Senior Manager - Molecular Manufacturing Operations

Caris Life Sciences•Phoenix, AZ

About The Position

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Senior Manager of Molecular Manufacturing Operations is responsible for the technical components of the Molecular Lab within clinical business and manufacturing oversight.

Requirements

Bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
6+ years of laboratory experience in high-complexity patient testing, 1 of which is in molecular pathology methods.
3+ years leadership experience.

Nice To Haves

Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution preferred.
6+ years of experience in molecular methods in a GMP, CUA, NYS, CAP, ISO regulated environment.
3+ years leadership experience within clinical laboratory environment preferred.
Demonstrate clear ability to explain previous molecular assay experience, including the function of positive/negative controls, sample results, and data interpretation.
Possess relevant molecular skill set consisting of molecular fundamentals such as: RNA and DNA extraction, PCR, reverse transcription, and gel electrophoresis.
Experience with real-time PCR, microarray, fragment analysis, Sanger sequencing, and Next Generation Sequencing preferred.
CLSp(MB), MB(ASCP) certification.

Responsibilities

Ensures that all team members are provided with complete process and theory training for manufacturing processes.
Directs inventory planning and drives manufacturing schedules to meet clinical and supply chain needs.
Develops and updates SOPs as needed and monitors operational function on a regular basis to ensure that protocol drift is not occurring.
Monitors department metrics and performance of procedures, quality control, and production efficiency and provides data to senior leadership on a regular basis.
Works closely with cross functional team members during new product transfer to ensure that all quality and operational details are discussed and implemented during validation.
Work closely with the quality and regulatory teams in maintaining manufacturing procedures and/or troubleshooting.
Manages inventory and scheduling according to business needs.
Organizes and executes studies associated with manufactured components.
Assist in creation of requirements for LIMS improvement and subsequent user acceptance testing.
Support compliance to all applicable regulatory and standard requirements (GMP, FDA, CLIA, NYS, CAP, ISO, etc.).
Consult with the Laboratory (Medical) Director and other professional on staff, as needed.
Make recommendations regarding hiring, discipline and promotion of subordinates; authorizes leave and overtime; evaluates and rates employee performance.
Maintain confidentiality of all patient information in accordance with federal, state and local guidelines and regulations.
Represent the manufacturing organization at Management Review meetings.
Develop, train and mentor staff.
Supports the general supervisor in achieving compliance with CLIA, CAP, NYS DOH and ISO 15189.
This position has been delegated the responsibility of assessing employee competencies.
Accepts other duties as assigned.