• Plans and conducts experiments at the bench related to one or more projects related to low-input and challenging nucleic acid library preparations for NGS.
• Works with under guidance from Product Managers and senior scientists to ensure projects are developed according to specifications and set deadlines.
• Learns about TBUSA’s market and competitors through interaction with Product Managers.
• Identifies potential new products for development based on assessment of customer demand, market trends, and competitor analysis with help from Product Manager and more senior researchers in the group.
• Develops and launches new products according to approved proposals and within stated deadlines.
• Serves as resource to R&D and other departments within the organization, including Product Management, Planning, QC, and Product Transfer in a particular field of specialization.
• May represent Research and Development at scientific meetings – typically by presenting posters.
• May to support Technical Support representatives on technical matters.

• Learns and adheres to quality system protocols.
• Conducts experiments of high quality, exhibiting good experimental design, data summary and interpretation, and clear report preparation.
• Exhibits good professional ethics.
• Contributes data/findings for use in reports, documents, or verbal/written presentations.
• Drafts SOPs, user manuals and other related technical documents, with assistance from more senior R&D members.
• Approximately 5% travel may be required.
• Additional duties as assigned.

• Fully responsible for proposing experimental plan/design, but may receive guidance from other scientists.
• Learning about manufacturing processes and requirements – SOPs, etc. and how to draft these.
• Limited experience with contractual matters such as CDAs, etc.

• Typically requires a Ph.D. in a relevant scientific discipline and some postdoctoral experience.
• Expert knowledge of scientific principles and concepts with specialized skills in a specific area, not simply knowledge of techniques (e.g.qPCR, DNA/RNA isolation and handling, FFPE nucleic acid isolation and handling, ctDNA/cfDNA isolation, oligo design, WGA, epigenetics, NGS library preparation and sequencing).
• Effective analytical, problem solving and judgment skills.
• Good interpersonal skills.
• Excellent oral and written communication skills.

Strata Oncology is looking to hire a dynamic and experienced Laboratory Manager to join our laboratory operations team. As a part of Strata, you will help us continue transforming cancer care by expanding patient access to precision medicine clinical trials and accelerating drug approval. Strata's national precision oncology platform serves the needs of patients, providers and drug developers by providing a link from patient screening to streamlined enrollment in variant-matched clinical trials.

As a leader of the clinical laboratory team, you will have a real-world impact every single day. Whether working to ensure the accuracy and efficiency of our high-throughput, clinical tests or helping to contextualize results for physicians and patients, your contributions will make a difference. We’ve raised $38 million from investors including Pfizer Ventures, Merck Global Health Innovation Fund, and Arboretum Ventures.

Job Description:

The Laboratory Manager coordinates day-to-day laboratory operations and ensures a high level of technical performance, from histology through next generation sequencing, with some involvement in supply chain management, including specimen management and accessioning. The lab manager will ensure established procedures and processes are followed and will work with the Director of Operations to ensure compliance. The Laboratory Manager will also maintain readiness for regulatory inspections, including CAP/CLIA, and internal audits.

Job Responsibilities:

• Coordinates daily scheduling for accessioning, histology, and molecular oncology departments
• Works closely with the Director of Operations to maintain accountability in all technical departments for testing completion, training & competency, staffing & overtime, and additional responsibilities
• Ensures CAP/CLIA regulatory compliance in conjunction with Director of Quality
• Maintains laboratory equipment including instrument performance qualification and coordination of equipment replacement, service, and repair.
• Lead maintenance of laboratory diagnostic equipment and other technical resources.
• Coordinate on-the-job training for Senior Technologists and Molecular Technologists on new procedures.
• Works closely with Lab Informatics team and Director of Operations to research and resolve complex issues, including collaborating on all necessary documentation.
• Responds positively to change and willingness to learn new ways to accomplish work.
• Works closely with Director of Operations and Lab Informatics team to identify information needs and issues and recommend process improvements
• Communicate effectively to enhance productivity, build respect, and seek constructive approaches to resolving workplace issues.
• Coordinates performance improvement activities and helps lead continuous quality improvement activities.
• Actively participates in continuing education opportunities.
• Troubleshoots operational problems and issues.
• Adheres to all safety and OSHA policies and procedures.
• Maintains a professional appearance and interacting effectively to build respectful relationships with coworkers, supervisor and other personnel.
• Follows Company policies and procedures at all times.
• This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.

Qualifications:

• Master’s or Bachelor of Science degree in Medical Laboratory Sciences, Medical Technology, Molecular Biology, related field, or equivalent or compliant with CLIA ’88 requirements for High Complexity testing personnel.
• >5 years clinical laboratory and/or research experience with ASCP, CLS, or equivalent certification, of which at least 1 year is in molecular pathology.
• >5 years managerial experience in a CAP/CLIA laboratory with strong knowledge of clinical laboratory regulatory requirements required.
• Managerial experience in molecular biology, including next generation sequencing, genomics, and/or genetics, strongly preferred.
• Knowledge of clinical oncology, including histology and/or molecular oncology, preferred.
• Must be able to handle multiple tasks and work in a fast-paced environment.
• Must be detail-oriented, organized, self-starter, and have the ability to prioritize workload.
• In accordance with HIPAA, this position must maintain the confidentiality of the patient in all circumstances as well as Company confidentiality. Ensures the confidentiality of all patient data is maintained.

Strata Oncology is an equal opportunity employer.