Lead Biological Scientist Jobs

CSS is searching for individuals with strong science backgrounds to work as part of a team supporting the Department of Homeland Security, performing molecular diagnostic assays to detect the presence of biological agents and other infectious diseases in environmental samples. Testing is fast-paced and requires that incoming specimens are recorded, processed, and triaged appropriately while maintaining chain-of-custody associated with the specimens. Staff are trained to work in both biosafety level 2 and 3 environments and may cross-train to provide surge testing for other laboratories. Additional duties include QC, proficiency testing, equipment maintenance, disposal of biohazardous waste, and maintenance of collection apparatus. The scientist may provide laboratory support for field responses and investigations as assigned by the supervisor Working Conditions require the willingness to work under conditions of potential exposure to infectious agents; the willingness to sign a confidentiality statement upon hire; and all designated staff will undergo a security risk assessment (SRA) and renew it every three years.
General Work Description And Conditions

• Proper archiving, storage, and shipping of samples.
• Necessitates decontamination of several rooms requiring extensive use of bleach and alcohol. For safety, proper PPE is required.
• Must be present for all hours of the workday and be available 24/7/365 in case of emergency.
• Performing non-research biological science work utilizing microbiological and molecular techniques, which currently includes DNA extraction and real-time polymerase chain reaction (real-time PCR) to identify and characterize pathogenic bacterial and viral agents (analytical methods and technologies may change over the life of the contract).
• Accurately performing work with confidence
• Decontamination of workspaces, including Biological safety cabinets, hoods/air boxes, equipment, and other items associated with processing and analysis activities.
• Familiarity with Good Laboratory Practice (GLP)
• Data entry utilizing computerized or computer-linked systems
• Handling, receipt, and processing of daily operational, Quality Assurance, verification and proficiency test samples potentially containing biological threat agents.
• Maintaining documentation of records demonstrating compliance with applicable training/retraining, competencies, document reviews
• Preparing reagents and samples - same as above
• Supporting BioWatch Program logistics in conducting and documenting annual inventory (e.g., serial numbers, disposition, POs, packing slips, etc.) of DHS-procured durable equipment and property.
• Interpretation of results - must be capable of independent analysis
• Demonstrating the ability to follow and adhere to written procedures and accepted practices in accordance with federal, state, and local regulations, safety, security, and dress code policies, procedures, and guidelines, including DHS Safeguarding Sensitive but Unclassified (For Official Use Only) Information (January 2005) when visiting or working at Government facilities
• Adhering to QA/QC requirements in accordance with the Public Health Laboratory quality management systems and the BioWatch Laboratory QAPP
• May require lifting, stooping, reaching, carrying, and/or transporting equipment and/or instruments to/from different laboratory areas and/or packaging instruments for service
• Maintaining chain of custody (CoC)
• Restocking and maintaining proper inventory (e.g., par levels, rotation of stock, expiration dates, etc.) of necessary supplies.
• May require lifting, stooping, reaching, carrying, and/or storing consumables, supplies, and/or equipment of various sizes, shapes, and/or weights up to 70 lbs.
• May require collecting multiple bags from BSL-2/BSL-3 areas and loading and unloading the autoclave machine when completed. For safety, proper PPE is required.
• Laboratory work may require several PPE changes including, but not limited to, respiratory and full body protection (e.g., Tyvek suit) and gloves, for extended periods of time, not to exceed four (4) hours.
• Scheduled workdays include weekends and holidays
• Demonstrating competency in various testing methodologies (e.g., multi-center studies), evaluating potential products and processes against unique environmental backgrounds, and meeting established deadlines
• QA/QC and acceptance testing of reagents in accordance with applicable Standard Operating Procedures (SOPs) and the Laboratory Operations Quality Assurance Program Plan (QAPP)
• Preparing written and oral technical reports, answering questions, and making recommendations to the Lead Biological Scientist for inclusion in comprehensive reports
• Processing samples requires more than one (1) hour, but typically not to exceed four (4) hours, of repetitive motion (e.g., twisting/cutting/pipetting/gripping) on a regular, if not daily, basis.
• May require lifting, stooping, reaching, carrying, and/or storing biohazard waste of different sizes and/or weights up to 40 lbs.
• Laboratory workflow may occur in different laboratory areas (e.g., clean, high and low titer, under different conditions, such as BSL-2/BSL-3), utilizing a variety of biological safety cabinets (BSCs), and/or hoods (e.g., laminar or dead air).
• Samples may require being transferred from one area/cart/cooler to another, requiring staff to lift ~50-60 lbs.
• May require lifting, stooping, carrying, and/or storing of sample archives of varying sizes and weights up to 40 lbs.
• Receiving samples may require extended walking to/from laboratory areas and up and/or down several flights of stairs.
• Performing routine equipment calibration, cleaning, assembly, and maintenance in multiple lab areas
• Collecting, processing, and analyzing internal laboratory swipes/swabs for Quality Assurance/Quality Control (QA/QC) and contamination monitoring located across multiple lab areas
• Analyzing routine external QA samples in accordance with the BioWatch SOPs and QA Program guidance
• Proper disposal of bio-hazardous waste.

Note: The work schedule may include weekends to ensure laboratory staff coverage for 24/7, 365 days of operation. As part of the pre-hire process, you must submit transcript(s) for review for the Clinical Laboratory Improvement Amendments (CLIA) verification process. If selected as the preferred candidate, you must submit an official transcript from each accredited academic institution to verify the above. We will be unable to move forward with your application for this position if you do not meet CLIA qualifications.
Responsibilities

• Generating and maintaining documentation in accordance with the SOPs and QAPP
• Maintaining and documenting training/retraining and competency of all BioWatch laboratory personnel and observing staff on a quarterly basis
• Providing new personnel training/retraining on protocols/procedures for daily sample handling and internal tests (e.g., QA, PT) to enable personnel to pass 90-day Demonstration of Capability successfully (DOC) tests, proficiency tests (PTs), and/or external audits as defined in the BioWatch Laboratory QAPP
• Other duties as assigned
• In compliance with local policy and direction from the Local Laboratory Director, generating and executing corrective action plans in accordance with the BioWatch Laboratory QAPP to address any findings from audits, proficiency tests, data trend analysis, internal inspection findings, and/or other occurrences that have the potential to degrade the confidence in results generated by the laboratory
• Participating in Monthly Laboratory Operations Technical Conference Calls and other BioWatch Program-related communications, as appropriate
• Conducting Annual Performance Reviews
• Reviewing and approving timesheets
• Developing and maintaining monthly work schedules for local BioWatch laboratory personnel to cover 365-day scheduling and emergency response efforts
• Effectively communicating with the Project Manager, the government client and associated Partners, as well as the laboratory staff
• Confirming refresher training is performed following protocols updates/amendments and as required
• Interviewing and assessing candidates for open positions
• Troubleshooting technical laboratory issues in conjunction with the local Laboratory Director and/or designee and BioWatch Laboratory Operations personnel
• Supervising laboratory staff and casual surge personnel

Qualifications

• All personnel shall meet state/local accreditation requirements (e.g., Select Agent Registration, American Society of Clinical Pathologists (ASCP)) as determined by each local Laboratory Director and local safety/biosafety requirements.
• Understanding of laboratory certifications and accreditations to ensure adherence to certification and accreditation requirements to meet regulatory requirements.
• Knowledge of the concepts and theories of microbiology, immunology, molecular biology, basic microbiological, immunological, and molecular biology techniques (microbial culture techniques, biochemical tests, serology, sequencing, and nucleic acid-based detection assays).
• Demonstrated knowledge of the quality assurance practices (e.g., equipment maintenance, proficiency testing, method validation, staff competency, following standard operating procedures) specific to microbiology, immunological, and molecular biology test methods in a diagnostic setting.
• Minimum of a Ph.D. or Master's degree from an accredited university in microbiology, molecular biology, or related course work in biological sciences with at least two years of laboratory bench experience outside of an academic environment, utilizing PCR, aseptic techniques and biological assays, and at least two years of experience serving as a Senior Scientist or Team Leader of a laboratory team/project. Bachelor's degree from an accredited university requires five years of laboratory bench experience outside of an academic environment, including at least two years of experience as a Team Leader/Senior Scientist.
• Must be able to obtain/maintain a DHS Suitability security clearance

Preferred Qualifications

• Ability to follow work instructions and either work independently or in a team environment.
• Experience with concepts and theories of microbiology and molecular biology, including quantitative Real-Time PCR.
• Ability to use a computer to conduct research, oversee databases, and produce written documents.
• Effective and professional communication both verbally and in writing, and ability to prepare concise technical reports.
• Competency and demonstrated understanding of standard biosafety and biosecurity practices.
• Biological Safety Level (BSL)-3 experience is desirable.
• Knowledge of the principles and policies governing professional ethics and rules of conduct.

CSS is predominantly a Federal Contractor and is subject to following the terms of Executive Orders. CSS requires all Employees (Direct, Indirect, government, state, and commercial), including employees working from home/remotely, to be fully vaccinated against COVID-19 or have an approved exemption. Exceptions to the COVID-19 vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the CSS HR Department.
CSS is an Equal Opportunity/Affirmative Action Employer who provides equal employment opportunities to all employees and applicants for employment without regards to race, color, religion, sex, gender identity, sexual orientation, pregnancy, national origin, age, disability, veteran status or genetic information. In addition to federal law requirements, CSS complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.