Research Associate, Cell Therapy Process Development

Job Details

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Job ID:
24485

Location:
450 Brookline Ave, Boston, MA 02215

Category:
Research Laboratory

Employment Type:
Full time

Work Location:
Onsite:Up to 1 day remote/wk

Overview

Research Associate, Cell Therapy Process Development in the Cell Manipulation Core Facility will receive on the job training in order to perform a variety of tasks to provide the highest quality products for patients receiving more than minimally manipulated cellular therapy products on clinical trials.  These trials include Gene Therapy, Cancer Vaccines, Immuno-effector Cells including CAR-T cells, Induced Progenitor Cells (iPS), Mesenchymal Stromal Cells, Adoptive Immunotherapy and other innovative therapies.

The Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) assists DF/HCC members in developing new cell-based therapies for patients with cancer who are enrolled in novel therapeutic clinical research protocols. It also supports clinical research studies designed to evaluate the safety and efficacy of these novel treatments.  Please visit  https://cmcf.dana-farber.org

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. 

Responsibilities

PRIMARY DUTIES AND RESPONSIBILITIES:

Cell Processing

  1. Process more than minimally manipulated clinical human therapeutic cellular products by various methods using manual and/or automated aseptic technique in a regulated clean room environment according to standard operating procedures and applicable regulations.
  2. Achieve and maintain competency in routine procedures including:
    1. cell culture, including aseptic technique,
    2. cryopreservation/thawing,
    3. cell selection (Miltenyi CliniMACS),
    4. centrifugation and washing,
    5. manufacture gene manipulated products using semi-automated platform,
    6. labeling and transportation.
  3. Review and evaluate test results for acceptability including automated and manual cell counts, viability results, flow cytometry histograms, sterility testing results.
  4. Accurately enter and maintain records of procedures and enter data, both manually and on electronic data capture systems.
  5. Identify and evaluate problems related to product preparation, including issues with instrumentation, reagents, and documentation. Appropriately communicates outcomes, including escalating problems to supervisors and managers.
  6. Perform environmental monitoring of work area and laboratory.
  7. Participate in validations of new procedures, including working with vendors/trial sponsors
  8. Upgrade job skills to stay relevant and to progress in field.

Equipment

  1. Perform preventative and corrective maintenance of equipment and instrumentation. Identify the need for repair or service as required.
  2. Respond to REES alarm system alerts and document corrective actions appropriately.
  3. Participate in validation of new instruments/equipment.

 

QA/Regulatory Duties and Responsibilities

  1. Work within the cGMP and cGTP guidelines and adhere to all regulatory standards within the Cell Manipulation Core Facility, including:
    1. recognize and report deviations from standard operating procedures,
    2. initiate and document corrective actions when required.

 

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Capable of working in a fast-paced and rapidly changing environment and technology.
  • Ability to communicate and interact effectively with team members and stakeholders.
  • Capable of producing accurate results within strict time constraints.
  • Ability to apply critical thinking skills and possess good judgment, problem solving skills, and attention to detail.
  • Good analytical reasoning and ability to perform complex mathematical calculations using notation.
  • Knowledge of clinical Good Clinical Practice /research cGMP, cGTP.
  • Knowledge of lab safety and infection control.

Familiarity with operation & performance of basic lab equipment, e.g., centrifuge, microscopes, programmable freezers, etc.

Qualifications

Minimum Education:  BS/BA in a Biological Science, medical technology environment or related field required.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.  As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. 

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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