Molecular technologist job description

Would you like your professional energies and talents to contribute to a company that is ending cancer in pets and introducing precision, genomics-based medicine to veterinary care? Then this might be the place for you. Become part of a strong, science-based, fun-loving team that believes passionately in our mission, in each other, and in the power of the human-animal bond.

The Molecular Technologist II for Vidium Animal Health is an experienced professional who is passionate about improving the lives of pets. As the animal health arm of the Translational Genomics Research Institute, an affiliate of City of Hope, Vidium Animal Health is the leading genomic diagnostic company for companion animals in the world. Vidium's mission is to guide veterinarians and families through the difficult journey following a pet cancer diagnosis by providing them with the most cutting-edge information possible. Leveraging our state-of-the-art genomic diagnostics platform, we offer veterinarians new and transformative tools to tackle the most common diseases of companion animals - starting with cancer in dogs - and formulate better health solutions for pets and the families that love them. The Molecular Technologist will work as a part of a dynamic team in a fast-paced, startup environment toward creating a leading company in the field of veterinary diagnostics and comparative oncology.

Thanks to the rapidly evolving fields of genomics, transcriptomics and proteomics, the way we think about, diagnose and treat cancer in humans and pets is changing at an extraordinary pace. Vidium Animal Health is at the forefront of this revolution in veterinary medicine. Vidium has been built on unimpeachable science by a knowledgeable and experienced team with deep veterinary and clinical genomic. Learn more at Vidiumah.com/about-us.

The Molecular Technologist II performs complex technical work involving handling and testing of canine patient specimens. The position is responsible for performing extensive steps requiring pipetting, evaluation of data at QC checkpoints, and various molecular techniques that include but are not limited to, formalin-fixed paraffin-embedded tissue macrodissection, RNA/DNA extractions, PCR, Next Generation Sequencing, solution and reagent preparation, equipment maintenance, laboratory inventory, sample tracking, ordering supplies and receiving packages. This position works under limited supervision of the Senior Laboratory personnel and in adherence to established standard operating procedures (SOPs).

Evaluate specimens received by the clinical laboratory and organize workflow to provide optimum efficiency of testing and turnaround time (TAT) of results.

Sample preparation, including formalin-fixed paraffin-embedded tissue macro-dissection, snap or fresh-frozen tissue and fine needle aspirates.

Perform DNA and/or RNA extractions from assorted specimen types (FFPE Tissue, Fine Needle Aspirates and Fresh/Snap Frozen Tissues and Bone Marrow Aspirates) for molecular testing and ensure correct patient labeling.

Perform molecular techniques such as PCR, Next Generation sequencing methods and target enrichment (hybridization).

Document and assist in investigations for nonconformance events observed during the pre-analytical, analytical, and post-analytical clinical laboratory testing.

Perform and document proficiency testing in a timely manner and submit results to the Senior Lab personnel and Chief Scientific Officer.
Assist in conducting validation testing for new clinical assays when appropriate.
Perform quality control, validation, and other quality activities to verify performance of clinical assays.
Utilize the Laboratory Information Management System (LIMS) to enter and upload patient files, track, monitor and execute sample processing.
Train new molecular technologists upon hire.
Assist in troubleshooting instruments during times of failure.
Maintain laboratory equipment by performing assigned maintenance activities.
Prepare monthly reagent QC schedules and the appropriate paperwork for reagent QCs.
Evaluate inventory of supplies and reagents, communicate order needs, place orders and verify receipts. Inventory and manage stock as received.
Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives.
Participate in additional continuous quality improvement activities.
Document executed process steps per Good Documentation Practices (GDP). Update and maintain records and data on test results per GDP.
This position may require some evenings, weekends and/or Holidays.
Complete all required training and follow safety protocols at all times.
Each individual performs only those clinical tests that are authorized by the Laboratory Manager and require a degree of skill commen surate with the individual's education, training or experience, and technical abilities.
Each individual performing clinical testing must:
Follow the laboratory's proce dures for specimen handling and proc essing, test analyses, reporting and maintaining records of patient test results;
Maintain records that dem onstrate that proficiency testing sam ples are tested in the same manner as patient specimens;
Adhere to the laboratory's quality control policies, document all quality control activities, instrument and pro cedural calibrations and maintenance performed;
Follow the laboratory's estab lished policies and procedures when ever test systems are not within the laboratory's established acceptable lev els of performance;
Be capable of identifying problems that may adversely affect test perform ance or reporting of test results and ei ther must correct the problems or im mediately notify the Laboratory Manager;
Document all corrective actions taken when test systems deviate from the laboratory's established perform ance specifications; and
Perform clinical testing onsite, under the supervision of Laboratory Manager. pm21
Requirements:
Education and Experience
Bachelors or Master's degree in a science field (chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution) or;
o Associate degree in a laboratory science, or medical lab oratory technology from an accredited institution and 1 year of pertinent full-time lab oratory experience or training or;
o MT (ASCP) or MB (ASCP) preferred but not required.
1+ years of clinical reference laboratory work with molecular techniques.
Working experience in a high volume lab using established laboratory procedures. Ability to multi-task and work in a fast-paced, deadline driven environment.
Strong organizational skills and meticulous attention to detail is essential for success in this position.
Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.
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About the Job

The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. The incumbent works one of three established shifts and may be assigned to work any day that the lab is operational.

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

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

Key Responsibilities

* Prepare the Next Generation Sequencing (NGS) library.
* Under limited supervision of senior lab personnel and in adherence to established Standard Operating Procedures (SOPs):
* Extract and isolate nucleic acids.
* Complete hybridization capture, and genetic sequencing methods.
* Operate automated 8-span and 96-head liquid handling platforms.
* Operate quantification, sizing, and NGS instruments.
* Perform any other patient and client sample testing and processing steps needed.

* Perform workflow that maintains quality, thoroughness, and optimum efficiency for Turn Around Time (TAT).
* Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing.
* Document executed process steps per Good Documentation Practices (GDP).
* Update and maintain records and data on test results per GDP.
* Perform daily, weekly, monthly and as needed equipment maintenance checks.
* Participate in additional continuous quality improvement activities.
* Adhere to safety protocols, such as wearing laboratory coats and required safety gear.
* Maintain organization and cleanliness in the labs.
* Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes.
* Review SOPs at set intervals and sign-off to document knowledge of these procedures.
* Document and assist with investigations for non-compliance events via Non-Conformance Reports (NCRs), Corrective Action/Preventative Action (CAPAs) and other reports.
* Other duties as assigned.

Qualifications

Basic Qualifications

* Bachelor's Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory requirements)
* 1+ years of molecular laboratory work experience in a CAP/CLIA regulated lab
* Certifications or licensure that is required by the state or county in which the job is posted

Preferred Qualifications

* Molecular Biology American Society of Clinical Pathology (MB-ASCP) Certification
* Quality System Regulations (QSR) compliant laboratory experience
* Familiarity of and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry
* Familiarity with high throughput platforms and common molecular laboratory equipment (such as pipettes, thermocyclers, and liquid handlers)
* Experience with Laboratory Information Management System (LIMS)
* Experience ensuring and maintaining integrity and quality of the laboratory in the areas of sample processing, equipment maintenance, and SOPs
* Knowledge about laboratory safety protocols
* Demonstrated ability to:
* Work well under pressure while maintaining a professional demeanor both as an individual contributor and in a team
* Prioritize and thoroughly follow up on assigned tasks
* Handle multiple tasks at once and work in a fast-paced environment
* Adapt to changing procedures, policies and work environment
* Work in the presence of chemicals and reagents in a laboratory environment

* Proficiency utilizing Microsoft Office Suite, most specifically Excel and Power Point
* Excellent skills of written communication, oral communication, collaboration, and problem solving with other departments and colleagues
* Excellent organization and attention to detail
* Understanding of HIPAA and importance of patient data privacy
* Commitment to reflect FMI's Values: Patients, Passion, Collaboration, and Innovation

#LI-Onsite

For nearly 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

Process customer samples in the microbiology laboratory utilizing the various technology platforms including but not limited to bacterial 16S rDNA and fungal ITS2 sequencing, MALDI-TOF mass spectrometry and ribotyping. Ensure adherence to regulatory requirements and GMP compliance.
We are seeking aMolecular Technologist for our Microbial Solutionssite located Newark, DE.

The following are responsibilities related to the Molecular Technologist:

• Conduct accurate processing of customer samples in accordance with current SOPs.

• Receive, unpack, log, and subculture customer samples according to current SOPs.

• Aliquot and prepare reagents.

• Perform test streaks for isolation, PCR, sequencing of customer samples and other laboratory processes including but not limited to mass spectrometry and ribotyping.

• Perform continual maintenance, repair and cleaning of all laboratory equipment.

• Perform pipette verification.

• Operate and maintain laser cutter.

• Provide backup for all laboratory functions when needed.

• Dispose of microbe cultures, chemicals and glass in proper waste containers.

• Collaborate with technical support to resolve discrepancies with customer samples.

• Comply with all aspects of laboratory safety, safety stations, safety manuals, safety SOP, and MSDS sheets.

• Suggest process improvements.

• Perform or support special projects in the lab when needed.

• Perform all other related duties as assigned.

The following are minimum qualifications related to the Molecular Technologist position:

• Education: Bachelor's Degree (B.A. /B.S.) in Microbiology or related discipline required.

• Experience: 0-3 years related experience in a laboratory setting.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Certification/Licensure: None.

• Other: Must have working knowledge of the Quality System and Laboratory Information System. Must have ability to work in a fast paced and team oriented work environment. Strong attention to detail and accuracy required.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet