Laboratory Supervisor, CMCF

				Overview:

The Laboratory Supervisor (SCT, NCT and MOS) functions as the managing technologist, under the guidance of the Lab Manager and is responsible for day-to-day supervision or oversight of the laboratory operation and staff performing manufacturing. Must fulfill the responsibilities of a Technical Supervisor under 42 CFR 493.1463. Responsible for day-to-day supervision or oversight of the laboratory operation and staff performing testing and reporting test results. Wider scope within the Cell Therapy lab, the areas include immunology. microbiology, hematology & molecular.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities:

* Perform the duties of a Lead Specialist approximately 95% of the time.
* Staff Supervision: Overseeing and coordinating the work of laboratory staff. Providing training and guidance to team members in cell processing activities. Contributes with Managers on performance evaluations.
* Cell Culture Management: Overseeing the cultivation and maintenance of cell cultures. Ensuring adherence to sterile techniques and proper cell handling procedures. Responsible for the validation of genetically engineered and regenerative medicine products
* Quality Assurance: Implementing and enforcing quality control measures to ensure the accuracy and reliability of cell manipulation processes, including regular inspections and assessments. Addressing and resolving issues related to data integrity and experimental quality. Responsible for writing and executing the validation of new processes. 
* Protocol Implementation: Contribute to the development and optimization of cell processing protocols, ensuring efficiency, scalability, and adherence to regulatory standards. Is responsible to insure alignment between Sponsor and CMCF documentation.
* Regulatory Compliance: Stay current with industry regulations and standards related to cell processing and ensure that the laboratory operates in accordance with these regulations. Participates in site audits and inspections. Gathers and reviews required documents for audits.
* Documentation and Record Keeping: Maintain accurate, concurrent, and detailed documentation of cell therapy processes. Maintaining comprehensive records for compliance and traceability. Accurately enter and maintain records of procedures and enter data, both manually and on electronic data capture systems. Write and review Standard Operating Procedures ensuring compliance with clinical trial protocols.
* Training and Development: Provide training to laboratory staff on cell processing techniques, safety procedures, and relevant technologies. Support ongoing professional development.
* Collaboration: Collaborating with researchers, scientists, clinicians, and other stakeholders involved in cell therapy projects to understand project requirements and ensure that cell processing activities align with project goals. Facilitating communication and cooperation within the laboratory team. Develop validation and qualification plans as needed. 
* Continuous Improvement: Identifying opportunities to improve efficiency in cell therapy processes. Implementing strategies to enhance productivity and reduce risks. Actively involved in the implementation of the improvement.
* Safety Compliance: Enforcing and promoting a culture of safety within the laboratory, including the use of personal protective equipment and adherence to biohazard containment protocols.
* Inventory Management: Manage and monitor inventory of trial specific vectors required for cell therapy activities. Ensure that Materials Management staff are aware of upcoming processing so that all supplies are available. Research new and alternate materials to improve ongoing processes and implement new processes. 
* Product Inventory Management: Responsible for overseeing the tracing of products, storage locations, and disposition of products in accordance with SOPs. Coordination with trial sponsors on the disposition and transfer of remaining products.
* Project Management: Coordinate cell therapy activities within the laboratory in alignment with project timelines, objectives, and milestones. Coordination with clinicians to ensure timely delivery of product to patient. Assign project leads for trials and work closely with the leads to assure project data is valid, and processes updated.
* Troubleshooting: Addressing and resolving technical issues or deviations from protocols, implementing corrective actions as needed. 
* Oversees environmental monitoring of work area and laboratory.
* Lead, supervise and perform validation studies, including design, developing validation protocol, and collaborating with sponsors on IND submissions.
* Works closely with Manager and Technical Director in the day-to-day operation and management of the laboratory, including scheduling procedures, document review, and supervision of activities. 
* Participates in organization/ professional activities such as committees, workgroups, etc.

SUPERVISORY RESPONSIBILITIES:

* No direct reports; 8 indirect reports

Qualifications:

* Bachelor's degree in a Biological Science, Medical Technology or equivalent.
* Minimum of 5 years in cellular therapy in minimally manipulated cellular therapy products. 
* 3 years of demonstrated leadership experience.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: 

* Proficiency in cell therapy testing procedures including immunology, microbiology, hematology, molecular, instrumentation, and data analysis tools is essential.
* Demonstrates knowledge of highly complex assays across multiple laboratory disciplines (immunology, microbiology, hematology, molecular). Reviews quality control and instrument calibration and maintenance basis as required by standards. Investigates areas on non-compliance and takes appropriate corrective action.
* Demonstrates competency and is a subject matter expert in the following areas: 
* immunology
* microbiology
* hematology
* molecular

* Demonstrates competency to perform final review of test results prior to sending to processing labs. Assess deltas from previous values. Investigates and takes appropriate action when values are not trending appropriate.
* Possesses the ability to recognize additional qualifications and requirements for non-licensed reagents and test methods for clinical assays defined as laboratory defined tests and meets the regulatory requirements. Performs final sign off on qualification.
* Demonstrates the ability to identify, evaluate, and troubleshoot or correct problems related to product preparation, including issues with instrumentation, reagents, and documentation. Appropriately communicate outcomes, including escalating problems to leadership.
* Knowledge of safety protocols and regulations relevant to the laboratory's field of work.
* Strong communication and interpersonal skills to effectively collaborate with team members and researchers.
* Excellent organizational abilities to manage resources, schedules, and data effectively.
* The ability to identify and solve issues that may arise during clinical manufacturing or operations and work with QA to identify CAPA and implement changes as needed.
* Leadership skills to motivate and manage.
* Flexibility to adapt to changing research needs and technologies.
* Strong attention to detail. A keen eye for data integr
			

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Dana-Farber Cancer Institute