Executive / senior industry position
Prometheus Biosciences is focused on the discovery and development of therapeutics and companion diagnostics for IBD using a precision medicine approach. With an integrated, multiplatform strategy we are able to identify dominant pathways in the pathogenesis of IBD. To date this work has led to the identification of several new potential targets and drug candidates for the treatment of IBD.We seek a motivated, detail-oriented Manager, Lab Processing responsible for managing and tracking the physical receipt, storage and retrieval of samples for the clinical diagnostic laboratory.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Manage the receipt, processing, storage and retrieval of samples for commercial testing.
- Identify and label patient samples following standard operating procedures.
- Coordinate sample requests and resolve sample discrepancies with Clinical Operations and R&D.
- Coordinate lab testing of samples with Lab Operations, Clinical Operations and R&D.
- Generate worksheets for laboratory testing and ensuring the oldest samples are prioritized for testing.
- Oversee and coordinate add-on orders.
- Schedule in-house proficiency testing and oversee accessioning of internal and external samples.
- Resolve computer issues with Information Systems and patient.
- Resolve requisition deficiencies with Order Processing.
- Train personnel on accessioning functions and maintain training records.
- Conduct or oversee annual competency assessment of personnel.
- Perform weekly scheduling of accessioning staff and delegation of tasks to meet processing deadlines.
- Monitor and develop work flow and efficiency improvements in accessioning and other related activities.
- Respond to freezer alarms and coordinate material movement as required.
- Coordinate PM and refrigerator/freezer cleaning with Metrology.
- Writes or updates laboratory documents such as Standard Operating Procedures and departmental forms.
- Manage and refine existing procedure and define new procedures and SOPs related to sample handling, storage and tracking.
- Evaluate and validate automated solutions for aliquotting, bar code labeling and storing of multiple sample aliquots.
- Maintain sample handling and cold storage system. Coordinate sample disposals at designated intervals.
- Transfer residual serum to manufacturing as required.
- Maintain accessioning inventory as required and order materials as needed.
- Investigate deviations and customer complaints with QS and complete documentation to ensure compliance with SOP’s and regulatory guidelines.
- Collaborate with existing software development team to specify software and database requirements and improvements, queries and reports.
- Required to follow all safety procedures, policies and precautions.
SUPERVISORY RESPONSIBILITIES Directly supervises members of the accessioning area. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. QUALIFICATIONS A qualified individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE
- A minimum of 5 years CLIA related experience
- A minimum of 3 years managing and motivating employees in a clinical lab setting.
- Knowledge and experience with databases and Excel strongly preferred.
- Ability to effectively train laboratory individuals on all laboratory accessioning processes.
- Experience working in a FDA, GMP and ISO environment preferred.
- Experience managing multiple projects required.
LANGUAGE SKILLSAbility to read and interpret documents such as scientific publications, vendor specifications, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Strong interpersonal skills and ability to work cross functionally. Ability to understand and comply with all applicable laboratory regulated guidelines. Ability to effectively communicate and collaborate with internal and external customers. MATHEMATICAL SKILLSAbility to work with mathematical concepts up to probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to read and analyze financial data. REASONING ABILITYAbility to define problems, collect data, establish facts and draw reasonable conclusions. Ability to interpret a variety of technical instruction in mathematical or diagram form. Ability to understand and comply with all applicable laboratory regulated guidelines. Ability to understand and utilize project management tools. CERTIFICATES, LICENSES, REGISTRATIONS PHYSICAL DEMANDSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is moderate.
Some travel may be required.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.