This position is responsible for leading the clinical assay development, optimization, validation and verification work in a CAP/CLIA certified lab. This person must have strong problem solving skills, extensive knowledge and technical expertise to design and implement clinical assays, clear understanding and good laboratory practices from assay development to clinical implementation of the assays according to CAP/CLIA requirements. The Sr Assay Development Scientist is also expected to work independently, handle multiple projects concurrently, engage in scholarly activity, and contribute new knowledge in Pediatric Pathology and Laboratory Medicine. In addition, this position will provide guidance and day-to-day supervision to the assay development team. Actively promotes a Lean work culture by performing team member duties to ensure consistent use of Lean principles and processes and continuous process improvement.
Molecular or metabolic analytical methods required
Assay development and validation required
Leadership role in identifying scientific solutions required
Strong technical expertise in molecular techniques required
Introduction of new diagnostic assays to clinical bench preferred
Genomic data analysis preferred
Next-Generation sequencing preferred
Graduate or professional work or advanced degree; or equivalent experience required
Requires depth within a specialized, critical discipline and/or breadth of substantive professional knowledge that crosses disciplines within the professional field
Interprets internal/external business challenges and recommends best practices to improve products, processes or services
May lead functional teams or projects with moderate resource requirements, risk, and /or complexity
Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgment and identify innovative solutions
Impacts the achievement of customer, operational, project or service objectives; work is guided by functional policies
Works independently, with guidance in only the most complex situations
Communicates difficult concepts and negotiates with others to adopt a different point of view
JOB SPECIFIC RESPONSIBILITIES:
Direct activities of assay development specialists toward achieving project objectives and provide technical leadership and guidance to the assay development team. Perform clinical assay design, development, optimization, validation, verification, and result evaluation with autonomy. Work with laboratory director, manager, and assay development team to improve protocols, evaluate new techniques, and develop strategies for their implementation. Record data and maintain current and accurate laboratory notebook. Report findings and updates to Manager and Clinical Consultant, and as needed to other physicians. Prepare and maintain SOPs for processes and instruments. Assist with preparation of the laboratory to comply with regulatory guidelines. Understand and adhere to Lean principles and process such as standard work and maintaining 5S concept in work area realizing that all processes are driven by the needs of the customer. Using an awareness of how the work performed is valued by the customer, perform duties, make decisions, take actions and continually strive to improve work processes. Establish and maintain close working relationships with colleagues, manager, and medical director.
Maintain current knowledge of related literature in clinical assays. Assist in writing publications results. Align daily work with individual, section, departmental and organizational goals and objectives. Actively looks for ways to improve standard work processes and shares insights to that end with team members with the same level of importance as performing quality technical work. Promote teamwork and cooperation through helpful, courteous, and positive interactions with colleagues. Promote a trusting and secure work environment through supportive, dependable interactions. Take ownership of performance and PEAC process by understanding lab goals and objectives and align individual activities with hospital and lab goals and objectives.
Insure adequate reagent and supply inventory needed for assay development, optimization, validation, and verification through application of Lean principles. Maintain a clean, safe, orderly work environment. Perform regular cleaning, maintenance, calibration and quality control of equipment and methods to ensure accurate and reproducible results. Troubleshoot equipment and assay problems as appropriate. Maintain inspection readiness. Demonstrate knowledge and ownership of current inspection requirements for all applicable regulatory and accrediting agencies relating to area of responsibility. Participate in tracers, mock inspections, regulatory reviews and Quality Assurance meetings, and help with other duties as required. Attend and participate in stand up meetings, staff meetings and Laboratory Town Hall meetings.
"Share knowledge and provide instructions to new employees, students, specialists, and other staff and participate in training of said individuals. Pursue continuing education. Assist in writing publication as required. Perform other duties and special projects as requested. Read and adhere to all laboratory policies and procedures pertaining to section and document understanding of such.”
Specific Knowledge, Skills and Abilities:
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures.
Use appropriate interpersonal styles to establish effective relationships with customers and internal partners; interact with others in a way that promotes openness and trust and gives them confidence in one's intentions.
Meet patient and patient family needs; take responsibility for a patient's safety, satisfaction, and clinical outcomes; use appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence.
Ensure that the customer perspective is a driving force behind business decisions and activities; craft and implement service practices that meet customers' and own organization's needs.
Develop and use collaborative relationships to facilitate the accomplishment of work goals.
Identify and understand issues, problems, and opportunities; compare data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
Take prompt action to accomplish objectives; take action to achieve goals beyond what is required; be proactive.
Deal effectively with others in an antagonistic situation; use appropriate interpersonal styles and methods to reduce tension or conflict between two or more people.
Effectively manage one's time and resources to ensure that work is completed efficiently.
Accomplish tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.
Set high standards of performance for self and others; assume responsibility and accountability for successfully completing assignments or tasks; self impose standards of excellence rather than having standards imposed.
Assimilate and apply new job-related information in a timely manner.
Clearly convey information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
Light - Exerting up to 20 lbs. occasionally, 10 lbs. frequently, or negligible amounts constantly and may require walking or standing to a significant degree.