Lab Operations Manager
T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR, the Company’s proprietary magnetic biosensor detector. The T2MR technology enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate, and rapid diagnostic results. The company’s products can detect molecular or immunoassay targets and provide a robust menu of hemostasis measurements directly from unpurified clinical samples in hospitals, labs and physicians’ offices. We are seeking a talented and highly motivated Lab Operations Manager to join our Diagnostics R&D group. If you have experience in the in vitro diagnostics industry, this could be a very exciting position for you.
You will manage laboratory operations in support of company goals including the direction and planning of analytical, biological and microbiological workflows to minimize or eliminate sources of laboratory contamination. You will manage laboratory operations to assure compliance with Good Laboratory Practices, OSHA and local, state and federal environmental regulations.
Duties and Responsibilities:
- Develop, implement, monitor and enforce laboratory contamination control policies and procedures to minimize/prevent microbial and amplicon contamination of the laboratory environment.
- Manage lab equipment program, including but not limited to installation, training, repair, qualification, calibration, and maintenance of general & specialized laboratory equipment.
- Manage ordering, receiving, and inventory of lab-related materials and consumables.
- Manage and implement chemical/reagent formulation, identification, handling and storage activities.
- Assure that laboratory staff adheres to good documentation practices and effective lab notebook maintenance practices.
- Work with Facility Manager to assure that laboratory waste handling practices conform to internal procedures and regulatory requirements
- Create and implement policies and infrastructure to support multiple projects ranging from concept/research through product development
- Work with Facility Manager to assure that laboratory staff adheres to applicable lab safety procedures and OSHA standards.
- Coordinate and report on environmental monitoring of controlled environment areas.
- Plan laboratory work flow and coordinate execution of experiments to assure that activities are conducted in accordance with defined protocols and procedures.
- Interface with external vendors and service companies as well as internal management, purchasing, IT, and quality groups
- Accountable for lab inspections, audits, and training
This position requires strong communication skills, demonstrated leadership and self-motivation. You must possess the ability to motivate and guide colleagues, subordinates and external contractors to meet operational requirements.
- Degree in microbiology or molecular biology or related field required.
- 3+ years of direct technical experience; IVD industry experience preferred;
- 3+ years lab management experience working in an industry setting;
- Experience in Microbiology, equipment calibration, clean room management and PCR lab practices;
- In depth knowledge of lab safety requirements and Good Laboratory Practices
- Knowledge of aseptic techniques, universal precautions for blood handling, and practices to assure proper handling of microbial isolates and cultures and PCR samples
- Experience managing equipment programs, including equipment maintenance, calibration, and qualification;
- QC lab experience and quality systems experience a plus;
- Excellent organizational, record keeping and communication skills;
- Track record for efficiency, attention to detail, and proactively taking responsibility for executing tasks in a laboratory setting; and
- Motivation to maintain laboratory operations in a continuous state of compliance with regulatory requirements and T2 Biosystems policies/procedures.
Working Conditions: Molecular biology, microbiology, engineering laboratory and clean room environments. There is potential for exposure to chemicals, blood borne pathogens and other potentially infectious materials.
To apply, please send your résumé and cover letter to firstname.lastname@example.org , and write the job title in the subject line. T2 Biosystems, 101 Hartwell Ave. Lexington, Ma 02421
T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.