Discovery / Research

Senior Research Associate, Biophysical Analytical Development Direct Hire MA

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Job ID: 16463 Direct Hire

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Our Cambridge, MA genome editing client uses CRISPR/Cas9 technologies to develop medicines for people with serious, genetically-defined diseases.  As the Analytical Development team continues to grow, this Biophysical Analytical Development Associate role was created to function as part of a larger Analytical Development group to generate and interpret analytical data from key techniques in support of the process development groups and release assays.

Responsibilities:

  • Perform analytical characterization of complex biomolecules, such as the nuclease protein and guide RNA/protein complexes, using HPLC based assays, static and dynamic light scattering and other biophysical techniques.
  • Collaborate with Process Development to generate biophysical characterization data.
  • Provide support for formulation and stability studies on nuclease protein and guide RNA / protein complexes.
  • Biophysical method development, optimization, and initial qualification.
  • Author and review protocols and reports. 
  • Maintain and characterize stocks of assays standards and controls.

Requirements:

  • Bachelor’s degree in life sciences with 5+ years of experience / Master’s degree with 3+ years of experience in biotechnology.  This role can be upgraded for a more experienced BS/MS candidate.  No PhD candidates will be considered.
  • Experience in HPLC/UPLC method development.
  • Familiarity with running qPCR/ddPCR, highly desirable.

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Senior Scientist, Pharmacology Direct Hire MA

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Job ID: 16443 Direct Hire

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Our Cambridge, MA genome editing client uses CRISPR/Cas9 technologies to develop medicines for people with serious, genetically-defined diseases.  The Biological Development group is seeking a Pharmacologist to collaborate with therapeutic area research, preclinical safety, biomarker, and clinical development to support research activities across multiple programs for cell therapy.

Responsibilities:  

  • Lead the strategy, planning and execution of activities related to preclinical pharmacology.  
  • Strategy for and oversight of animal model development and characterization in the areas of of ophthalmology and neurology.
  • Design experiments and develop assays critical to understand in-vivo therapeutic activity, efficacy, and PK/PD properties.
  • Perform preclinical proof-of-concept and interact with clinical development team to design and supervise IND-enabling studies.
  • Experience managing studies remotely through CRO collaborators.
  • Authoring or review of pre-clinical pharmacology-related section of IND.

Requirements:

  • PhD in Pharmacology or Life Sciences related field.
  • Minimum of 8+ years in biotechnology/pharmaceutical industry experience.
  • Ability to develop/evaluate disease models for efficacy studies.
  • Experience in biologics, cell or gene therapy is highly preferred.

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Director/Associate Director, Pathology Direct Hire MA

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Job ID: 16442 Direct Hire

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Our Cambridge, MA genome editing client uses CRISPR/Cas9 technologies to develop medicines for people with serious, genetically-defined diseases.  The Biological Development team is seeking an innovative leader to serve as a program pathologist providing the pathology aspect of the design, conduct, and interpretation of nonclinical studies.  The histopathology group works across multiple therapeutic areas including ophthalmology, oncology, neurology, and hematology to support activities ranging from early drug discovery to early development. 

Responsibilities:

  • Develop the platform of molecular pathology, histology, investigative pathology/toxicology, providing a comparative medical perspective to drug discovery and development.
  • Direct and lead the development of IHC and IF methods to characterize the expression of transgenes.
  • Serve as a subject matter expert in Immunohistochemistry and other tissue-based assays for research and development teams.
  • Build the state-of-the-art histo/pathology platform for evaluating and characterizing the preclinical species modified by in vivo editing gene therapy or ex vivo edited cell therapy.
  • Oversee junior scientist/histologists by providing training and technical guidance.  
  • Collaborate with internal and external partners to develop pathology assessment scheme for potential clinical candidates, review external pathology report and to ensure proper integration into study reports.

Requirements:

  • DVM and/or PhD in comparative pathology (ACVP board certification preferred) with 12+ years as a veterinary pathologist.
  • Extensive understanding of efficacy and safety evaluation of gene or cell therapy programs.
  • Collaborations with Contract Research Organizations to conduct GLP toxicology studies.
  • Evidence of direct experience authoring study reports for regulatory submission.

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Scientist I/II, Protein Engineering Direct Hire MA

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Job ID: 16440 Direct Hire

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Our Cambridge-based client is a highly-regarded cell/gene therapy company and they are seeking an experienced Protein Engineering Scientist to join their Nuclease Research and Discovery team in Seattle, WA. You will collaborate with and help other teammates build megaTAL nucleases and develop technologies to enhance and expand their gene editing program. The main function of this role is to assess yeast surface display, high-throughput molecular biology, computation-based library design, and mammalian cell assays.

Responsibilities:
•  Utilizing protein engineering techniques to improve on existing techniques and introduce new tools for improving the platform on nucleases.
•  Oversee a team of associate scientists to meet scientific goals
•  Collaborate with multiple teams including colleagues at the East Coast location.

•  Strong presentation skills as there will be regular presentations to internal and external audiences.

Requirements:
•  PhD in Bioengineering, Cell or Molecular Biology or related field. Post-doc experience welcome but not required.
•  Technical skills including flow cytometry, yeast and bacterial molecular biology and cloning; PCR

•  Experience of protein engineering approaches; yeast surface display, library design and construction, next generation sequencing.
•  Strong communication skills and ability to collaborate with internal and external colleagues.
 

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Principal / Senior Research Associate, Immunotherapy Direct Hire MA

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Job ID: 16391 Direct Hire

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Principal Research Associate, Immunotherapy

Our Cambridge, MA genome editing client uses CRISPR/Cas9 technologies to develop medicines for people with serious, genetically-defined diseases. The immunogenetics team is seeking an immunologist/molecular biologist with expertise in genetic engineering of hematopoietic cells.  The ideal candidate will have experience with mammalian cell culture, and ideally some exposure to isolating and propagating human effector cells.

Responsibilities:

  • Create protocols for gene editing including delivery methods, cell conditions, scale up, and multiplexing
  • Use in vitro functional assays and in vivo tumor models to characterize genetically modified primary cells
  • Collaborate with other lab members to main lab equipment and reagent inventory
  • Present experimental data to internal and external audiences

Requirements:

  • B.S. or M.S. in molecular or cell biology or related field with 3-10 years’ experience
  • Experience with mammalian cell culture, hematopoietic cells is a plus
  • Technical background including multi-color flow cytometry and flow cytometric analysis
  • Hands-on in vivo skill set including SC and IV injections
  • Experience troubleshooting assays

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Head of Translational Development Direct Hire MA

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Job ID: 16382 Direct Hire MA

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Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This role is with a mid-size company and they have a culture that can't be beat. This critical hire will lead the Translational Development team to generate the hypotheses, mechanism-of-action, and pharmacology data that fuel the company pipeline. They are seeking an experienced leader to spearhead efforts to translate innovative therapies safely from research to the clinic and then the marketplace.  Are you looking to make a significant impact for patients afflicted with rare diseases and cancer?

The main function of this role is to shape and scale their expanding translational pharmacology function, including translational bioassays and pharmacology/pharmacokinetics.  In this role, you will lead a team of managers, scientists and associates responsible for pharmacology/PK analyses and the development and validation of bioanalytical assays for PK, PD and immunogenicity assessments for all programs in the pipeline. 

Responsibilities include but are not limited to;
•  Apply principles of Clinical Pharmacology to drug development of cell and gene therapies.  Will be responsible for strategy, design, execution, analysis, interpretation and reporting of preclinical and clinical pharmacology-related studies.  Previous cell & gene therapy experience preferred but not required - see qualifications below.  
•  Ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exists to support filings for first-in-human administration.
•  In collaboration with pharmacometrics and biostatistics groups, lead development of analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize dosing.
•  Preparation of regulatory documentation and participation in meetings with regulatory agencies as the Clinical Pharmacology representative.
•  Recruitment, development and retention of high-performance personnel.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have an advanced degree (PhD, DVM, or MD) or relevant training in clinical pharmacology, pharmaceutical sciences, or related discipline with 10+ years of experience in building, scaling and integrating preclinical and clinical pharmacology capabilities.  Must have a record of significant contributions to INDs/CTAs, Regulatory Agency interactions, BLAs/MAAs, drug approvals, and peer reviewed publications.  Experience in T-cell therapeutics (CAR-T, TCR, etc.) and/or cell & gene therapy is preferred but not required.  At minimum, qualified candidates must have experience with the development of biotherapeutics.  Must be able to demonstrate the ability to build and lead a world-class preclinical and clinical pharmacology function, including extensive outsourcing relationships and organizational growth and design strategy.   

Must be authorized to work in the US indefinitely to be considered.  Relocation assistance available for qualified candidates.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
 

Scientist, Correlative Sciences, Oncology Direct Hire MA

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Job ID: 16354 Direct Hire

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Our client is a highly-regarded cell/gene therapy company in the greater Boston area, and they are seeking a Scientist with a cancer immunology background to join their correlative sciences team.  The role works cross-functionally with research, clinical, and pharmaceutical sciences to advance their gene therapy candidates. 

Responsibilities:

  • Create new methods to determine safety, efficacy, and mechanisms of actions, resistance and relapse in cell therapies.
  • Develop assays to assist preclinical development and biomarker analysis for CAR/TCR trials.
  • Collaborate with internal teams and coordinate assay transfers between the preclinical team or CRO.
  • Work cross-functionally with other teams to meet project timelines
  • Compile data for technical reports that can be used transitioning to Process Development

Requirements:

  • PhD in biology, cell biology, molecular biology, cancer biology, immunology, biochemistry or related discipline with 2+ years of antibody discovery experience
  • Post-doctoral or related industry experience in cancer immunology
  • Technical skills including but not limited to T cell functional assays, development of immunoassays, FACS, PCR, and next generation sequencing 
  • Knowledge of statistical analysis methods and computer skills including Excel, Flow cytometry data analysis software, and GraphPad Prism.

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Director, Cellular Immunotherapy Direct Hire MA

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Job ID: 16338 Direct Hire MA

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Our client is a highly-regarded cell/gene therapy company in the Greater Boston Area, and they are seeking an experienced, highly-motivated leader to join their research and discovery team to help define and execute on the pre-clinical pipeline of their oncology products!   You will report to the Senior Director and lead high functioning teams to engineer T cell products that could be the next therapy for cancer patients.

The main goal of this group is to bring modified cells through phase I clinical development.  To achieve this goal, the Director, Cellular Immunotherapy, you will lead a team to engineer cells of the hematopoietic system that mediate anti-cancer activity. 

Responsibilities:

  • Oversee resources to efficiently manage continued excellence for innovative pipeline products 
  • Evaluate the efficacy and safety of preclinical models and the development of early research. 
  • Recognize new technology that can be implemented to improve the therapeutic potential of gene-modified hematopoietic cells for Cellular Immunotherapy.

Requirements:

  • MD or PhD in Immunology, Cell/Molecular Biology, or related field.
  • 8+ years of relevant experience in immunology, I/O, or autoimmunity.
  • Extensive experience leading a team of Scientists in Biotech/Pharma.  Strong mentoring skills and self-awareness. 
  • Knowledge of T-Cells and current literature.  Highly desirable TCR/CAR-T background. 
  • Experience executing decisions on cellular immunotherapy approaches.

Formal descriptions can be supplied for interested candidates.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Must be authorized to work in the U.S. indefinitely to be considered.

Scientist, Translational Bioassay Direct Hire MA

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Job ID: 16239 Direct Hire MA

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Our client is a highly-regard cell and gene therapy company in the greater Boston area and they are seeking an experienced MS/BS candidate as a Principal Associate Scientist to join their Translational Bioassay group! You will work across multiple research areas providing a variety of technical responsibilities to supporting the growing need for preclinical and clinical assay support. A focus on qualifying bioanalytical methods for platforms such as qPCR, HPLC, Flow Cytometry, and MSD, conduct biological sample analysis, prepare reports, and present findings to cross-functional project teams

Responsibilities:

  • Develop, qualify, and execute preclinical and exploratory clinical translational assays.
  • Analyze, interpret, organize and report experimental data
  • Work cross-functionally to execute process while managing work flow independently.
  • Drive the design and development of new methods and techniques

Requirements:

  • BS with 10+ years of relevant experience or MS with 7+ years of relevant experience with a strong scientific background (Biology, Biochemistry, Immunology)
  • Experience in the development of PD, PK, and Biomarker assays is required.
  • Exposure to data analysis method or software
  • Background in cell and molecular biology, immunology or immune-oncology

Senior Scientist, Immunotherapy, CAR/TCR Direct Hire MA

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Job ID: 16182 Direct Hire MA

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Cambridge, MA:  Our genome editing client uses CRISPR/Cas9 technologies to develop medicines for people with serious, genetically-defined diseases.  The immunogenetics team is seeking a molecular biologist/immunologist with a background in genetic engineering of hematopoietic cells.  Other responsibilities include but are not limited to:

  • Serve as a Group Leader on the immunogenetics team to lead in the generation and characterization of novel cell therapy products for cancer.
  • Build a team to develop a new class of immuno-oncology products and to derive characterize genetically modified human effector cells and evaluate strategies to improve the efficacy of cellular therapies.
  • Strategize to execute in vitro functional assays, and design in vivo tumor treatment models
  • Collaborate with other teams to innovate and optimize advanced cellular engineering that integrates tumor antigen recognition elements with somatic cell reprogramming through genome editing.
  • Manage timelines to meet program objectives.

Requirements:

  • PhD in cancer cell biology, immunology, or related field
  • Minimum of 5-8+ years post-doctoral research or equivalent industry experience