Director, Operations

Genocea Biosciences is looking for a motivated biotechnology professional to be the head of Facilities and Operations, including oversight of the security and purchasing functions. The individual will be responsible for managing vendors, facilitating projects to streamline facility operations, and maintenance of office and laboratory infrastructure and equipment. The person in this role will work closely with the landlord and internal and external building management teams, execute projects related to office and lab expansion, and ensure compliance with local and federal licenses and permits. 

Primary Responsibilities

  • Strategic and tactical lead for short-term and long-term infrastructure development and other capital projects for supporting company growth, including lab and office design and construction

  • Manage facilities encompassing office, vivarium and laboratory spaces; including management of facility vendors for regular maintenance, upgrades and renovations

  • Oversee the supervision of the vivarium and its staff, including participation in the IACUC

  • Oversight of the purchasing function including optimization of the procurement processes and coordination of material and resources allocation.

  • Develop strategies for space planning, fulfilling EH&S requirements, building/office/lab access and programs, and establishing/maintaining security policies

  • Build and maintain operations and facilities budget and forecasting, and oversee purchasing, staffing, contract negotiations and vendor management

  • Ensure service contracts and robust laboratory management programs are in place to support continued growth

  • Maintain and enforce compliance with local, federal and international licenses and permit requirements

  • Collaboratively manage the Operations committee, chaired by the CFO, to ensure cross-functional alignment

Competencies

  • Strategic and tactical lead for short-term and long-term infrastructure development and other capital projects for supporting company growth, including lab and office design and construction

  • Manage facilities encompassing office, vivarium and laboratory spaces; including management of facility vendors for regular maintenance, upgrades and renovations

  • Oversee the supervision of the vivarium and its staff, including participation in the IACUC

  • Oversight of the purchasing function including optimization of the procurement processes and coordination of material and resources allocation.

  • Develop strategies for space planning, fulfilling EH&S requirements, building/office/lab access and programs, and establishing/maintaining security policies

  • Build and maintain operations and facilities budget and forecasting, and oversee purchasing, staffing, contract negotiations and vendor management

  • Ensure service contracts and robust laboratory management programs are in place to support continued growth

  • Maintain and enforce compliance with local, federal and international licenses and permit requirements

  • Collaboratively manage the Operations committee, chaired by the CFO, to ensure cross-functional alignment

Required Skills

  • 12+ years of experience managing facilities operations for office and laboratory spaces

  • Track record of vivarium oversight and management

  • Demonstrated experience setting and implementing short and long-term infrastructure strategies

  • Experience with budget management and contract negotiation, vendor management and software to facilitate purchasing

  • Working knowledge of local, federal, and international licenses and permit requirements

  • Extensive experience with automation and engineering preferred

  • Knowledge of Excel, PowerPoint, NetSuite, LIMS systems

Education Requirements

  • Bachelors of Arts or Bachelors of Science

Clinical Sample Associate

Position Summary

Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines to a wide range of infectious disease pathogens. We are seeking an experienced Sample Coordinator to support the clinical assay team by receiving, validating, storing and tracking temperature sensitive clinical trial samples. The individual will, on occasion, be required to process blood samples and assist in laboratory assays and related activities.

Primary Responsibilities

  • This position will maintain quality control, inventory and organization of samples. The Sample Coordinator will be responsible for receipt of potentially infectious/biohazardous samples from clinical studies and managing samples through entry and tracking in an electronic Laboratory Information Management System (LIMS). 

  • Must perform a variety of tasks related to sample management in adherence with standard operating procedures and be responsible for documenting and retention of source materials.

  • Blood processing and assistance in a variety of laboratory functions

  • Participate in general housekeeping duties in the lab, such as autoclaving, cleaning, waste disposal, etc.

  • Attend team or group meetings

Competencies

  • Excellent communication, problem solving and analytical skills.

  • Strong organization and ability to work in a collaborative environment.

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

  • Displays solid technical knowledge and has hands-on experience

Required Skills

  • Proficient with MS Office and significant experience with electronic database systems.

  • Knowledge of good laboratory practices. Strong attention to detail and ability to handle multiple tasks simultaneously.

  • Experience pipetting human specimens and maintaining sterile technique

  • Experience with LIMS database and Excel-based Macros a plus.

  • Knowledge of immunology and immunological assays a plus.

Education and Experience Required

  • Bachelors or Associates degree with 2 years’ experience with database systems

Senior Scientist, Cell Therapy CMC

Position Summary

We are seeking an experienced and motivated Senior Scientist for T cell process development and GMP manufacturing for a personalized neoantigen-based T-cell therapy product. The successful candidate will focus on the day-to-day process development and clinical manufacturing activities with Contract Development and Manufacturing Organizations (CDMO).  The candidate should be detail oriented and have strong understanding and technical knowledge of T cell process development activities, including sorting, activation, expansion, cryopreservation, and associated analytics including multicolor flowcytometry for cell phenotyping.  Additionally, the candidate will play a major role for tech transfer for GMP manufacturing and writing of SOPs, batch records and CMC sections for the IND, as well as in ensuring clinical supply of the cell therapy product.

The ideal candidate must have experience in T cell therapy development in industrial settings with hands-on T cell culture process development with GMP understanding.  Experience with cell therapy analytical assay development would be recommended but not required. This is an exciting opportunity to change people’s life by developing novel life-saving cancer therapy with opportunity for professional growth, and company success.

Primary Responsibilities

  • Develop plan for day-to-day technical CMC development activities including T cell sorting, activation, expansion, harvest/cryopreservation.

  • Experience with flow cytometry and analytical assays development of relevant technologies would be recommended.  

  • Under the guidance of Director, Cell Therapy and Manufacturing act as technical lead and provide oversight for technical interactions with CDMO and analytical vendors.

  • Work closely with other members and groups of Pharm Sci & Mfg team to advance CMC activities. Work closely with supply chain and others for supply chain development.

  • Develop plan with superiors for for manufacturing development, GMP readiness, technology transfer, capacity planning and clinical/commercial manufacturing.

  • Draft, CMC sections and participate in quality and regulatory meetings. 

  • Provide technical expertise to ensure successful clinical supply.

Required Skills

  • Clear understanding and experience of aseptic techniques for primary human cell cultures, process development/qualification and GMP manufacturing.

  • Experience with single use technologies, tools for cell culture, current understanding of multi-color flow cytometry, ELISAs, cell-based assays.

  • Knowledge of CMC regulatory framework for advanced cell therapy regulations.

  • The candidate should have high planning skills for day-to-day activities and excellent communication and interpersonal skills.

  • 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

  • BS in Biology, Chemical engineering or Biomedical engineering with 10+ years of experience or MS in Biology or equivalent with 7+ years of experience or Ph.D. in Biology or equivalent with 5+ years of experience.     

  • At least 3 years of hands-on experience with T cell process development with understanding of GMP manufacturing activities in industry/ academia.

Director, Discovery

Position Summary

Genocea Biosciences, Inc. is a fast paced, innovative cancer vaccine and cell therapy company based on a unique screening technology (ATLAS™) enabling the identification of novel T cell antigens in samples originating from individuals suffering from cancer or other diseases. To date, this screening technology has delivered a number of completely novel antigens for various intractable infectious diseases and has enabled the initiation of a Phase 1/2a clinical trial to develop a personalized vaccine for solid tumors. The successful candidate for this position will be expected to lead the Discovery team and help broaden the application of the ATLAS™ technology to diverse new therapeutic areas and other immunological functions. The candidate will demonstrate deep mastery and up-to-date knowledge of T cell and innate immune cell biology, as well a detailed understanding and fluency in state-of-the-art high throughput cell-based assays. Extensive automation experience is also required. The candidate should have significant experience managing teams of associate and senior scientists as well as a keen ability to crystalize, communicate and implement strategy at all levels of the company. The ideal candidate should have 10+ years of experience in the pharmaceutical and/or biotechnology industry along with outstanding scientific credentials in the form of an extensive and relevant peer-reviewed publication track record. The candidate will also be an outstanding communicator, both in scientific and project-related strategy.

Primary Responsibilities

  • Leads team responsible for identification of neoantigens for personalized vaccine and cell therapy development

  • Plans and directs scientific projects aimed at miniaturizing and automating the high throughput identification of T cell antigens and T cell receptors. Identifies and manages necessary resources for achievement of goals.

  • Ensures that documentation of experimental data meets standards suitable to support publication, FDA submission and patent filing

  • Assists in the coordination and execution of research collaborations

  • Hires, manages, trains and mentors technical team consisting of junior and senior scientists. Establishes expectations, defines roles, supports career development and manages performance

  • Creates vision, delineates, communicates and implements technology development strategy for the entire company

  • Communicates with Executive team and peers to ensure that technological innovations are fully integrated in the organization

Competencies

  • Prior experience (5-10 years) working successfully in a management role. Demonstrated success in managing staff performance.  Ability to motivate staff to work effectively and hold staff accountable to individual and departmental goals

  • Documented topic-specific scientific expertise (peer-reviewed publications, invited speaking engagements)

Required Skills

  • Extensive experience in high-throughput cell-based assays, T cell biology, molecular biology, and automation. Knowledge of cell imaging and TCR sequencing preferred

  • Demonstrated skills in data analysis of complex multidimensional datasets, including laboratory and IT automation technologies

  • Excellent critical thinking, time management and organizational skills.

  • Excellent written and verbal communication skills, with the ability to present at the highest level.

  • Ability to engage, sustain and influence effective relationships at the management level.

Education Requirements

  • PhD in immunology, cell biology or related field

  • 10+ years relevant industrial experience

  • Background in immuno-oncology