• Reviews, interprets, and signs out cases based on the results of comprehensive coagulation panels.
• Identify and understand regulatory requirements to ensure the laboratory complies with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP, COLA, and NYS DOH and other requirements and regulations for states in which the lab is licensed
• Be responsible for the overall Standard Operating Procedure (SOP) management, proficiency testing review, and corrective actions.
• Defines and monitors the laboratory’s Quality Management Program.
• Answer inquiries of a technical and scientific nature for physicians, scientists, and laboratory personnel to assist with proper test requests and understanding of interpreted results.
• Assists with the planning and implementation of the quality control and quality assurance programs.
• Coordinates with Assistant Director and/or Supervisor to implement quality improvement initiatives.
• Diagnose diseases or study medical conditions using techniques such as clinical chemistry, immunology, molecular biology, and specific coagulation assays.
• Keeps current with medical knowledge as it relates to coagulation disorders and can use all relevant information resources to acquire and evaluate evidence-based information.
• Develop/implement new or revised laboratory tests/methods that make testing more cost-effective or accurate, and improve efficiency.
• Review literature and upgrade testing procedures that support current laboratory concepts.

Skills: Coagulation Analysis, Regulatory Compliance, SOP Management, Quality Oversight, Technical Consultation, QA Programs, Method Development, Evidence Evaluation

• Helps the General Manager to achieve the KPIs and objectives established for the site.
• Helps to ensure services are performed in accordance with federal and local regulations.
• Accountable for the delivery of product test data to achieve Client Satisfaction by maintaining production and specified turnaround targets.
• Monitors production of each department and ensures optimum staff levels/shifts to achieve the Company’s standards for production, quality, and financial performance.
• Reports turnaround times in monthly reports, manages to goal of 100% on time delivery.
• Monitors man-hours and approves overtime accordingly, adding additional staff where workload and financial performance can support it.
• Monitors and reports weekly projection status (#samples processed/personnel).
• Maintains production targets and takes proactive measures to sustain these targets.
• Meet with customers to determine opportunities.
• Promote the image, capability, and integrity of the company to the clients.
• Achieve and exceed key operational KPIs.
• Comply with the Company’s Code of Integrity and Professional Conduct.
• Accountable for the Health, Safety, and Environment of personnel and the enforcement of all regulations as per the Company Health and Safety Manual, and the immediate reporting of any health, safety, or environmental incidents, accidents, or concerns to the Manager/Supervisor and H&S department for action.
• Lead team to a zero recordable and near-miss incident approach.

Skills: KPI Management, Regulatory Compliance, Client Delivery, Production Oversight, Workforce Planning, Customer Engagement, Operational Excellence, Safety Leadership

• Be responsible for the overall business results of the laboratory and service area.
• Source and win new business, attracting and retaining people, managing finances and operations, and assuring compliance with governing agencies and client specifications.
• Have a broad diversity of experiences in biotech and pharmaceutical laboratory management.
• Set strategic direction for the Practice, including short- and long-term goals.
• Develop business by establishing and maintaining positive relationships with new and existing clients.
• Support the attraction, hiring, development, and retention of skilled resources for the delivery of services
• Manage and maintain revenue and profitability on an annual basis
• Manage service execution by providing subject matter expertise, overseeing employee productivity and quality, and providing hands-on support

Skills: Business Leadership, Client Development, Strategic Planning, Talent Management, Financial Oversight, Service Execution, Operational Expertise, Biotech Management

• Build and drive a culture of accountability and consistency
• Ensure all departments within R&T are compliant and adhere to all J&J and external standards or policies, including the needs of Environmental, Health, and Safety requirements.
• Drive a team responsible for the logistics of all sites, including asset management, project management, scheduling, resource planning, sample ordering and shipping, and training for the overall R&T organization.
• Build and drive a strategy to digitize the laboratory operations and execution to broaden access to data across the organization and improve the speed of performing work.
• Lead a team of lab supervisors and technicians to complete and document testing conducted for all programs
• Be responsible for efficiently running all test laboratories by keeping equipment updated, calibrated, and validated, as well as ensuring repairs and preventative maintenance are completed
• Build and drive a culture of collaboration with cross-functional partners
• Ensure that Research and Development will have the space and ability to work on test method development or early concept evaluation.
• Build and implement operational strategies for R&T in partnership with other leaders (Budget, Resources, Governance Process, Communication Plan, Status Updates, Metrics, and Dashboards)
• Focus on building robust development plans, competency models, internal growth, promotion, and retention of talent.
• Build opportunities for efficiencies in how work can be done, through a continuous improvement demeanor.
• Collaborate and partner with cross teams in quality, regulatory, and product development to help shape policies and work instructions to drive new innovative ways of working.

Skills: Operational Leadership, Regulatory Compliance, Laboratory Logistics, Digital Transformation, Team Supervision, Equipment Management, Cross-Functional Collaboration, Continuous Improvement

• Possess a broad and current understanding of the technical, equipment, and materials needs of the GTP research facilities.
• Ensure that all scientific equipment at the site remains accessible and in operable condition, including managing and scheduling installations, repairs, calibrations, certifications, validations, and decontaminations.
• Develop relationships with service contractors and equipment technicians to efficiently coordinate repairs and preventative maintenance of equipment.
• Co-manage the equipment database, confirming all equipment is entered, and all records are up to date regarding maintenance scheduling and records.
• Work with manufacturing and GMP groups to make sure all equipment is serviced, and equipment SOPs are current.
• Manage service contract timelines for applicable equipment.
• Oversee the resolution of any facility issues and coordinate lab build-out needs.
• Provide supervision for Lab Operations personnel
• Provide on-call emergency response for equipment on a rotational basis.

Skills: Equipment Management, Facility Oversight, Contractor Coordination, Database Administration, SOP Compliance, Lab Supervision, Maintenance Scheduling, Emergency Response

• Experience in a hospital laboratory with a supervisory/managerial position.
• National certification in laboratory management.
• Possess basic skills/knowledge in areas of operations management, change management, human relations, including team building and leadership skills, financial management/health economics, informatics, operating requirements, marketing, strategic planning, statistical analysis, ethics/bioethics, systems thinking, communication, quality management, and technology management.
• Effectively plan and organize work to meet established deadlines.
• Exercise independent judgment within the boundaries of knowledge and skills.
• Ability to analytically and independently act on the decision within the boundaries of knowledge and skills.
• Ability to accurately and completely document according to policy and procedure.
• Possess advanced computer skills, including Word, Excel, Access, and Outlook programs.
• Ability to teach/train others with successful outcomes.
• Ability to interpret results as to accuracy, acceptability, and critical limits.
• Ability to interact and provide care appropriate to the population of the patients served.

Qualifications: BS in Biochemistry with 8 years of experience

• Experience in Assisted Reproductive Technologies with excellence in vitrification and micromanipulation
• Supervisory experience and experience in training laboratory staff
• Experience managing all aspects of an IVF laboratory, and knowledge of accreditation/inspection processes
• Experience in establishing new laboratory facilities and processes
• Proactive and creative problem solver who is solution-oriented, a consensus builder, and who works to help team members
• Strong organizational and time-management skills
• Ability to lead and contribute to a positive work environment for all staff.
• Ability to perform and audit quarterly budgets
• Ability to maintain an effective inventory system
• Ability to participate in required managerial and provider meetings
• Ability to participate in patient education

Qualifications: BS in Microbiology with 13 years of experience

• Excellent executive presence, including strong communication skills and demonstrated ability to motivate and inspire others to action.
• Ability to forge a successful interaction with the key constituents that include customers and governments and business partners, and peers.
• Ability to record the development of industrial relationships for advanced technological deployment and development.
• Working knowledge of industrial and commercial practices in partnering and advanced research.
• Demonstrated ability for achieving excellence in operations, including security, safety, information systems management, financial operations, facility management, and environmental management.
• Skilled in implementing and communicating strategic direction and organizational vision.
• Ability to gain staff confidence and trust.
• Experience in laboratory management.
• Experience in growing and expanding a laboratory
• Must have strong interpersonal skills and be able to effectively communicate in English

Qualifications: BS in Pharmaceutical Sciences with 15 years of experience

• American Board of Medical Microbiology (ABMM), American Board of Medical Genetics and Genomics (ABMGG), and American Board of Bioanalysis (ABB) certification
• Experience directing a clinical laboratory with experience in High-complexity Laboratory Testing.
• Experience in complex molecular diagnostic techniques, including hands-on experience with Next-Generation Sequencing assays and review of metagenomic data analysis.
• Experience with developing a Quality Management Program for Clinical NGS testing.
• Must work effectively with an interdisciplinary team of scientists, physicians, and lab technologists.
• Excellent written and verbal communication skills
• Excellent capacity to collaborate and coordinate across multiple teams
• Demonstrated ability to manage teams
• Ability to rapidly detect operational roadblocks and propose solutions
• Strong organizational skills and attention to detail
• Fast thinker and ability to act promptly to solve issues that mitigate risk

Qualifications: BA in Chemistry with 12 years of experience

• Excellent written and oral communication skills.
• Experience leading a laboratory offering prenatal screening and oncology testing, and evaluating, interpreting, and reporting out NGS and microarray data.
• Familiarity with next-generation sequencing, and/or knowledge of advanced methods of copy number detection.
• Strong background in human and medical genetics, and oncology, with a familiarity with online human genomics.
• Understanding of statistical measures utilized in genetic testing and screening
• Board certification or experience in Molecular Pathology
• Strong communication skills, both verbal and written documentation
• Ability to communicate with high-level decision makers in the organization
• Personal adaptability and ability to lead change
• Ability to work across skill sets and expertise
• Excellent communication and interpersonal skills

Qualifications: BS in Biomedical Engineering with 9 years of experience