Clinical Laboratory Process Development Associate I

Clinical Laboratory Process Development Associate (PDA)

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 worlds 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 in 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 to meet 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 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 designing and executing 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 work of other laboratory personnel such as Process Development Technicians and Accessioning Technicians as required.

Primary Responsibilities:

• Follow standard operating procedures

• Each individual performs only those high complexity tests that are authorized by the Laboratory Director and require a degree of skill commensurate with the individuals education training experience and technical abilities.

• Tests will require the exercise of independent judgment and responsibility with minimal supervisor by the laboratory director or supervisor

• Adhere to the laboratorys quality control policies document all quality control activities instrument and procedural calibrations and maintenance performed.

• Follow the laboratorys established policies and procedures whenever test systems are not within the laboratorys 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 laboratorys established performance specifications.

• Review and monitor quality metrics and communicate results to others in the Platform during dedicated meetings as needed.

Minimum Qualifications:

• 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 B.S./B.A. degree

• Working solid knowledge of primary biological science principles required.

• Recent (within the last year) laboratory experience with the use of standard lab equipment such as pipettes and centrifuges required

• Strong analytical skills problem solving ability and innovation aptitude required.

• Working knowledge of computers databases and working in a Windows/Mac environment required.

Required Skills and Attributes:

• Must have strong attention to detail the ability to multi-task and strong organizational skills.

• Must follow Standard Operating Procedures and policies.

• Excellent written and oral communication skills interpersonal skills and ability to effectively work as part of a team required.

• Ability to work independently with minimal supervision.

• Must thrive in a fast-paced environment.

Preferred Experience:

• Experience with RNA and/or DNA extraction and library construction

• Experience with genomic sequencing

• Experience with laboratory automation

• Data accessioning experience