Molecular Manufacturing Technologist (1st Shift)

Position Summary The Molecular Manufacturing Technologist is responsible for performing high complexity molecular techniques that include, but are not limited to, cell culture, control and reagent manufacturing, nucleic acid extractions, and next generation sequencing (NGS). This role works independently with minimal supervision and provides technical expertise in assigned workflows and contributes to document revision and process improvements. The Molecular Manufacturing Technologist may participate in troubleshooting, method validation, and manufacturing training efforts, ensuring operational excellence and data integrity across Molecular Manufacturing workflows. This position works under the direction of the Molecular Manufacturing Operations leadership team and follows standard laboratory procedures and policies. Job 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. Required Qualifications 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. Preferred Qualifications 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. Physical Demands Will work at a computer that requires the use of copiers and PDF scanners. Visual acuity and analytical skills to distinguish fine detail. Ability to pass a visual color discrimination test. Manual dexterity to use common laboratory equipment and perform sterile techniques as required. Must possess ability to sit and/or stand for long periods of time. Must possess ability to perform repetitive motion. Ability to lift up to 30 pounds. May be required to handle and/or may have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and bio-hazardous material/chemicals including formaldehyde, Vesphene, Clorox bleach, Diaminobenzidine (DAB) and alcohol, which emit fumes. Formaldehyde and DAB are carcinogenic. Required Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other This position may require evenings/nights, weekends and Holidays. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check (applicable for certain positions) and reference verification. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. #J-18808-Ljbffr Caris Life Sciences