Clinical Laboratory Process Development Associate

Clinical Laboratory Process Development Associate I

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The Genomics Platform has delivered on transformative projects for more than 30 years. We create foundational genomics resources and capabilities for the community and undertake large-scale disease-based projects that pioneer approaches and advance the understanding of the genomic basis of disease and other traits. We are dedicated to solving the world’s most challenging biomedical problems through the continuous development and investment in cutting edge technology and large‑scale research projects that are both challenging and complex.

Data generated by the Genomics Platform has enabled a wide range of applications, from variant discovery to delivery of polygenic risk scores and clinical diagnoses, and contributed knowledge to a wide array of fields, from rare disease research to population genomics, from cancer clinical trials to understanding cell circuitry.

We are expanding our team to support constantly evolving initiatives at our new, state‑of‑the‑art facility located at 27 Blue Sky Drive, Burlington, MA.

The Clinical Laboratory Process Development Associate (PDA) will be committed to carrying out innovative, high‑throughput lab processes and supporting the highest quality research to realize the full promise of genomic medicine. Process Development Associates I (PDA I) are responsible for processing samples through a high‑throughput clinical diagnostics laboratory and meeting production goals. PDAs will function as the regulatory equivalent of clinical laboratory technical personnel (i.e. medical technologists).

PDAs will be trained to perform clinical laboratory tests under general supervision. In addition to standard production processes, this position will require individuals to participate in continuous improvement solutions through appropriate change‑management procedures and troubleshooting processes as needed.

The individual may be involved with the design and execution of development, process improvement, or troubleshooting projects under direct guidance from the supervisor in support of platform goals and may be required to complete related training in JMP, Six Sigma, or other process‑improvement methods. Upon completion of these projects the individual is responsible for documenting and communicating results to others in the Platform during dedicated meetings.

In addition, PDAs will assist with the general supervision of the work of other laboratory personnel such as Process Development Technicians and Accessioning Technicians as required.

• Follow standard operating procedures.
• Perform only those high‑complexity tests that are authorized by the Laboratory Director and require a degree of skill commensurate with the individual’s education, training, experience, and technical abilities.
• Exercise independent judgment and responsibility with minimal supervision by the laboratory director or supervisor.
• Adhere to the laboratory’s quality control policies and document all quality control activities, instrument and procedural calibrations, and maintenance performed.
• Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
• Be capable of identifying problems that may adversely affect test performance or reporting of test results, correct the problems according to procedures or immediately notify the General Supervisor, Technical Supervisor, Clinical Consultant or Laboratory Director.
• Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
• Review and monitor quality metrics and communicate results to others in the Platform during dedicated meetings as needed.

• BS/BA degree in Biology or Chemistry. Please be prepared to provide a copy of the diploma and transcripts upon request.
• 1+ years of relevant full‑time clinical laboratory experience in this specialty subsequent to obtaining a B.S./B.A. degree.
• Solid knowledge of…