Associate Director, QC Analytics, Cell Therapy

3 weeks ago

Watertown, United States ElevateBio Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

The Associate Director of Quality Control is responsible for overseeing the QC Cellular Therapy analytical laboratory, testing, and staff at our BaseCamp facility in Waltham. This position will work with Quality management and Analytical Development to implement the laboratory systems and testing strategies for ElevateBio's cell and gene therapy programs. Additionally, the Associate Director will monitor laboratory metrics and review and approve excursions associated with routine laboratory operations.

Here's What You'll Do:

  • Develop, implement, and maintain laboratory systems in compliance with applicable GMP practices and regulations.
  • Draft, review, and approve SOPs, test methods, specifications, and associated protocols and reports.
  • Co-Qualify/Validate or Transfer test methods with Analytical Development Tech Transfer team.
  • Oversee daily laboratory operations, including equipment maintenance and calibration, routine analytical testing, and results reporting in LIMS.
  • Collaborate with other QC functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing/Logistics) to ensure all testing is initiated and completed within established timelines.
  • Review and approve analytical testing excursions, including deviations, CAPAs, and OOSs.
  • Develop metrics to evaluate and monitor the performance of the QC cellular analytics laboratory.
  • Support inspections and facility audits.
  • Hire, train, and mentor laboratory staff.
Requirements:
  • B.S. or M.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 10 years of experience in GMP QC laboratory setting, preferably in a cell and gene therapy manufacturing environment.
  • Significant experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
  • Ability to communicate and work independently with scientific/technical personnel.
  • Strong knowledge of GMPs, SOPs, and Quality system processes.
  • Excellent organizational skills.
  • Experience performing laboratory investigations.
  • Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.


Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

  • Senior Director, Head of Product Sciences

    2 months ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is a biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases....

  • Senior Director, Head of Product Sciences

    2 weeks ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is a biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases....

  • Scientific Associate

    4 weeks ago

    Watertown, United States CSL Full time

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from...

  • Associate Director, Quality Systems

    2 months ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

  • Associate Director, Quality Systems

    1 month ago

    Watertown, United States Affini-T Full time

    About Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of...

  • Associate Director, Quality Systems

    2 weeks ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

  • Quality Control Analyst I/ii

    2 weeks ago

    Watertown, United States Mariana Oncology Full time

    **Reporting**: Associate Director, Quality Control **Description**: Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best-in-class alpha - and beta-emitting radioligands that target cancer, while mitigating destruction to healthy...

  • Senior Director, Head of CMC

    2 days ago

    Watertown, United States Seismic Therapeutic Inc Full time

    Job DescriptionJob DescriptionAbout Seismic TherapeuticSeismic, a biotechnology company, is determined to help patients by integrating machine learning, structural biology, protein engineering, and translational immunology to create optimized therapies for patients with autoimmune disease. At our core, we are focused on phenomenal science, supportive...

  • Senior Scientist, Product Sciences

    2 months ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

  • Senior Scientist, Product Sciences

    1 month ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

  • Senior Scientist, Product Sciences

    2 days ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

  • Senior Scientist, Product Sciences

    2 weeks ago

    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...

  • Process Development Engineer

    2 weeks ago

    Watertown, United States LASE Innovation Inc. Full time

    We are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Development Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...

  • Process Engineer

    2 weeks ago

    Watertown, United States LASE Innovation Inc. Full time

    We are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional single-cell...

  • Process Development Engineer

    2 weeks ago

    Watertown, United States LASE Innovation Inc. Full time

    We are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Development Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...

  • Senior Research Associate, Preclinical

    1 month ago

    Watertown, United States Corner Therapeutics Full time

    The Senior Research Associate will report to the Director of Immunology in the Preclinical Department. Within the Preclinical Department, the predominant focus will be to generate data in support of bringing our innovative therapies to the clinic. Specifically, scientific work will focus on the use of primary cells and cell lines in tissue culture to...

  • Senior Research Associate, Preclinical

    2 weeks ago

    Watertown, United States Corner Therapeutics Full time

    The Senior Research Associate will report to the Director of Immunology in the Preclinical Department. Within the Preclinical Department, the predominant focus will be to generate data in support of bringing our innovative therapies to the clinic. Specifically, scientific work will focus on the use of primary cells and cell lines in tissue culture to...

  • Cell Integration Engineer

    2 months ago

    Watertown, United States CareerBuilder Full time

    A123 Systems, LLC in Waltham, MA is hiring a Cell Integration Engineer . The Cell Integration Engine er will work as part of a development team to design and produce next-generation all solid state battery (ASSB) electrodes and cells. The candidate shall have experience with a variety of cell chemistries, including lithium iron phosphate (LFP) and...

  • Senior Research Associate, Preclinical

    2 months ago

    Watertown, United States Corner Therapeutics Full time

    Job DescriptionJob DescriptionSalary: The Senior Research Associate will report to the Director of Immunology in the Preclinical Department. Within the Preclinical Department, the predominant focus will be to generate data in support of bringing our innovative therapies to the clinic. Specifically, scientific work will focus on the use of primary cells and...

  • Senior Director, Strategic Marketing

    2 months ago

    Watertown, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role:...