Sweta Singh

• Drive and support a high-performance, quality centric, production-minded positive work environment following CLIA/CAP regulatory requirements.
• Direct and coordinate high-volume sample and testing workflows for clinical samples, clinical trial samples and biopharmaceutical/research samples to achieve expected TAT, drive patient care and meet revenue goals.
• Oversee laboratory staff in different departments, daily scheduling, project prioritization, inventory control, capacity planning, laboratory training, competency, QC monitoring, Proficiency testing.
• Establish key performance indicators to measure success of initiatives, driving accountability within teams and laboratory.
• Develop and train personnel within the laboratory and complete reviews and appraisals of their performance.
• Establish laboratory organization plan and delegate responsibilities, authorities and accountabilities to appropriate subordinates.
• Spearhead activities for new department launches, validations, and product launches in NGS, Anatomic Pathology, Flow Cytometry, Reagent Manufacturing, Accessioning areas.
• Manage cross-functional teams for multiple large-scale projects, ensuring successful completion on time and within budget constraints.
• Spearhead and support LIMS process optimization projects resulting in improved workflow efficiency and sample management.
• Lab Operations lead to drive study specific plan generation, set deliverables, timelines and coordinate testing for clinical trial, biopharma, and research studies.
• Lead and support standardization of clinical and biopharma workflows across different sites of the organization.
• Provide workflow-related technical guidance to group members and communicate workflow insights to the Product Development team.
• Ensure all laboratory activities and operations are carried out in alignment with Quality Management System (QMS) and comply with local, state, federal, and governmental regulations and laws.

GENERAL RESPONSIBILITIES:

• Global project management activities: provided leadership, coordination and management of the PMO process and functions.
• Led and motivated cross-functional, usually multi-site teams for one or multiple projects representing all Product Development life-cycle phases including project planning, scheduling, tracking, coordinating, and monitoring activities.
• Created and managed project scope and schedule of complex development projects
• Identified needed decisions and drove the decision-making process.
• Scheduled and led regular meetings to coordinate inter-departmental project activities; including those necessary to resolve project issues.
• Facilitated the exchange of information between departments on a day-to-day basis and maintained liaison with all members of the project team between project team meetings.
• Produced and presented clear, concise and professionally written communications and presentations for internal stakeholders.
• Managed project communications to all stakeholders (project teams, functional managers, internal customers, and senior management), including meeting minutes, monthly updates, communications meetings, and phase reviews

KEY ACHIEVEMENTS:

• Led Implementation of a multi-million dollar initiative to create an end-to-end LIMS solution for sample management and tracking, NextGen sequencing workflows, customer portal for report distribution, commercial and biopharma billing; reagent and equipment management.
• PMO lead on Company's Quality Plan encompassing QSR, QMS, ISO 38450.
• Led million dollar specimen acquisition activities with domestic and international vendors to support analytical and clinical validation activities for MolDX submissions for multiple cancer indications.
• Led cross-functional teams to successful MolDx submissions for MRD assays.
• Managed project status for internal, research and Biopharma projects across multiple lab sites.
• Supported implementation of capacity and resource management pipelines to identify restraints and bottlenecks.

• Define pre-analytical, analytical and post-analytical laboratory workflows as per CLIA and state requirements.
• Ensure accurate and timely movement of incoming patient specimens through defined pre-analytical, analytical and post-analytical workflows.
• Selection of appropriate test methodology for clinical use followed by validation/verification of new test performance characteristics including the reportable range, precision, and accuracy
• Review and release patient results. Reported results to appropriate state departments via phone calls, fax, flat files and other approved methods.
• Establish a quality control program appropriate for the testing performed and ensuring maintenance of acceptable levels of analytical performance throughout the entire testing process.
• Establish Quality Management System as per CLIA and CAP guidelines and write quality manuals and lab policies.
• Monitored Key Quality Indicators including turn-around-times, rejected samples, throughput, critical value reporting, customer satisfaction, corrected reports, etc.
• Generated statistical data: positive control statistics, positive result statistic, result reporting statistics.
• Prepared for CAP biannual on-site inspection and self-inspections.
• Managed laboratory personnel, including hiring, performance evaluation, disciplinary action, orientation, training and competency assessments.
• Identification and enrollment in appropriate PT programs for validated tests.
• Management of daily laboratory resource allocations, budget management, instrument PM and calibration schedule.
• Identified quality issues and addressed them with corrective actions and CAPAs.
• Maintained company's CLIA, CAP, GA business license. Also responsible for obtaining, maintaining and renewing out-of-state testing licenses.
• Coordinated and provided support to accounting team with respect to company expenses and budgeting.
• Identified key test components to design test requisition forms, marketing materials and the LIMS system.
• Validated and established performance specifications for multiplex RT-qPCR assays, for detection of respiratory pathogens, and ELISA assays.
• Performed initial clinical utility and analytical testing on new medical devices, e.g.: semi or fully automated extraction systems, real-time PCR equipment. Several equipment were successfully introduced in the US market with a steadily increasing customer base for the purpose of COVID-19 testing.
• Trained and provided resources to the technical support team for new medical devices and assays.

• Designed quality control programs and trained personnel to ensure all procedures follow quality policies.
• Reviewed and troubleshot all test results and released patient test reports.
• Trained new lab staff in all assays, lab policies and CLIA/CAP/OSHA guidelines.
• Coordinated with assay validation team to perform new test validations and desiged procedures to optimize existing processes.
• Reduced turnaround time for patient test result reporting to 24-48 hours from a previously offered 5-7 business days.
• Re-evaluated lab resources and optimized lab performance with minimal personnel and expenditure requirement.
• Worked with IT team and LIMS vendors to re-configure lab LIS software to improve test kit tracking procedures, accessioning processes, automate result entry and reporting process for all test platforms.
• Established new procedure to effectively track patient samples with missing information and communicate updates between the lab and customer service department.
• Introduced new methodologies to automate lab tests.
• Worked with IT, marketing and research team to re-define and upgrade test menu, reports, requisition forms and marketing materials.
• Introduced lab document control process using Medialab.
• Extensive experience writing SOPs, Quality Management policies, compliance documents, validations, marketing materials and technical papers.

• MB/MT (ASCP) certified.
• Worked closely with R&D on validation of new diagnostic platforms-Biofire (Gastrointestinal Panel & Respiratory Pathogen Panel), Quant studio (antibiotic resistance), ARIES (C. difficile), Luminex (gene markers for pathogenic bacteria), MagMAX (high throughput DNA extraction).
• Performed routine analysis on patient samples using molecular biology, microbiology and immunology techniques. Involved testing of different bacteria, fungi, parasites, health risk markers.
• Performed instrument calibration and troubleshooting.
• Supported development of quality control policies/procedures, new assay techinical SOPs, and LIMS design.
• Generated inventory and closely worked with purchasing department for lab order and supplies.
• Health and Safety Officer: Performed general safety and fire- safety inspection and audits. Organized necessary training needed to maintain safe-work environment. Directly involved in policy development and implementation.

• Synthesized Glycoenzyme using E.coli expression system.
• Developed methods to synthesize highly pure sugar nucleotides.
• Designed and implemented separation and analytical techniques to scale-up sugar nucleotide production process at high purity.
• Developed SOPs, COAs for the company product-line and supported development of Company Product catalog and Brochure.
• Represented Chemily Glycoscience at Conferences organized by American Society of Chemistry (ACS) and International Carbohydrate Symposium (ICS).

• Held weekly recitation class to review material taught in class, and clarify doubts.
• Held Exam-review sessions, and involved in grading midterms and final exams.
• Organized class material, quizzes, and recitation material to make them available through online interfaces like Learning Catalytics, Mastering Biology and Piazza.
• Aided the professors in assessing student performances, and discussed ideas to improve upon the teaching process.
• Held lectures for certain topics

• Worked under Dr. Kirill Lobachev on several projects and helped with the normal day-to-day functioning of the lab
• Project: Studied the deleterious effects of triple nucleotide repeats, specifically GAA/TTC repeats associated with Friedreich ataxia, which are vulnerable targets for Double strand breaks (DBS) and Gross chromosomal rearrangements, thus resulting in genomic instability. Investigated mutation rates as a result of the triple repeats in yeast using molecular genetics techniques like PCR, Electrophoresis, Southern blotting, DNA extraction, Transformations, Fluctuation assays, plasmid preparation, restriction digestions etc. Interpreted research findings and summarized data into reports.