Molecular Manufacturing Technologist (1st Shift)

Caris Life Sciences•Phoenix, AZ

12d•Onsite

About The Position

At Caris, we are dedicated to transforming cancer care and improving lives through precision medicine. We leverage cutting-edge molecular science and AI to provide unique answers for each patient. Our mission extends beyond cancer, aiming to push the frontiers of medicine and lead a healthcare revolution driven by innovation, compassion, and purpose. We are seeking passionate individuals to join us in improving the human condition across multiple diseases and making a significant impact.

Requirements

Bachelor's degree in chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
3+ years relevant molecular and/or manufacturing experience with at least 1 year being high complexity testing.
Demonstrates mastery of molecular assay operations and QC systems.
Experience in FDA regulated industries.
Proficient in Microsoft Office programs, such as Word, Excel, and Outlook.
General working knowledge of internet for business use, and skilled in operating office equipment.

Nice To Haves

Master's degree in chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
Experience in ISO 13485 regulated industries.
Operates with high autonomy and professionalism.
Technical authority with strong analytical judgement.
Proactive, solution-oriented and collaborative.
Mastery of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.
Ability to work in a fast-paced, deadline driven environment.
Proficient in verbal and written communication skills.
Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
Commitment to the successful achievement of the team and organizational goals through a desire to participate with and help other members of the team.
Demonstrate a focus on listening to and understanding client/customer needs.

Responsibilities

Follows established laboratory protocols governed by standard operating procedures (SOPs).
Performs molecular techniques with proficiency: cell culture, control and reagent manufacturing, nucleic acid extraction, quantification and normalization, next generation sequencing (NGS) and other laboratory assignments with consistency and precision.
Maintains exceptional quality standards for all molecular and manufacturing processes.
Operates and performs routine troubleshooting on laboratory instruments and accessories used in manufacturing workflows.
Maintains laboratory equipment, accessories and instruments used in processing by performing routine maintenance.
Assists with training and mentorship of new and existing manufacturing technologists.
Prepares Corrective and Preventive Action (CAPA), Quality Event (QE) and/or Deviation (DEV) documents for nonconformance events observed during manufacturing operations.
Collaborates with the Quality, Product Development, Translational Science, and Regulatory teams to validate or implement new technologies, methods and equipment.
Proficiency in the Laboratory Information Management (LIMS) tracking system to accurately perform and record day-to-day tasks.
Represents the department in audits, investigations and cross-functional initiatives.
Identifies and implements opportunities for continuous improvement, innovation and efficiency.
Initiates, tracks, and documents continuing education hours.
Performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual’s education, training, technical abilities and experience.
Follow the laboratory’s procedures for specimen, material, and reagent handling and processing.
Adhere to and document all the laboratory’s quality control policies and activities as governed by FDA, CAP, CLIA, NYS and ISO regulatory standards.
Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
Identifying problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the supervisor, manager or director.
Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
Perform high complexity testing under the onsite supervision of a general supervisor as defined in the CLIA regulations.
Accepts other duties as assigned.