Cell Production Manager

Cytotheryx is seeking a strategic, hands-on Cell Production Manager to lead early-stage R&D-grade manufacturing and support the operational transition to preclinical- and IND-enabling production of therapeutic-grade hepatocyte products. This individual will serve as a key coordinator across leadership, production staff, and the QA/QC/regulatory team to ensure Cytotheryx’s manufacturing platform meets both scientific performance and compliance standards.  

The ideal candidate will have demonstrated experience in primary cell processing, laboratory operations, and quality systems, with the ability to operate independently in a dynamic, early-stage environment. This is a high-impact opportunity for an operationally minded leader to shape a novel cell manufacturing platform that underpins our various therapeutic programs. 

A strong foundation in laboratory techniques, GMP regulations, and quality systems is expected. Excellent organizational and communication skills are essential. This role will grow to encompass oversight of cell production operations as they expand to support clinical development. 

Duties and Responsibilities

• Lead and participate in the production of cell products regulated by the FDA.
• Collaborate with Operations and QA to establish cGMP-aligned procedures, training systems, and quality documentation for preclinical and clinical-scale hepatocyte production.
• Translate R&D workflows into GMP-aligned, documented manufacturing processes in collaboration with QA/QC and Regulatory.
• Work with Facilities Management to oversee the installation and maintenance of laboratory/production equipment that meets technical and regulatory requirements.
• Support method optimization for cell quality, yield, and sterility in alignment with downstream therapeutic and device applications.
• Lead or support cryopreservation, thaw, and cell recovery workflows; contribute to the design of scalable cell banking strategies for both internal and partnered programs.
• Participate in developing/maintaining electronic QMS and batch record system(s).
• Responsible for presenting program budget estimations to leadership.
• Manage laboratory scheduling, inventory systems, reagent prep, and resource forecasting.
• Ensure compliance with laboratory safety standards and routine equipment maintenance.
• Seek ways to continually improve processes.

Supervisory Responsibilities

• Mentor and train cell production staff, providing day-to-day guidance and performance feedback.

Education and Experience

• BA/BS in cell biology, biotechnology, or biomedical engineering with 10+ years of experience or MS/PhD with 5+ years of experience in cell manufacturing, bioproduction, or translational R&D in a regulated environment.
  Experience supporting the translation of cell-based therapies from discovery to IND or clinical phase is highly desirable.
• Proficiency in cell biology workflows with culturing and assaying primary cells (especially hepatocytes, organoids, or more advanced hepatic cell model systems) is a plus.
• Previous history of managerial experience
• Proven success in coordinating between laboratory execution and QA/QC or regulatory functions.
• Experience with SOP development, deviation tracking, batch record documentation, and QMS tools.
• Strong organizational and communication skills; able to interface across technical and compliance teams.
• Proficient in Word, Excel, Outlook, and PowerPoint. Experience working with data visualization and statistical software (GraphPad Prism, JMP, R, etc.)

Desired Key Competencies

• Ability to thrive in team-based settings.
• Experience supporting laboratory design, cleanroom layout, equipment commissioning, or buildout of regulated production spaces strongly preferred.
• Ability to achieve goals in a milestone-driven, rapidly changing research environment.
• Excellent organizational and documentation skills.
• Ability to flourish with minimal guidance, be proactive, and handle uncertainty.
• Ability to manage and schedule multiple tasks with various personnel in an efficient manner.
• Possess a high degree of personal responsibility.
• Demonstrate the highest ethical standards and trustworthiness.
• Good verbal and written communication skills and interpersonal skills.
• Ability to maintain a high degree of accuracy and strict attention to detail.