Research Associate

Position Summary 

We are seeking an innovative Research Associate to join our team developing novel cellular immunotherapies.  Genocea’s foundational technology, the ATLAS™ platform, is a high-throughput autologous cell assay that discovers T cell antigens thought to be important in fighting a patient’s disease.  ATLAS™ results are used to select validated neoantigens for a patient-specific vaccine, and upon population-based screening can identify antigens to include in a common vaccine. 

The successful candidate will help to advance Genocea’s approach to adoptive T cell therapy with clinical application in immuno-oncology and will help advance the next generation of ATLAS screening.  The Research Associate will contribute to execution and analysis of cell culture studies focused on optimizing processes for T cell expansion and ATLAS screening.  The position is lab-based and will work in collaboration with other team members.  The ideal candidate is a motivated, energetic, detail-oriented person who will design and carry out experiments with limited supervision.   Demonstrated hands-on experience with cell culture and immunological assays, such as ICS, ELISPOT, cell sorting, immunophenotyping and flow cytometry is a plus.

Primary Responsibilities

  • Develop method for isolation and expansion of human T cells including immune cell enrichment, T cell culture, APC differentiation and maturation and cryopreservation

  • Develop, optimize and qualify immunological and analytical methods to support process development such as ICS, proliferation, ELISA, cytotoxicity and multi-color flow cytometry assays

  • Follow new developments and technologies in the field of immuno-oncology

Competencies

  • Excellent ability to perform hands on experiments and maintain detailed documentation

  • Excellent organizational skills and ability to multi-task and embrace change in an extremely fast-paced environment

  • Independently motivated, detail oriented and good problem-solving ability

  • Ability to work as part of a team, collaborating and communicating effectively with members of other functional groups

  • A sense of humor is essential

Required Skills

  • A solid theoretical understanding of and experience with immunology techniques.  Assay development experience is a plus.

  • Ability to work independently and as a part of a cross-functional team with a positive attitude.

  • Strong verbal and written communication skills are required.

  • Ability to analyze data, draw conclusions, communicate results and compile technical reports.

  • Excellent record keeping abilities to adequately record and document analytical data.

  • Solid technical knowledge and hands-on experience.

  • Capacity to adapt, with a strong desire to learn new concepts and techniques

  • Experience with multi-color flow cytometry and flow data analysis is a plus

  • Excellent computer skills and experience with Microsoft Excel, Flow cytometry data analysis software, and Graphpad Prism are essential

Education Requirements

  • Master’s degree or Bachelor’s degree with a minimum of 1 years of experience in biopharmaceutical industry

*in-house recruiting only*

Director, Cell Therapy Development & Manufacturing

Position Summary

We are seeking an experienced and motivated Director for Cell Therapy Development & Manufacturing to be the key Scientific Leader for the CMC development of a novel personalized neo-antigen based T-cell therapy. This leader will drive the development and execution of the CMC plan with Contract Development and Manufacturing Organizations (CDMO).  The specific goals are technical development of cell activation, expansion, sorting, cryopreservation, and associated analytics such as cell phenotyping, viability/count.  Additionally, the leader will be responsible for GMP transfer and development of CMC sections for the IND.

The ideal candidate will have a Ph.D. with multiple years of industry experience in cell therapy development or biologics clinical development and commercialization. The candidate will have strong hands-on technical experience in cell culture process development as well as some experience in T-cell technical development. This is an exciting opportunity to enable novel life-saving cancer therapy development with an opportunity for innovation, professional growth, and a key role in driving company success.

Primary responsibilities

  • Develop technical CMC development strategy including cell activation, expansion, sorting, harvest/ cryopreservation, and analytical development of relevant technologies. 

  • Act as principal technical lead and provide oversight for technical and scientific interactions with CDMO and analytical vendors.

  • Collaborate efficiently and effectively with program team and across other Pharm Sci & Mfg groups to advance CMC activities. Work with supply chain and other technical leads for supply chain development.

  • Contribute to manufacturing strategy development, GMP readiness, technology transfer, capacity planning and clinical/commercial planning.

  • Develop CMC regulatory sections and lead discussions with regulatory agencies for technical meetings. 

Required Skills

  • Breadth of knowledge across cell therapy technologies, cell therapy manufacturing, cell characterization method development for T-cells or other primary cultures or stem cells.

  • Understanding of process development/qualification and GMP manufacturing of cell therapy and use of closed-systems, single-use or disposable technology for sterile and aseptic processing applications.

  • Working knowledge of flow cytometry, ELISAs, cell-based assays, and compendial methods for cell and gene therapy. Knowledge of chromatographic/mass spec methods is a plus.

  • Strong knowledge of global cGMPs and CMC regulatory framework for advanced therapies such as gene and cell therapy regulations.

  • Demonstrated track record of success in delivering on clinical development

  • Experience managing and mentoring scientists at contract or in-house laboratories.

  • Excellent organizational, management, communication and interpersonal skills. Ability to drive development through managing priorities, exerting influence, and driving decision making in a fast-paced team environment.

  • A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems. 

  • Willingness for up to 20% travel.

Education and Experience Required

  • Ph.D. in Life Sciences or Chemical Engineering. 

  • 8+ years industry experience in cell therapy and/or biologics operations

  • 5+ years’ experience in managing contract organizations for development or manufacturing activities

*in-house recruiting only*

Scientist, Cellular Biology and Immunology

Position Summary 

We are seeking an innovative Scientist to join our team developing novel immunotherapies for cancer.  Genocea’s foundational technology, the ATLAS™ platform, is a high-throughput autologous cell assay that discovers T cell antigens thought to be important in fighting a patient’s disease.  ATLAS™ results are used to select validated neoantigens for a patient-specific vaccine, and upon population-based screening can identify antigens to include in a common vaccine.  Our lead program, GEN-009, a personalized neoantigen vaccine, will soon be in the clinic.  The successful candidate will advance the next generation of ATLAS screening.  The Scientist will design, develop, execute and analyze T cell and dendritic cell culture studies to improve cell viability and recovery. In addition, the candidate will develop multicolor flow cytometry assays to determine the phenotype and functionality of cells.  The position is lab-based and will work in collaboration with other teams.  The Scientist will have the ability to independently troubleshoot technical issues and develop optimized processes and assays for critical tasks.  The successful candidate will have a strong background in immunology and T cell biology.  The scientist will have demonstrated hands-on experience with cell culture and immunological assays, such as ICS, ELISPOT, immunophenotyping, cell sorting and flow cytometry.

Primary Responsibilities

  • Develop method for isolation and expansion of human T cells including immune cell enrichment, T cell culture, APC differentiation and maturation and cryopreservation

  • Develop, optimize and qualify immunological methods to ATLAS development such as ICS, proliferation, cytotoxicity, cell sorting and multi-color flow cytometry assays

  • Experimental troubleshooting and development of improved workflows suitable for research and clinical application.

  • Design and perform DOE experiments to further characterize and optimize assays

  • Mentor junior members of the team

  • Follow new developments and technologies in the field of immuno-oncology.

Competencies

  • Excellent ability to perform hands on experiments, research, design, and organize project designs and maintain detailed documentation

  • Excellent organizational skills and ability to multi-task and embrace change in an extremely fast-paced environment

  • Independently motivated, detail oriented and good problem-solving ability

  • Ability to work as part of a team, collaborating and communicating effectively with members of other functional groups

  • Strong writing, editing and presentation skills required

  • A sense of humor is essential

Required Skills

  • Expertise and hands-on experience in mammalian cell culture with specific experience culturing primary T lymphocytes and dendritic cells is a requirement

  • Strong background in T cell biology and immunology is required, with background in oncology a plus

  • Demonstrated experience with immunological assays to assess and characterize T cell function such as cytokine secretion, cytotoxicity and proliferation

  • Experience with multi-color flow cytometry and flow data analysis is required, cell sorting experience a plus

  • Excellent computer skills and experience with Microsoft Excel, Flow cytometry data analysis software, and Graphpad Prism are essential

Education Requirements

  •   PhD in cellular biology/immunology with a minimum of 2 years related academic or industry experience

or

  •  MS in cellular & molecular biology/immunology with a minimum of 7 years related academic or industry experience

Preclinical Biostatistician

Position Summary

Genocea Biosciences is a biotechnology company focused on bringing lifesaving personalized cancer vaccines and immunotherapies to patients. Genocea’s revolutionary ATLAS™ platform is a high-throughput bioassay that utilizes a patient’s own immune system to identify T cell antigens that are critical to fighting disease. In the case of cancer, the ATLAS platform identifies which patient-specific tumor neoantigens are optimal for recognition by the patient’s immune system and inclusion in a vaccine or immunotherapy. A Phase 1/2a clinical trial of Genocea’s GEN-009 personalized vaccine is ongoing. Genocea is also developing a broad pipeline of cancer immunotherapy candidates including next-generation vaccines and cellular therapies.

We are seeking an experienced and motivated biostatistician to join our team. The successful candidate will provide significant statistical expertise in preclinical study design and data analysis in vaccine development and discovery research. They will also support statistical analysis of human immunogenicity assays to define positivity and responder criteria. The biostatistician will have the opportunity to work on developing novel statistical methodologies and improve current methodologies. They will also contribute to scientific advances through independent and collaborative research resulting in presentations and publications.

Primary Responsibilities

  • Serve as key biostatistician on preclinical study design and data analysis

  • Work with scientists to improve reproducibility and repeatability of existing assays using rigorous statistical methods

  • Develop and maintain good working relationships with research and clinical scientists, statisticians, computational biologists, and external collaborators as part of a multidisciplinary team.

  • Provide strategic input into the analysis of large and complex data sets from high throughput platforms

  • Maintain and expand expertise in various computing tools to leverage internal and external data sets

  • Application of various statistical approaches and innovative thinking to analyze immunogenicity assays using real and simulated datasets: define positivity and responder criteria, minimizes false positive and negative errors, improve reproducibility

  • Ability to define pros and cons of applying different statistical methods to clinical data.

  • Build out statistical capabilities and propose opportunities for productivity improvements and implementation plans.

  • Proactively seek input and review from other experts within and outside the group on various projects and research activities and share technical information when appropriate.

Required Skills

  • Proficient with statistical modeling and inferential statistics; actively seeks to acquire knowledge

  • Strong basis in statistical concepts and methodologies such as predictive modeling, mixed effects models, multivariate analysis, etc.

  • Exploratory data analysis and data visualization

  • Expertise in design of experiments and power/sample size calculations

  • Sound understanding of assay qualification and validation parameters and methodology, and statistical applications for assay development.

  • Strong statistical programming skills with R and/or python and SAS

  • Excellent communication, presentation and writing skills with an ability to explain complex technical details in simple language.

  • Good knowledge of drug development and FDA regulations pertinent to statistical analysis of assays.

  • Work well in a team as well as independently and be able to take a leadership role regarding statistical elements in various projects.

  • Candidate will need to understand the "language" of biology, immunology and vaccine development

  • Background in immunology and oncology would be a plus

  • Experience in applied Bayesian modeling would be a plus

Education Requirements

  • MS or PhD in Biostatistics, Statistics, Computational Biology or a related field

  • >1 year with PhD (or >3 years with MS) relevant post-graduate academic/industry experience collaborating within a cross-functional research team