Research Associate, Translational Immunology

Position Summary

We are seeking a highly motivated Research Associate to join our translational medicine team. 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. Our lead program, GEN-009, a personalized neoantigen vaccine, is in the clinic. The successful candidate will be an active member of a team that supports the evaluation of immunogenicity and efficacy of oncology vaccines in clinical trials.

The Research Associate in Translational Immunology will assist in design and execution of complex immune-monitoring experiments with human clinical samples for GEN-009, using established and novel procedures. The candidate will be expected to be in the laboratory to perform experiments and clinical testing with other team members. The candidate must have a strong, positive work ethic. The ideal candidate is a dedicated, energetic, detail-oriented person.Demonstrated hands-on experience with cell culture and immunological assays, such as ICS, ELISPOT, cell sorting, immunophenotyping and flow

Primary Responsibilities

  • Testing of Genocea clinical trial samples in immunogenicity assays

  • Design, develop and qualify/validate immunological assays to characterize vaccine therapeutic responses including: ELISPOT, multi-color flow cytometry and intracellular cytokine staining

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

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

  • Prior experience in performing immunoassays and hands on experience in cell culture

  • 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.

  • 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

Senior Manager, Supply Chain & Logistics

Position Summary

This role will oversee and manage Genocea’s Supply planning and logistics for personalized medicine.   This includes but not limited to communicating supply plans based on clinical demand; Partnering with other functions to support development of COGS models and associated analytics to drive continuous improvements initiatives; key point person for Pharma Sci to manage and maintain production schedules and, budgets as well as evaluate and develop long and short term supply scenarios. This position will also be responsible for managing CMO/CRO relationship with global storage and logistics partner including inventory management for GMP materials including personalized drug substance, drug product and finished goods.

Primary Responsibilities

  • Communicate regularly with program team and e-team to track risks and mitigations, updates in PM tracking systems, project management gaps

  • Meet with functional lead to discuss day to day operations and track progress on Program deliverables and ensure that action items are being addressed in a timely manner.  Summarize and report progress to Program Lead and leadership as requested.

  • Responsible for overall management of production schedules, forecasting and end-to- end supply chain planning.

  • Deliver robust and comprehensive supply models; Identify risks and constraints to achieving supply.

  • Build and maintain communication channels among all groups associated with the Supply Chain through information sharing, thought leadership, and tactical and strategic planning

  • Generate reports for project documentation for internal/external communication (written reports, presentations etc.) to various functions including senior management.

  • Ensure successful and timely delivery of all project deliverables within area of responsibility

Required Skills

  • Solid experience in Supply Chain function with knowledge of S&OP, global logistics and management of CRO/CMOs.

  • Strong analytical and problem-solving skills with strong attention to detail

  • Knowledgeable in biologics processes/cycle times for drug substance, drug product, secondary packaging and labeling.

  • Ability to work with cross-functional teams to develop and support long range planning efforts (scenario planning and analytics for impact assessments)

  • Experience in and/or a solid understanding of inventory management (drug substance, drug product, etc.)

  • Experience with CMC teams, as a lead or a team member

  • Demonstrated experience managing GMP operational and business activities at CROs/CMOs

  • Knowledge of global trade compliance landscape (local and regulatory) as well as experience with import/export requirements for pharmaceutical/biotechnology products at clinical and commercial stage.

  • Expertise in supply chain software.

Education & Experience

  • A B.S. degree in business or a scientific discipline with 10+ years of experience, MBA preferred.

  • 5+ years of global supply chain experience in the area of supply planning and/or logistics for pharmaceutical clinical and commercial products.

 

Purchasing Administrator

Position Summary

The Purchasing Administrator will be responsible for administrating all activities needed to support the procurement process. The candidate will be responsible for the ordering of materials, supplies, and/or equipment and assist the Laboratory Manager with inventory control.  This role includes analysis of purchasing trends, pricing negotiation, and communication with vendors. The candidate will provide customer service to internal stakeholders and interact with the scientific and administrative staff to process requests in a timely manner. This is a contract, 6-9 month position with the potential to become permanent.

Primary Responsibilities

The successful candidate will be responsible for day to day purchasing transactional activities including but not limited to:

  • Processing purchase requisitions and purchase orders within NetSuite ERP

  • Tracking purchase order confirmations, shipment details and reconcile receipt of materials with purchase orders

  • Analyze spending data to identify opportunities to increase economies

  • Monitoring usage history of goods & inventory stock items in coordination with Laboratory Operations

  • Coordinating with suppliers on pricing contracts and reorders of goods and services.

  • Maintain inventory for office supplies  

  • Work with Accounts Payable to support end to end Procure-to-Pay functionality

  • Prepare & negotiate equipment service contracts with Lab Operations

Competencies

  • Ability to perform in dynamic and evolving corporate environment

  • Provide strong customer service in a timely manner

  • Ability to negotiate pricing and service contracts

  • Ability to accurately support high volume of transactions and rapidly solve problems as they arise

  • Must interact well in a team environment and display a positive customer service attitude

Required Skills

  • Previous procurement process experience and be accustomed to using a computerized system for processing purchase orders

  • Be skilled at using Microsoft Excel, Word and PowerPoint

  • Demonstrate clear and professional verbal and written communication

  • Work and communicate effectively in a matrix environment

  • Be detail oriented and possess excellent organizational skills

Education & Experience

  • A Bachelor’s degree with 1-2 years of purchasing experience in the biotechnology field is required.

  • Familiarity with NetSuite or similar ERP system is preferred. 

Program Lead

Position Summary

The successful candidate will be responsible for leading a multi-function team through the clinical development of a novel T-cell based vaccine.  The Program Lead (PL) will, along with the Genocea leadership, establish the objectives for the clinical phase of the product development. The PL will work with other functions, including pharmaceutical sciences & manufacturing, regulatory, research, statistics, commercial and clinical operations, in a matrixed project team, to achieve the objectives.  This is a high-visibility leadership position and includes identifying and forging internal and external partnerships to advance the project objectives.

Primary Responsibilities

  • Collaboratively develop clinical program objectives with Discipline Leaders and in agreement with corporate goals and overall Product Development Objectives

  • Lead the multi-function Product Development Team: reaching agreement on the Product Development Plan, execution of the Plan; and communicate to the Executive Team

  • Develop the product development budget, milestones and timelines for the execution of the Clinical Program. Communicate output to Executive Team

  • Works with Program Team members to harmonize the Clinical Program with the overall Product Development Plan

  • Works with Project Managers and Clinical Operations to assure effective conduct of clinical trials, on budget and on time,

  • Works with Pharmaceutical Sciences & Manufacturing and Research to assure effective technical development and manufacturing operations development to supply for clinical trials, on budget and on time

  • Give presentations and lead discussions of data at internal meetings including Program Team, Executive Review meetings. Also may present to external audiences including consultants, KOLs, investigators, and regulatory meetings as necessary

  • Establishes relationships with key external experts, consultants, opinion leaders and regulators

Required Skills

  • Experience in and strong understanding of clinical and CMC development of drug and/or biologic therapeutics, oncology preferred

  • Demonstrated ability to lead a multi-function team within a matrix environment toward successful completion of program objectives in an inclusive and collaborative fashion

  • Organizational and communication skills to effectively articulate objectives, progress, and risks to Executive and Program Team members

  • Demonstrated problem solving capabilities, and ability to think creatively to efficiently identify and utilize required resources

  • Familiarity with regulatory requirements and ICH guidelines for development of new therapies

  • Solid understanding of all aspects of clinical and CMC product development, clinical trial design, and execution

  • Previous experience in drug development in one of the fields of vaccines, immunology, or oncology is a plus.

Educational Requirements

  • Advanced degree desirable (MD/PhD/PharmD, or other), but candidacy may be supported by demonstrable significant hands-on experience in program leadership roles (5 to 10 years of clinical development including team leadership).

  • Significant prior experience with drug or biologics development programs, preferably through all stages of development.

Scientist, Platform Development

Position Summary

Genocea Biosciences is an immuno-oncology biotechnology company focused on bringing personalized cancer vaccines to patients. Using our revolutionary ATLAS™ platform we are creating new lifelines for cancer patients by listening to and learning from their immune system.  ATLAS™ 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.

 The Synthetic Biology team is seeking an exceptionally creative scientist with expertise in advanced molecular biology and cell culture techniques to lead the development of novel antigen screening strategies.  The ideal candidate will generate innovative solutions by drawing inspiration from diverse fields of biology, to design, test, and lead the implementation of these strategies.  Effective communication skills will be key to work well within a dynamic and team-oriented environment.

Primary Responsibilities

  • Drive the design of novel antigen screening strategies from the ground-up by engaging an interdisciplinary team of molecular, cellular, and computational biologists.

  • Independently plan and execute experiments to support the development of robust screening strategies.

  • Identify and contribute to experiments designed to increase the efficiency and throughput of ATLAS™ .

  • Generate ATLAS™ libraries in collaboration with other team members, as needed.

  • Present scientific and technical data both internally and externally.

  • Mentor junior team members at the bench with the potential for management responsibility in the future.

  • Ensure scientific integrity and documentation of experimental data to meet standards suitable for intellectual property, FDA submissions, and publication

Required Skills and Experience

  • Expertise in advanced synthetic biology approaches (reporter systems, DNA barcoding, etc.) and molecular biology techniques (NGS, gene variant library design and cloning, qPCR, etc.).

  • Experience in a high-throughput screening environment.

  • Hands-on experience in mammalian cell culture. Preferably with culturing of primary T cells and APCs.

  • A demonstrated record of identifying and developing creative approaches to difficult problems.

  • Knowledge of bioinformatics, genetic and genomic analysis, data and literature mining, disease and biological pathway analysis.

  • Strong writing, editing, and presentation skills.

  • The ability to collaborate within a matrixed environment.

  • Excellent organizational skills with the ability to multi-task in a fast-paced dynamic environment.

  • Knowledge of laboratory automation and/or flow cytometry/FACS is a plus.

  • Experience in immunology and/or oncology is a plus.

Education Requirements

  • Ph.D. in Molecular Biology, Cellular Biology, Genomics or other related fields with relevant post-graduate research experience.

  • An additional 1 – 3 years of industry experience is preferred.

Scientist, Immunology Assay Development

Position Summary

We are seeking an innovative Scientist to join our team developing novel immunotherapies for cancer.  Our lead program, GEN-009, a personalized neoantigen vaccine, is in the clinic.  The Immunology/Assay Development Scientist will be expected to design and execute complex immune monitoring experiments with human clinical samples utilizing established and novel procedures. The candidate will have demonstrated hands-on experience with assays, such as ICS, ELISPOT, and other cell-based immunological assays such as immunophenotyping.  He/she will have experience with assay development, troubleshooting, qualification, validation and clinical testing.  The successful candidate will supervise a team that supports the evaluation of immunogenicity and efficacy of oncology vaccines in clinical trials. The candidate will demonstrate effectiveness as a team member and write experimental and clinical protocols and reports for senior management.  The candidate will be expected to be in the laboratory to perform experiments and clinical testing with other team members.  The candidate must have a strong, positive work ethic and be highly collaborative with other group members.  The successful candidate will have a strong background in immunology and T cell biology. 

Primary Responsibilities

  • Select appropriate methodologies and design, develop, and qualify/validate applications/assays in support of vaccine research projects.  Design and run the development of assays to evaluate cell-mediated immune responses in clinical samples. Propose, plan and implement/execute experiments with minimal supervision.

  • Provide technical resources for immunology method development, optimization, implementation and validation.

  • Ability and willingness to work in the laboratory to perform human clinical testing and meet deadlines.

  • Work collaboratively with Translational Medicine and other team members to understand their deliverables to achieve organization goals.

  • Demonstrated experience with method development, qualification and validation is necessary.

  • 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

  • Demonstrated experience with direct management of multiple reports is essential.

  • Ability to hire, train, and mentor staff

  • A sense of humor is essential

Required Skills

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

  • Demonstrated experience with clinical testing

  • Experience with assay development and qualification

  • Demonstrated experience with immunological assays to assess and characterize T cell function such as ELISPOT, 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 immunology with a minimum of 2 years related industry experience

 

 

Director, Regulatory Affairs

Position Summary

The Director of Regulatory Affairs is expected to oversee and manage the broad regulatory obligations, expectations, strategic and execution needs of the company. They will work in collaboration with internal and external experts to assure planning, preparation and management of regulatory submissions. They will partner with the functional areas on various projects including CROs, CMO/development partners, and consultants in the planning, organizing, and preparing of regulatory strategy and documents for submission to governmental regulatory agencies. For the appropriate candidate, this role can also serve as primary liaison with regulators and can help build the regulatory department as the company grows. While this person may have a specific area of regulatory expertise (e.g. CMC, clinical…), responsibilities will extend across the entire regulatory portfolio with the help of consultants.

Primary Responsibilities

  • Act as liaison between Regulatory Affairs and other functional areas including CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies.

  • Represent Regulatory Affairs in cross-functional team meetings, including Product Development Teams

  • Responsible for managing regulatory compliance, identifying regulatory issues relevant to products in development and providing accurate and timely recommendations to management and Project Teams

  • Actively contribute to the clinical and CMC development strategy and implementation of regulatory strategy for assigned projects

  • Accountable for preparing, coordinating, and managing various regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival), and control and management of documents.

  • Provide thoughtful & accurate comments during document review (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.), mindful of regulatory/ICH guidance/requirements pertaining to document content.

  • Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).

  • Provide regulatory support for CMC operations activities (e.g., strategy for process/analytical development, process control strategy, justification of specification, stability plan, review of essential technical documents, and development and review of CMC section, etc.).

  • Assure the timely development and submission of INDs. Monitor company progress toward fulfillment of regulatory commitments. Manage Regulatory Timelines and submission requirements in order to provide metrics to senior management.

  • Track and evaluate changes to regulatory requirements and guidelines as they impact development of our products, and review and communicate current & emerging regulatory requirements.

  • Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.

  • Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Clinical, Quality Assurance or other departments.

Required Skills

  • Excellent communication and organization skills.

  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.

  • Ability to evaluate and interpret regulatory documents and determine appropriate action

  • Ability to provide regulatory input to other departments on relevant topics and issues

  • The ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders).

  • Working knowledge of project management tools, i.e. MS Project, Microsoft Timeline, Proficient with Microsoft Office applications, Adobe and document management templates.

Competencies

  • Knowledge of all FDA requirements pertaining to the control and submission of regulatory documents for biologics/drug approval

  • Solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format.

  • A working knowledge of FDA and regulations relevant to the development and approval of new therapeutic agents, biologics and vaccines

  • Demonstrated experience in FDA interaction and documentation preparation.

Educational Requirements

  • Minimum of a Bachelor’s degree in a scientific field; Advanced degree desirable

  • A minimum of 7 years of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility. 

  • Experience with biologics/vaccines and regulatory submissions related to cell and gene therapy, or personalized drugs is preferred

  • Domestic travel may be required

Senior Computational Biologist

Position Summary

Genocea finds targets of T cell responses to discover and develop life-changing medicines. We have a pipeline of novel vaccine and immunotherapy programs that stimulate the T cell arm of the immune system, which is critical to generating protective immune responses against a wide array of diseases. We design our medicines using ATLAS™, our proprietary technology platform.  Our platform has the potential to revolutionize vaccines and immunotherapies for a range of cancers, infectious diseases and autoimmune diseases.

We are seeking a talented and highly motivated Senior Computational Biologist, to provide technical expertise and leadership to drive advanced computational methods enabling vaccine discovery for oncology indications. The successful candidate will possess the ability to work within a multidisciplinary discovery team to lead development and implementation of innovative computational tools to facilitate novel vaccine development.

Primary Responsibilities

  • Work within an interdisciplinary team of molecular biologists, cellular biologists, computational biologists and software engineers focused on developing novel vaccine candidates with our ATLAS™ antigen discovery platform

  • Lead the development and implementation of automated methods, analytical tools and software to deliver insights and hypotheses from multi-dimensional biological data sets

  • Process, analyze and interpret high volumes of cellular profiling data as part of internal and external scientific studies

  • Integrate innovative analysis and visualization tools for multi-omics data sets, in the context of studies of cancer-patient samples

  • Present scientific and technical data to both internal and external scientific colleagues in a clear and cohesive manner

  • Work independently and prepare timetables, deliverables, and project schedules

  • Lead a team of computational scientists responsible for multi-dimensional research and clinical data analysis

Competencies

  • Strong scientific understanding of cellular biology, molecular biology and genomics is desirable, including experience with transcriptomics, proteomics or cellular profiling data 

  • Demonstrated expertise in delivering insights and hypotheses from complex multi-dimensional biological data in a biomedical context

  • In depth knowledge of relevant public and proprietary databases, methods and tools (NCBI, UCSC Genome Browser, TCGA)

  • Knowledge of programming, scripting and statistical languages. Experience with R and Python is preferred

  • Demonstrated ability to present data to a multidisciplinary audience in a clear and cohesive manner

  • Ability to work independently in a multidisciplinary, fast-paced, dynamic and results-oriented environment

  • Excellent teamwork, time management and organizational skills

  • Experience growing a team, and managing junior colleagues also a plus

Education Requirements

  • Ph.D. or M.Sc. in Bioinformatics, Computational biology, Computer science or other related fields with 5+ years of relevant post-graduate research experience, preferably including biotech/pharma experience

  • Experience in cancer or immunology research is preferred