Schedule: Monday-Friday 0800-1700with other shifts as needed

Location/Dept.: Woodward/Assay Development

Hourly/Salary:Salary

JOB SUMMARY:

Responsible for all aspects of research, development and implementation of new technology, procedures and platforms for diagnostic testing for assigned projects. Maintain advanced understanding and serve as a resource in areas utilizing complex testing. Meets all academic and productivity goals as defined in Essential Functions as described below.

ESSENTIAL FUNCTIONS:

ASSAY DEVELOPMENT

1. Researches, evaluates, and develops new assay technology and/or assay improvements for assigned projects in collaboration with medical and scientific directors and technologists.
   1. Research and develop assay protocols upon approval by Medical Director or Technical Director.
   2. Plan and perform assay validation.
   3. Present cost analysis
   4. Draft SOP for departmental approval.
   5. Complete and submit IT System change request.
   6. Complete projects within expected deadlines.
   7. Ability to work on three or more projects simultaneously.
2. Carries out laboratory projects that include feasibility studies, new product evaluation/testing, and workflow analysis.
3. Maintains an advanced understanding of various diagnostic strategies (molecular, proteomic, biochemistry).
4. Submit one abstract or poster annually, or present educational lecture for internal staff, conference, or medical/MLS school.
5. Provides training and helps with problem resolution as needed regarding testing.
6. Contributes to responses to accreditation and regulatory bodies and prepares for inspections.
7. Assists in the creation and review of clinical education and training material (procedures, technical communication, and presentations) as needed for students as well as internal and external customers.
8. Assists Manager, Director, or Medical/Technical Director with quality assurance programs regarding development to ensure that quality standards are met. Demonstrates ability to constantly improve quality standards.
9. Maintains effective communication and coordination with other departments within the organization and with external clients.
10. Actively supports and implements department procedures, policies, and strategies to achieve the corporate vision, values, and strategic plans. Helps ensure compliance with established policies and procedures, professional standards and practices, and requirements.

TECHNICAL:

11 . Serves as a technical resource for all testing sites in area or discipline(s).

12 . Researches and resolves problems and/or provides guidance and counsel to others in resolving problems appropriately.

13 . Consults with and makes recommendations to supervisor, manager, or pathologist/medical director regarding difficult analyses, abnormal findings or conflicting results.

14. Participates in developing and implementing computer system improvements for computer systems that include existing systems, middleware and new systems. Works with Information Technology department to ensure computer file maintenance for relevant assays is correct and up to date. Develops new procedures and special reports as needed.

15 . Successfully performs appropriate tests in the section as required based on company need.

16. Actively participates in technical workgroups and communication of changes.

17. As assigned, performs cost accounting exercises for current testing.

QUALITY ASSURANCE/QUALITY CONTROL:

18. Makes recommendations to management and/or Pathologist or their designee based on results of QC analysis.

19. Participates in quality initiatives for section assuring compliance with the provisions of regulatory agencies

20. Serves as a resource and advisor for QA/QC problem situations; works to resolve situations as they occur.

COMPLIANCE:

21. Research, develop, implement, maintain and document standard laboratory procedures.

22. Participate in on-site inspections by regulatory agencies.

23. Research and interpret regulations to help ensure laboratory remains in compliance at all times.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

MINIMUM EDUCATION

Meet one of the following:

• Bachelor of Science in Medical Technology, Clinical Laboratory Science or chemical, physical, or biological science
• Master's degree in Medical Technology, Clinical Laboratory Science or chemical, physical, or biological science.
• For Histology only - High School diploma or equivalent plus ASCP HT or equivalent certification

MINIMUM EXPERIENCE

• Bachelor's degree must have three (3 ) years development and/or clinical experience in complex testing techniques.
• Master's degree must have one (1 ) year development and/or clinical experience in complex testing techniques.

OTHER REQUIREMENTS:

• Relevant ASCP Technologist/Scientist certification or equivalent.

PREFERRED:

• Experience in Infectious Disease
• Familiarity with validation/verification process
• Experience with statistical and data analysis
• Good organizational skills

IMMUNIZATION REQUIREMENTS:

Prove immunity to Hepatitis B, be immunized, or sign a waiver refusing hepatitis Immunization. Provide documentation of a PPD test conducted not more than 90 days prior to date of hire or have a PPD test conducted.

GENERAL REQUIREMENTS:

1. Handles hazardous materials and wastes in accordance with safety procedures and regulations.
2. Ensure proper communication through appropriate channels.
3. Skilled in data and statistical analysis methodologies related to the medical sciences
4. Effective time management skills. Ability to manage multiple priorities and to work in a high productivity / high stress environment.
5. Ability to deal with difficult and sensitive situations with excellent customer service skills.
6. Excellent problem- solving skills/reasoning ability required.
7. Ability to make difficult or complex decisions without established guidelines.
8. Ability to work effectively in a team environment and to develop and maintain a climate of open communication and teamwork within the department.
9. Strong communication/interpersonal skills with both internal and external customers.
10. Intermediate to advanced PC Skills