Advance Development Tech

Yale NewHaven Health; New Haven (CT); On-site; USD 95,000 - 130,000; Full time

Job summary

Yale NewHaven Health in New Haven, CT seeks an Advanced Development Technologist to design, optimize, and validate clinical lab assays and new technology under CAP/CLIA guidelines, reporting to leadership in Special Chemistry.

You will transfer developed assays to production, prepare validation plans and training materials, analyze QC data, and contribute to regulatory readiness and ongoing assay improvements within Laboratory Medicine.

Qualifications

• Bachelor's degree in Analytical Chemistry or related field required; advanced degree preferred.
• Minimum five years of clinical or research lab experience with LC-MS/GC and CLIA/CAP context.
• ASCP certification preferred but not required.

Responsibilities

• Develop and validate new assays and technology following CAP and CLIA guidelines.
• Prepare validation plans, SOPs and training documents.
• Transfer assays/technology from development to clinical production and monitor QC post-implementation.
• Participate in regulatory readiness and continuous improvement of existing assays.

Skills

LC-MS principles

Experiment design

Data analysis

Spreadsheet design

Interpersonal skills

Organizational skills

Education

Bachelor's degree in Analytical Chemistry or related field

Advanced degree in Chemistry preferred

Tools

LC-MS (Liquid Chromatography–Mass Spectrometry)

Gas Chromatography

Job description

Overview

To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.

Under the supervision of the Clinical Chemistry Director, and reporting to the Manager and Supervisor of Special Chemistry, the Advanced Development Technologist will assist with the design, optimization and validation of clinical laboratory assays and new technology in accordance with CAP and CLIA guidelines. Responsibilities include experimental design, preparation of validation plans, SOP's and training documents. The Lead Technologist will work closely with the Laboratory Manager and supervisors to transfer assays/technology from development to clinical production. Additional responsibilities include quality review of assays post-implementation and the optimization of current assays.

EEO/AA/Disability/Veteran

Responsibilities

• 1.Performs and oversees development of new assays and technology following CAP and CLIA regulatory requirements. Understands and is able to apply basic principles of analytical chemistry, laboratory procedure, theory, and techniques; understands instrumentation and equipment and shows good judgment in using them. Works with the Clinical Chemistry Director and Laboratory Manager to identify new assays and new technologies. Writes validation summaries, SOP's and training documents according to all regulatory guidelines. Assigns priorities to clinical and assay development responsibilities to ensure new assays are implemented in a timely fashion. Demonstrates a thorough knowledge of Quality Control data assessment; documents QC and corrective actions. Monitors quality and performs optimizations as needed of assays post-implementation. Actively participates in regulatory readiness for preparations.
• 2.Provides accurate information to other team members and clinical staff as requested in an organized, courteous manner, and in a timely fashion. Able to navigate and show competency with the use of LIS applications. Can utilize the LIS to identify and track validation specimens effectively. Works with the LIS and clinical staff to design and test new assay test builds. Is proficient in data analysis software programs such as excel and EP Evaluator.
• 3.Demonstrates independence by one's ability to evaluate culture integrity, problem solving, or trouble shooting instrumentation. Assumes the role of first line troubleshooter in areas of special expertise to answer routine and complex problems. Recognizes problems related to inappropriate outcome of procedures, takes corrective action when indicated. Is able to troubleshoot issues related assay design, instrumentation or software. Able to foster a team approach to solve problems with other departments within Laboratory Medicine by cultivating an atmosphere of mutual respect.
• 4.Demonstrates professionalism at all times both in attitude and approach to work activities. Demonstrates a positive approach to learning new or existing methods, techniques and/or procedures. Accepts constructive criticism in a positive manner and takes corrective action to improve performance in problem areas. Participates in teaching lab personnel, students and lab residents following established laboratory procedures in a courteous professional manner. Always maintains a positive, respectful relationship with learner. Participates in the department?s continuing education program and documents at least 12 education credits annually. Independently researches and suggests new methods and technology Adheres to laboratory policies and procedures, hospital attendance and tardiness policies, and demonstration of mutual respect for all laboratory personnel. 4 1. Demonstrates technical competency in performing a variety of molecular testing to ensure that accurate and timely data can be provided.

Qualifications

EDUCATION

Bachelor's degree from an accredited university or college in an Analytical Chemistry or Biotechnology, Biochemistry, Toxicology, Clinical Laboratory Science or equivalent Bachelor's degree. Advanced degree in Chemistry strongly preferred.

EXPERIENCE

Minimum of five (5) years clinical or research laboratory experience using Liquid Chromatography Mass Spectrometry and/or Gas Chromatography and/or in a Clinical Chemistry or Toxicology laboratory. Previous experience in assay design/development preferred. Experience in a CLIA certified laboratory preferred.

LICENSURE

ASCP certification preferred but not required.

SPECIAL SKILLS

Strong knowledge of LC-MS principles and techniques. Ability to design and execute experiments. Efficiency in word processing applications, spreadsheet design and data analysis. Excellent customer service and interpersonal skills are required. Ability to work as a member of a diverse team is essential. Excellent organizational skills required.

PHYSICAL DEMAND

Must be able to lift and carry 15 or more pounds.

YNHHS Requisition ID

194447