Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Manager, Laboratory Operations, Reagent QC

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Manager, Laboratory Operations, Reagent Quality Control (QC) is a position within Laboratory
Operations overseeing and heavily involved with maintaining and developing a high performing
functional reagent QC system within FMI’s clinical laboratories. The position leverages a high level of
experience in equipment maintenance, solution and reagent preparation and other tasks in a highly
complex clinical diagnostic laboratory.


This is a regulated position and additional information may be available from FMI Quality Assurance
regarding regulatory guidelines.


Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities 

• Partner with laboratory operations leadership on building, developing, and maintaining a high
performing functional reagent QC system for FMI’s CLIA & QSR laboratories.
• Collaborate cross-functionally on reagent QC as needed, including but not limited to with Quality
Assurance, Product & QSR Development, Process Engineering and Technology, Corporate
Management and Strategy, and Materials Management.
• Lead initiatives on quality and continuous improvement of reagent processing.
• Maintain availability to the team as a “go-to” person to field questions.
• Support training and site-site Tech Transfer of the Reagent QC process in addition to
troubleshooting efforts.
• Support the review of data and assembly of batch records for QC release of materials from
Quarantine to clinical laboratories.
• Support inspection of materials utilized in clinical and companion diagnostic assays.
• Support the supervisor with organizing, scheduling and performing reagent QC testing.
• Support new technology development projects that impact operational performance.
• Support collecting, maintaining, and evaluating monthly metrics and inventory.
• Deliver results according to established timeframes.
• Train others in qualified laboratory functions and tasks.
• Assist with storage and upkeep of paper-based and electronic, documents, records, reports, and
logs, i.e. General x Practices (GxP) records, related to reagent QC.
• Assist with preparation and aliquoting of solutions and reagents routinely used across all assays.
• Perform daily, weekly, monthly and as needed equipment maintenance checks.
• Facilitate the maintenance of the lab including routine housekeeping, lab inventory, and equipment.
• Be proficient in routine Laboratory Standard Operating Procedures (SOPs).
• Prepare documentation and QC kit assembly prior to QC testing.
• Comply with Current Good Manufacturing Practices (cGMP) in performing highly complex Reagent
QC testing according to established Standard Operating Procedures (SOPs), extractions, Next
Generation Sequencing (NGS) library prep, hybridization, and sequencing.
• Operate automated 8-span and 96-head liquid handling platforms for quality control sample
processing.
• Operate quantification (ssDNA and dsDNA), sizing, and NGS instruments.
• Participate in reagent and assay quality control, validations and stability studies as needed.
• Contribute to, review, edit and write SOPs, tacking forms, training logs and any required Quality
Management System documentation as needed.
• Provide support for Installation Qualification, Operational Qualification and Performance
Qualification for processes within the Laboratory Operations team.
• Complete documentation and analysis of test results.
• Provide advanced troubleshooting of assays and instrumentation.
• Support the Materials Team with inter- and intra-site inventory transfer of critical materials such as
baitsets and process controls.

• Maintain flexibility to cover scheduling gaps as needed and to be included in the on-call rotation for
additional weekend and/or holiday technical support as needed.
• Other duties as assigned.

Qualifications

Basic Qualifications
• Bachelor of Science in a biological or life science
• 7+ years of relevant lab experience in a Clinical Laboratory Improvement Amendments
(CLIA)/College of American Pathologists (CAP)/NYS accredited or certified lab\

Preferred Qualifications
• Experience interpreting and applying laboratory safety protocols
• Ability to clearly communicate complex technical information to internal and external stakeholders
in various formants including reports and presentations
• Experience with ensuring and maintaining integrity and quality of the lab (compliance with FMI’s
Quality Management System (QMS))
• Experience with a Laboratory Information Management Systems (LIMS)
• American Society for Clinical Pathology/ASCP certification in Molecular Biology
• Proficient with QC testing procedures
• Deep knowledge and experience working with DNA manipulation techniques, enzymatic reactions,
and sequencing chemistry
• Deep knowledge and experience with high through-put platforms and common molecular
laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.)
• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point
• Strong organizational skillset
• Excellent verbal and written communication skills
• Ability to deliver results on schedule in a fast -paced, dynamic environment
• Ability to work well under pressure while maintaining a professional demeanor
• Ability to prioritize and thoroughly follow up on assigned tasks
• Ability to adapt to changing procedures, policies and work environment
• Ability to work in a laboratory environment in the presence of chemicals and regents.
• Demonstrated integrity and a commitment to values held at FMI: patients, innovation,
collaboration, and passion
• Understanding of HIPAA and importance of privacy of patient data

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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