Manager, Clinical Laboratory Operations

2 weeks ago

Waltham, United States BostonGene Full time

Job summary

The Manager of Clinical Laboratory Operations will be responsible for performing and overseeing high complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing.

Responsibilities

* Perform high-complexity molecular testing according to established SOPs, including DNA and


* RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing.


* Design and lead lab projects and provide project instruction to technologists


* Mentor and supervise direct reports


* Ensures verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.


* Facilitate proficiency testing through the wet lab


* Resolve technical problems and ensure that remedial actions are taken when deviations occur.


* Ensure procedures are reviewed and approved and are followed by all personnel responsible for any aspect of the testing process.


* Evaluate the competency of testing personnel and ensure that the staff maintains competency to perform test procedures and report results promptly, accurately, and proficiently.


* Review quality control documents monthly.


* Review quality assurance and quality control records as needed and serve as a technical resource for the department by investigating and resolving analytical testing problems and recommending a course of action in instances identified as beyond acceptable limits.


* Oversee ordering and maintaining adequate supplies of all reagents and consumables.


* Oversee reagent and assay quality control and validations.


* 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 and maintain records and data for executed process steps per Good Documentation Practices (GDP).


* Adhere to safety protocols, such as wearing laboratory coats and required safety gear.


* Maintain organization and cleanliness in the labs.


* Collaborate on SOP revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes.


* Support planning and execution of process development and improvement activities, including LIMS and automation projects.


* Develop a close working relationship with the other technical and scientific staff while collaborating effectively with colleagues from other sections.



Qualifications

* Minimum Bachelor of Science (BS) in Biological or Life Sciences.


* Ability to learn new tasks in appropriate timeframes.


* Excellent attention to detail with experience following precise instructions.


* Well-organized.


* Excellent communication skills.


* Proficiency in Laboratory Information Management System (LIMS).


* Working knowledge in an NGS (Next-Generation Sequencing) environment.


* Knowledge of laboratory safety protocols.


* Experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, SOPs).


* Minimum 8+ years of relevant lab experience in a CLIA/CAP lab.



Copy link

Copied

  • Manager, Clinical Laboratory Operations

    2 weeks ago

    Waltham, United States BostonGene Full time

    Job summary The Manager of Clinical Laboratory Operations will be responsible for performing and overseeing high complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing. Responsibilities * Perform high-complexity molecular testing...

  • Laboratory Technologist 2

    3 weeks ago

    Waltham, United States Sustainable Talent Limited Liability Company Full time

    Job DescriptionJob DescriptionSustainable Talent is teaming up with a global leader in clinical diagnostics, environmental, food, pharmaceuticals and cosmetics testing services, to grow their team. My client offers competitive compensation, full health benefits, and matched 401k.This position is based in Waltham, MA and is a Direct Hire Laboratory...

  • Laboratory Technician, Biospecimen Services

    3 weeks ago

    Waltham, United States BostonGene Full time

    Position OverviewThis role is pivotal in providing operational support to the BostonGene laboratory by managing biospecimen inventory, reagent control, and instrument quality control (QC) in alignment with CAP/CLIA and GCLP standards. The position involves maintaining accurate documentation and ensuring compliance with laboratory protocols and procedures.Key...

  • Laboratory Technician, Biospecimen Services

    3 weeks ago

    Waltham, United States BostonGene Full time

    Position OverviewThis role is pivotal in providing operational support to the BostonGene laboratory by managing biospecimen inventory, reagent control, and instrument quality control (QC) in alignment with CAP/CLIA and GCLP standards. The position involves maintaining accurate documentation and ensuring compliance with laboratory protocols and procedures.Key...

  • Laboratory Technician, Biospecimen Services

    3 weeks ago

    Waltham, United States BostonGene Full time

    Position OverviewThis role is pivotal in providing operational support to the BostonGene laboratory by managing biospecimen inventory, reagent control, and instrument quality control (QC) in alignment with CAP/CLIA and GCLP standards. The position involves maintaining accurate documentation and ensuring compliance with laboratory protocols and procedures.Key...

  • Laboratory Supervisor- 1st shift

    1 month ago

    Waltham, United States Sustainable Talent Limited Liability Company Full time

    Job DescriptionJob DescriptionSustainable Talent is teaming up with a global leader in the clinical diagnostics, environmental, food, pharmaceuticals and cosmetics testing as well as in agro-sciences CRO (Contract Research Organization) services to grow their team. This position is based in Waltham, MA and is a 1st shift position Monday - Friday. Pay is...

  • Senior Clinical Trials Manager

    2 weeks ago

    Waltham, United States Clinical Dynamix, Inc. Full time

    Global Publicly Traded Pharmaceutical company is expanding.The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs....

  • Laboratory Technologist

    3 weeks ago

    Waltham, United States Sustainable Talent Full time

    Job DescriptionJob DescriptionSalary: $23+ per hour based on experienceSustainable Talent is teaming up with a global leader in the clinical diagnostics, environmental, food, pharmaceuticals and cosmetics testing as well as in agro-sciences CRO (Contract Research Organization) services to grow their team. This position is based in Waltham, MA and is a Direct...

  • Laboratory Technologist 1- 3rd shift.

    1 month ago

    Waltham, United States Sustainable Talent Limited Liability Company Full time

    Job DescriptionJob DescriptionSustainable Talent is teaming up with a global leader in the clinical diagnostics, environmental, food, pharmaceuticals and cosmetics testing as well as in agro-sciences CRO (Contract Research Organization) services to grow their team. We are looking for a Direct Hire Laboratory Technologist to support our client based in...

  • Clinical Quality Manager

    4 weeks ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance...

  • Clinical Quality Manager

    1 month ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance...

  • Clinical Quality Manager

    4 weeks ago

    Waltham, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance...

  • Associate Director, Laboratory Information

    1 month ago

    Waltham, United States AstraZeneca Full time

    **Associate Director, Laboratory Information Management System (LIMS) Product Owner** **Gaithersburg, MD or Waltham, MA** Join our Translational Medicine and Cancer Biomarker Development (TM/CBD) teams within Early Oncology at AstraZeneca, where we strive to transform oncology patient care through the development of mechanistically-based and clinically...

  • Manager, QA Operations

    6 days ago

    Waltham, United States TScan Therapeutics Full time

    **Position Summary**: TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. This position will be...

  • Director, Clinical Operations

    6 days ago

    Waltham, United States Ophthalmic Consultants of Boston Full time

    Job DescriptionJob DescriptionOphthalmic Consultants of Boston (OCB) is recruiting for a Director, Clinical Operations.  This multifaceted opportunity is 100% onsite.Summary of Responsibilities:The Director, Clinical Operations (Director) has overall responsibility for clinical management of all OCB practice locations.  This includes development and...

  • Director, Clinical Operations

    4 weeks ago

    Waltham, United States Ophthalmic Consultants of Boston Full time

    Job DescriptionJob DescriptionOphthalmic Consultants of Boston (OCB) is recruiting for a Director, Clinical Operations.  This multifaceted opportunity is 100% onsite.Summary of Responsibilities:The Director, Clinical Operations (Director) has overall responsibility for clinical management of all OCB practice locations.  This includes development and...

  • Manager, QA Operations

    3 days ago

    Waltham, United States TScan Therapeutics Full time

    Position Summary:TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. This position will be based...

  • Manager, QA Operations

    4 days ago

    Waltham, United States TScan Therapeutics Full time

    Job DescriptionJob DescriptionPosition Summary:TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy...

  • Manager, QA Operations

    7 hours ago

    Waltham, United States TScan Therapeutics Full time

    Position Summary: TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. This position will be...

  • Senior Manager, Clinical Operations

    3 weeks ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description The Senior Manager Clinical Operations will provide line management to Clinical Trial Coordinators (CTCs), Clinical Trial Associates (CTAs) and Senior CTAs and will develop robust and flexible methodologies to optimize and harmonize the administrative and operational support provided to the clinical trial teams.  What You’ll...