing reports and presentations for senior management and external stakeholders.
• Ensuring that the QC Microbiology Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations.
• Supporting the QC planning and scheduling activities as required.

Requirements and Desired Experience:

• A post graduate degree in Microbiology is required.
• 5 years' experience working on Microbiology focused projects, including environmental monitoring, in the Pharmaceutical Industry.
• 3 years of experience leading and developing a team with 3 or more direct reports.
• The candidate will have proven success working well in a team environment, as well as skills to manage a team of professionals through changing business needs.
• Demonstrated ability to influence work cross-functionally in a matrixed environment with a small to mid-sized pre-commercial company.
• Experience with technical transfer of new products and product changeover required.
• Extensive knowledge of US and EMA GMP regulations and guidance.
• Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including microbiological release testing.
• Excellent written and verbal communication skills, with the ability to present complex scientific information to a variety of audiences.
• Proven ability to plan, execute, and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.

Work Environment:

The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.

Salary Notice:

At Cartesian Therapeutics, we are committed to transparency and equity in our compensation practices. The salary range for this position is $130,000 - $175,000 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.