Director of Laboratory Informatics – (250002V5)

Overview

The Massachusetts Department of Public Health (DPH) seeks an experienced leader to serve as our Director of Laboratory Informatics. The Director of Laboratory Informatics position for the State Public Health Laboratory (SPHL) has authority from the SPHL Director to carry out functions of Laboratory informatics described and serves as the senior scientific and Laboratory manager responsible for the SPHL’s strategic direction for its Laboratory Information Management System (LIMS), Health Information Exchange, and data security and retention. This position will utilize modern information science and technology as a strategic tool to verify laboratory electronic processes and data compliance to promote public health. The Director of Laboratory Informatics is responsible for ensuring that the interests of the SPHL and that of the LIMS are aligned with the Centers for Disease Control and Prevention’s (CDC’s) national health information technology standards, architecture, and information technology specifically in the areas of electronic messaging and interoperability, as well as laboratory specimen/sample processing, testing workflows, data analysis and result reporting, following CLIA, ISO17025, or other regulatory requirements of the MA SPHL. This position will oversee the electronic management of samples, laboratory data, automated workflows and instrument integration throughout the laboratory and the development and distribution of laboratory information to associated statewide customers through Electronic Laboratory Reporting and will ensure that regulatory requirements for the SPHL LIMS are met and documented during periodic entity audits by CLIA, A2LA for ISO17025: Food and Drug Administration (FDA); Department of Environmental Protection (DEP) and other Federal and state regulations governing clinical and public health Laboratories and as the primary Laboratory Privacy Liaison to report incidents to the DPH Privacy and Security Office with regular consultation with the SPHL Division Director of Quality Assurance. This position will be required to ensure that the security of SPHL’s laboratory data related to key federal programs within CDC and Department of Homeland Security (DHS) are maintained on behalf of the SPHL Director/Responsible Official and in coordination with the Executive Office of Health and Human Services (EHS) IT staff.

Learn more about what it’s like to work at the Bureau of Infectious Disease and Laboratory Sciences.

Duties and Responsibilities (these duties are a general summary and not all inclusive):

• Serve as the Laboratory Data Custodian and grant network access to Laboratory staff to Laboratory network directories and user groups to maintain Protected Health Information (PHI) privacy and confidentiality and prevent unauthorized disclosures.  This includes management and auditing of network access and usage, including security group assignment, and reporting to the SPHL Laboratory Director/Associate Director. Supervise the Laboratory LIMS ELR Administrator and ensure appropriate ELR user access is granted per CLIA, DOJ, FDA, DHS or other regulatory authority including provision of ELR user support and training. Write Standard Operating Procedures (SOPs) as needed for approval by the SPHL Director. Monitor Compliance with internal LIMS training. Serve as the Laboratory primary point of contact regarding all ELR issues for MassIT and EHS IT.
• Confirm integrity of reported data across LIMS, ELR, and thru the VPN tunnel to comply with CLIA and other regulatory agencies.  Collaborate with CDC and lab staff to ensure that the laboratory test result data reported matches the data received via applications such as PHIN-MS, PHLIP, and ALRN monthly reports.
• Act as the primary laboratory point of contact to collaborate with EHS IT and MassIT network and desktop support staff to ensure that all networked laboratory instrumentation and laboratory applications meet national laboratory standards for federal programs such as SPHERES, ARLN, and PulseNet, as well as EHS IT and MassIT Architecture and Security requirements.
• Oversee laboratory elements of ELR integration and interoperability efforts, including messaging between LIMS, MAVEN, CDC and other hospitals and health care providers.  Provide input on the proper selection of Laboratory LOINC and SNOMED.
• Serve as the BIDLS Public Health Laboratory (PHL) interoperability data specialist and in regular consultations with the SPHL Director, lead all laboratory components of Laboratory HL7 messaging, working with EHS-IT.
• Oversee data security of PHI and Personally Identifiable Information (PII) and administration of applicable data use and data retention policies. Includes collaboration with EHS-IT on use of on premises servers and analysis stations and use of all cloud-based infrastructure for Laboratory-specific applications to ensure security and data integrity and compliance.
• Under the direct supervision of the MA SPHL Director and indirect supervision of the Associate Laboratory Director, collaborates with all Laboratory Division Directors, and other BIDLS Division Directors, DPH health programs, and external partners as needed to apply for and meet the requirements of various grants.  Collaborate with internal and external partners to implement grant-funded activities, attending meetings/conferences as needed according to the requirements of the funding. Collaborate with other state public health and environmental laboratories and Association of Public Health Laboratories to share informatics expertise. Assist in the preparation of annual goals and objectives and operational budgets.
• May be required to perform other duties as needed, include functions in support of emergency declaration activities.

Preferred Qualifications:

• Clinical laboratory knowledge of testing processes in microbiology, diagnostic immunology, Chemistry and/or molecular diagnostics.
• Technical expertise and educational background to coordinate all aspects of a comprehensive Laboratory Information Management System for a public health laboratory including components of bioinformatics, informatics, and laboratory/clinical experience.
• Experience working in a laboratory setting, preferably a public health environment.
• Working knowledge of chemistry, virology, and microbiology laboratory tests and techniques as well as public health and epidemiology.
• Working knowledge of laboratory information management systems (LIMS) including applications that support sample kit management, sample accessioning, sample analysis, result reporting, QA/QC, inventory and management/statistical reporting.
• Experience with gathering business requirements, familiarity with system development life cycle (SDLC), networking a broad range of laboratory instrumentation, HIPAA security requirements, and data back-up solutions.
• Awareness of Specific LIMS platforms, including but not limited to LabWare, StarLIMs, OpenELis.
• Experience with and/or knowledge of HL7 messaging and LOINC and SNOMED Coding Standards.
• A proven track record successfully facilitating collaboration between end users and technical staff of varying technical aptitudes.
• Ability to keep up with current regulations and develop policies and procedures to comply with any changes.
• Knowledge of CLIA, CAP, and ISO regulations for laboratory quality assurance and quality control for high complexity testing.
• Awareness of the principles and practices of organizational behavior.
• Understanding of the principles and practices of budgeting as it relates to program management.
• Knowledge of the principles and practices of personnel management and supervision.
• Capability to select and develop staff by utilizing participatory management, personnel assessment and performance review.
• Power to give written and oral instructions in a precise, understanding manner.
• Ability to resolve personnel conflicts effectively.
• Means to delegate authority effectively.
• Potential to anticipate and analyze difficult situations and take corrective action to prevent problems from occurring.
• Skilled to supervise, including planning and assigning work according to the nature of the job to be accomplished and the capabilities of subordinates and available resources; controlling work through periodic reviews and/or evaluations; determining subordinates to work effectively; determining the need for disciplinary action and either recommending or initiating disciplinary action.
• Ability to effectively write scientific proposals, grants and manuscripts.
• At least 6 years of relevant laboratory experience including knowledge of instrumentation, study design, method development, data interpretation and Laboratory Information Management Systems (LIMS).
• At least 3 years of technical and supervisory experience to direct and manage all aspects of a comprehensive Laboratory Information Management System (LIMS) for a public health laboratory including components of bioinformatics, and clinical laboratory experience.

Special Requirements:

• Current & valid clearance for the Select Agent registration via the Department of Justice.
• Current & valid certification as a general supervisor required by CLIA, CAP, ISO15189, ISO17025 or other.

As part of the pre-hire process, you will be required to submit transcript(s) for review for the Clinical Laboratory Improvement Amendments (CLIA) verification process. If selected as the preferred candidate, you will be required to submit an official transcript from each accredited academic institution to verify the above. Please note that we will be unable to move forward with your application for this position if you do not meet CLIA qualifications.

This position will require work in the BSL-3 laboratory. In the context of work in a BSL-3 environment the successful candidate must understand the following:

• All Tier 1 Staff will undergo a security risk assessment (SRA), which includes signing a confidentiality statement, and renewal every three years.
• Working conditions include potential exposure to infectious agents.
• All Tier 1 designated staff who may be exposed to Tier 1 Biological Select Agents and Toxins (BSAT) must complete OSHA Respirator Medical Evaluation Questionnaire (29 CFR 1910.134 Appendix C), be evaluated and determined able to wear a respirator before working in any HSLI laboratory (Tier 1, non Tier1, and non SAT) that requires a respirator.
• All Tier 1 designated staff are subject to ongoing suitability assessment to ensure compliance with federal regulations regarding Tier 1 Select Agents. Failure to pass the SRA and/or suitability assessment required for access to Tier 1 BSAT may result in being laid off if no other resolution is reached.

About the Bureau of Infectious Disease and Laboratory Sciences (BIDLS):

The DPH Bureau of Infectious Disease and Laboratory Sciences (BIDLS), predominantly located in Jamaica Plain, provides public health response to infectious disease. These services include programmatic and epidemiologic response, as well as laboratory testing through the State Public Health Laboratory (SPHL).

Infectious disease response services address concerns of the general public as well as those disproportionately affected by infectious disease through a variety of risk factors. BIDLS administers ongoing disease reporting for over 90 reportable diseases in the state. Disease reporting review and follow-up with clinical providers and local boards of health is a central function of the bureau. Surveillance activity is complemented by an extensive contracted service system. These services are funded through state and federal resources and include prevention education, community outreach screening for infectious disease, immunization services, health service navigation, medical case management, insurance enrollment, housing assistance, and referral and linkage to infectious disease treatment.

The SPHL provides scientific expertise and capacity to identify infectious agents, chemical agents, and other toxins that cause human disease.  The SPHL is an active partner in joint activities with other bureaus/agencies such as environmental health, food and drug, agriculture, disease prevention and health promotion programs, and public safety.  The SPHL is a reference laboratory of the national Laboratory Response Network (LRN) and is a U.S. Centers for Disease Control and Prevention (CDC) Select Agent laboratory. SPHL staff work closely with laboratory and disease prevention programs at the CDC, and partners with the U.S. Department of Homeland Security (DHS).

BIDLS Vision:  Optimize the health of all people in Massachusetts and implement an equitable and just public health response by combatting infections and other public health threats.

BIDLS Mission: Use testing, analytical, and direct service capacities, grounded in data-, science-, and equity-driven public health principles, to share accurate information, provide timely guidance, and respond to infections and other public health threats, leveraging innovation and partnerships at the individual, family, community, and population levels.

DPH Mission and Vision:

The mission of the Massachusetts Department of Public Health (DPH) is to promote and protect health and wellness and prevent injury and illness for all people, prioritizing racial equity in health by improving equitable access to quality public health and health care services and partnering with communities most impacted by health inequities and structural racism.

We envision a Commonwealth with an equitable and just public health system that supports optimal well-being for all people in Massachusetts, centering those with systemically and culturally oppressed identities and circumstances.

Learn more and share a one-pager on DPH and what we do: DPH at a Glance PDF | Doc

Pre-Hire Process:

A tax & background check will be completed on the recommended candidate as required by the regulations set forth by the Human Resources Division prior to the candidate being hired.

Education, licensure, and certifications will be verified in accordance with the Human Resources Division’s Hiring Guidelines.

Education and license/certification information provided by the selected candidate(s) is subject to the Massachusetts Public Records Law and may be published on the Commonwealth’s website.

If you require assistance with the application/interview process and would like to request an ADA accommodation, please click on the link and complete the  ADA Reasonable Accommodation Request Form

For questions regarding this requisition, please contact the Executive Office of Health and Human Services Human Resources at 1-800- 510-4122 Ext. #4

Qualifications

MINIMUM ENTRANCE REQUIREMENTS:

Applicants must have at least (A) six (6) years of full-time or, equivalent part-time, professional, administrative, supervisory, or managerial experience in a particular specialty (i.e. scientific, professional, or technical) and must possess current license and/or registration requirements established for the performance of the position, of which (B) at least two (2) years must have been in a project management, supervisory or managerial capacity or (C) any equivalent combination of the required experience and substitutions below.

Substitutions:

I. A certificate in a relevant or related field may be substituted for one (1) year of the required (A) experience.

II. A Bachelor’s degree in a related field may be substituted for two (2) years of the required (A) experience.

III. A Graduate degree or higher in a related field may be substituted for three (3) years of the required (A) experience.

IV. A Doctorate degree in a related field may be substituted for four (4) years of the required (A) experience.

Salary placement is determined by a combination of factors, including the candidate’s years of directly related experience and education, and alignment with our internal compensation structure as set forth by the Human Resources Division’s Hiring Guidelines. For all bargaining unit positions (non-management), compensation is subject to the salary provisions outlined in the applicable collective bargaining agreement and will apply to placement within the appropriate salary range.

Comprehensive Benefits

When you embark on a career with the Commonwealth, you are offered an outstanding suite of employee benefits that add to the overall value of your compensation package. We take pride in providing a work experience that supports you, your loved ones, and your future.

Want the specifics? Explore our Employee Benefits and Rewards!

An Equal Opportunity / Affirmative Action Employer.  Females, minorities, veterans, and persons with disabilities are strongly encouraged to apply.

The Commonwealth is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law.  Research suggests that qualified women, Black, Indigenous, and Persons of Color (BIPOC) may self-select out of opportunities if they don’t meet 100% of the job requirements.  We encourage individuals who believe they have the skills necessary to thrive to apply for this role.

Official Title: Program Manager Specialist VII

Primary Location: United States-Massachusetts-Boston-305 South Street

Job: Laboratory Services

Agency: Department of Public Health

Schedule: Full-time

Shift: Day

Job Posting: Mar 17, 2025, 11:23:06 AM

Number of Openings: 1

Salary: 98,861.85 – 152,480.35 Yearly

If you have Diversity, Affirmative Action or Equal Employment Opportunity questions or need a Reasonable Accommodation, please contact Diversity Officer / ADA Coordinator: Luciana M. Hayner / Luciana.M.Hayner@mass.gov – 8573981891

Bargaining Unit: M99-Managers (EXE)

Confidential: No

Potentially Eligible for a Hybrid Work Schedule: Yes