Bioinformatics Scientist (NGS)

Bioinformatics Scientist (NGS)

Position Summary

Gritstone Oncology is seeking a Bioinformatics Scientist to help harness the immune system to treat cancer.  The primary role of the Bioinformatics Scientist is to be responsible for analysis of next generation sequencing data and development and implementation of bioinformatics software tools to support research and development objectives at Gritstone Oncology

We are looking for an independent and flexible team player who will thrive in a fast-paced, dynamic, and highly collaborative environment. This is an opportunity to work for a well-funded early biotechnology company where bioinformatics analyses drive personalized cancer treatments.

Specific responsibilities:

  • Develop and perform novel, rigorous bioinformatics analyses
  • Work closely with other computational and experimental scientists to design experiments
  • Effectively communicate findings to stakeholders

 Minimum Education/Experience

  • PhD or Masters degree with comparable work experience, in bioinformatics, computational biology, or related scientific discipline
  • 3+ years relevant industry experience, including in a regulated setting

Other Qualifications

  • Proficiency with Python programming language
  • Experience with statistical analysis in R or Python, and data visualization are highly desireable
  • Experience with NGS software workflows and analysis of whole exome or targeted NGS sequencing data (DNA and RNA) on Illumina HiSeq/MiSeq sequencers
  • Knowledge of molecular biology, genetics, and cancer biology in addition to bioinformatics skills
  • Experience in execution of analysis SOPs to deliver the highest quality patient results in a regulated setting
  • CLIA/CAP or cGMP experience
  • Impeccable documentation practices and attention to detail
  • The ability to prioritize and complete tasks in a timely manner
  • Excellent written and verbal communication skills.
  • A willingness to work hard in a fast-paced environment

 

Scientist/Senior Scientist, In Vivo Tumor Immunology

Scientist/Senior Scientist, In Vivo Tumor Immunology

Position Summary:

Discover and develop new modalities for cancer immunotherapy through the design and application of robust in vitro assays and in vivo tumor efficacy models. Work within a fast-paced team to rapidly select lead immunotherapies.

Requirements:

Minimum Education/Experience

  • PhD in immunology, tumor biology or a related field with >5 years post-PhD experience and >2 years industry experience 
  • Strong background in T-cell immunology and/or oncology/tumor biology with hands-on skills in molecular and cellular biology, cell culture, flow cytometry, T-cell functional assays and murine tumor models.
  • Experience with immunodeficient, tumor xenograft, GEMM and/or PDX rodent models. 
  • A strong record of significant achievements in research and scientific creativity as evidenced by core contributions to publications.  
  • Project and CRO management experience a plus

Other Qualifications

  • Experience with the development and implementation of tumor models in both xenogeneic and syngeneic settings.
  • Highly agile individual with strong organizational and interpersonal skills, demonstrated ability to work in a highly collaborative and fast-paced environment with the ability to multi-task.
  • Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and coaching junior team members.
  • Intense “can do” startup mentality and motivation.
     

 

Office Manager

Office Manager

Position Summary:

The Office Manager will be responsible for the administrative and organizational management of Gritstone’s Pleasanton facility. The ideal candidate will be experienced in handling a wide range of administrative and office management related tasks. The candidate must be a highly motivated self-starter needing minimal supervision, and be able to anticipate and meet the operational needs of the office staff. 

  • Responsible for the day-to-day operations of the office
  • Oversee the office-related discretionary budget, and monitor and adjust spending accordingly 
  • Plan and execute team building activities
  • Office supply management
  • Manage the reception area and ensure effective telephone communications both internally and externally to maintain professional image
  • Greet visitors, ascertain nature of business, and direct visitors to appropriate person
  • Document creation and formatting (Word, Excel, PowerPoint)
  • Coordinate company-wide activities with Emeryville and Cambridge offices
  • Conduct new hire orientation (I9 documentation)
  • Fire Safety and Safety Committee Member, ensure OSHA compliance
  • Provide administrative support to the management team; e.g. travel (domestic and international), expense reporting, calendar, meeting arrangements (internal and external)
  • Manage contract requests; liaison to legal counsel; Consulting Agreements, CDAs, MSAs, etc.
  • Assist with purchasing – vendor set-up and purchase order processing
  • Provide additional support as needed

Requirements:

Minimum Education/Experience

  • Bachelor’s degree or equivalent preferred
  • Minimum 2 years office management or operations experience, preferably in a GMP or biotech environment

Other Qualifications

  • Reliable team player with a leadership mentality that can ‘make things happen’
  • Ability to handle sensitive and confidential information with discretion
  • Highly detail oriented with strong project management, organizational and relationship building skills
  • Ability to prioritize, multi-task and work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Excellent written and verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)
     

 

Bioinformatics Scientist

Bioinformatics Scientist

Position Summary:

Gritstone Oncology is seeking a Bioinformatics Scientist to help harness the immune system to treat cancer. The Bioinformatics Scientist will perform analyses of industry leading proprietary and public genomic and proteomic datasets to find actionable biological insights.  

We are looking for an independent and flexible team player who will thrive in a fast-paced, dynamic, and highly collaborative environment. This is an opportunity to work for a well-funded early biotechnology company where bioinformatics analyses drive personalized cancer treatments.

Specific Responsibilities

  • Develop and perform novel, rigorous bioinformatics analyses
  • Work closely with other computational and experimental scientists to design experiments
  • Effectively communicate findings to stakeholders

Requirements:

Minimum Education/Experience

  • PhD in Bioinformatics or a related field or comparable work experience
  • Training and experience in applying rigorous statistical methods for hypothesis testing to biological data
  • Track record of success in analyzing Mass Spectrometry or NGS data

Desired Experience

  • Applying in-depth knowledge of cancer biology
  • Analysis of large, publicly-available datasets (e.g. GTEx, TCGA, ExAC)
  • Coding in python including Pandas
  • Software engineering including writing production-level code
  • Analysis of single cell data
  • Working in the cloud or on a high-performance computing cluster 

 

Associate Director, Legal Operations

Associate Director, Legal Operations

Position Summary:

The Associate Director, Legal Operations will be responsible for the operational development, optimization, implementation, and management of Legal Department IT and manual systems and processes, including the contract management system, Legal Department SharePoint page, contract templates, electronic signature system, and the overall contracting process.  

This role will also include drafting, processing and support for the lifecycle of various agreement types, such as NDAs, service and consulting agreements, license agreements, contract manufacturing and research organization agreements, collaboration agreements, clinical trial agreements, material transfer agreements, research agreements, and others.  
In addition, the person in this position will provide assistance with substantive legal transactions involving intellectual property, financing and other areas.  Policy and procedure drafting and preparation of training is also anticipated.  This position works closely with the Associate General Counsel and Chief Business Officer, and will have extensive interaction with all internal functions.

Requirements:

Minimum Education/Experience

  • Bachelor’s degree (or equivalent).
  • 5-7+ years relevant industry experience in an in-house Legal Department (preferably in Biotech/Pharma).  Experience in a law firm handling high volumes of transactions a plus.
  • Experience with implementation and administration of SharePoint, contract management, electronic signature and other legal IT systems.
  • Experience managing IT vendors for Legal Department systems.
  • Working Knowledge of various types of contract templates and process of contract negotiation. Fluency with basic contract terms common to all contracts
  • Experience with Biotech manufacturing, R&D, clinical and preclinical transactions domestically and abroad a plus. 

Other Qualifications

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)
  • Professional and courteous demeanor

Associate Director/Director, Information Technology

Associate Director/Director, Information Technology

Position Summary:

The IT Director will lead the design, implementation, and growth of our information technology infrastructure. This individual will manage infrastructure and resources to meet organizational needs and will be responsible for working cross-­functionally with all departments to identify long term, scalable, practical solutions for research and operations as the organization grows. The successful candidate will be expected to travel between Company sites and establish close partnerships with colleagues from multiple locations to translate business needs into state of the art informatics solutions.

Role & Responsibilities:

 Infrastructure strategy, operation, innovation, resourcing, and organization

  • Oversee corporate IT infrastructure for networking, file storage, and communication (including overall configuration, security, upgrades, maintenance, backups, business continuity and disaster recovery). 
  • Actively monitor infrastructure for performance, security risks and threat awareness.
  • Manage lifecycle of all corporate IT resources: evaluation, acquisition, deployment, maintenance, and support of equipment including servers, PCs, Macs, lab equipment, telephones and VTC equipment, software applications.
  • Establish and exercise backup, restore and disaster recovery procedures.
  • Assess emerging business needs and facilitate growth and innovation through evaluation of new technology and/or pilot projects. 
  • Manage IT staff and contractors at all Gritstone sites.
  • Negotiate and administer vendor and consultant contracts and service agreements.
  • Oversee help desk for end users and ensure rapid response for mission-critical workstreams.
  • Promote company-wide IT capabilities and ensure awareness of policies through training and user documentation.
  • Ability to drive IT strategy and implementation in a fast-paced, growing company, with a focus on security and reliability.
  • Oversee development and evolution of technology roadmap.
  • Establish policies, standards, practices, and security measures to ensure effective and consistent information processing operations and information security.
  • IT strategic planning aligned with company goals and compliance standards.
  • Partner with business and IT stakeholders to promote effective use of enterprise systems across the organization.
  • Oversee programs for IT asset acquisitions and modifications to IT and automation systems including adherence to change control requirements.

 Regulatory compliance and validation

  • Support the validation and testing of IT infrastructure used in regulated/cGMP environment. 
  • Coordinate with Scientific, QA and Engineering stakeholders to establish effective IT and security policies for both regulated and research systems, and implement these policies and procedures with a documented and systematic approach.

Requirements:

Minimum Education/Experience

  • Advanced degree in Information Technology or computer science related field.
  • Knowledge of FDA compliance requirements, including software validation and GAMP. Experience in the pharmaceutical, biotech or diagnostic industries.
  • Experience with IAAS/PAAS/SAAS solutions.
  • VCP, AWS, ISC/CISSP, PMP, ITIL Certifications.
  • 10+ years of experience in IT, with demonstrated technical and professional development and a proven ability to design, deliver and support enterprise-grade IT solutions.
  • 5+ years leading IT teams and providing technology leadership.
  • Strong and demonstrable expertise in IT architecture and modern approaches for VLAN/WLAN networking, server virtualization, information security and user authentication, data storage, and cloud-based services.
  • Hands-on knowledge of common business and collaboration applications (SharePoint, Office365, Adobe).
  • Hands-on experience supporting heterogeneous networks of PCs, Macs, VTC and embedded devices, lab equipment.
  • Familiarity with high performance storage and computing architecture.
  • Hands-on experience with cloud providers (such as AWS, Azure) and enterprise server virtualization.

Other Qualifications

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment.
  • Self-motivated, self-disciplined and able to function independently as well as part of a team.
  • Strategic agility, strong critical and logical thinking with ability to analyze problems.
  • Strong ability to prioritize, multi-task, and work in an evolving environment.
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)
  • Ability to travel between sites one week per month

Senior Manager/Associate Director, Regulatory Affairs CMC

Senior Manager/Associate Director, Regulatory Affairs CMC

Position Summary:

The primary role of this position is to provide regulatory CMC advice and direction, including the interpretation and application of global CMC regulations and guidance, to facilitate the development of products from early phase clinical trials through to worldwide submission and approval.

Specific responsibilities include:

  • Participation in or leadership of cross-functional subteams, development of regulatory strategies, and support for oncology development programs
  • Preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, meeting packages, etc.), to ensure timelines are met
  • Preparation of technical assessments of CMC source documentation and responses to technical questions on document content
  • Initiation and and/or contribution to local process improvements which have an impact on Regulatory Affairs or other departments
  • Involvement in preparation for and support of CMC interactions with regulatory health authorities

Requirements:

Minimum Education/Experience

  • Bachelor’s or Master’s degree (or equivalent) in life sciences
  • 5+ years of experience in regulatory affairs or related function within a biotechnology company
  • Direct experience managing regulatory CMC aspects of investigational biologic products essential, prefer experience with both mammalian and bacterial-derived products including vaccines, gene or cell therapy products


Qualifications

  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with all levels of management and contract manufacturing organizations
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
  • Strong knowledge of cGMP for biologic products, understanding of biopharmaceutical development, and CMC regulatory affairs
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze and propose solutions to problems
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems)

 

Senior Scientist, Antibody Discovery and Engineering

Senior Scientist, Antibody Discovery and Engineering

Position Summary:

The Senior Scientist will be supporting preclinical projects related to antibody discovery and development, and will perform antibody design, engineering, production, and biochemical/biophysical characterization, and will establish in vitro (cell-based) assays for the evaluation of cancer immunotherapies.

Requirements:

Minimum Education/Experience

  • PhD in Molecular Biology, Immunology, or a related field with ≥4 years post-PhD experience, including industry experience. 
  • Strong background in molecular biology, immunology and/or oncology with experience in antibody drug discovery, development and/or antibody engineering for the development of immunotherapeutics.
  • A strong record of significant achievements in research and scientific creativity as evidenced by core contributions to publications.
  • Project and CRO management experience is highly desirable.
     

Qualifications

  • Demonstrated experience in the design and evaluation of biotherapeutics from discovery to lead optimization.
  • Technical expertise with characterization of engineered proteins through biophysical assays and in vitro cell based assays.
  • Highly agile with strong organizational and interpersonal skills, demonstrated ability to work in a fast pace, highly collaborative environment with ability to multi-task.
  • Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and coaching junior team members.
  • Intense “can do” startup mentality and motivation.

 

Manufacturing Associate I/II

Manufacturing Associate I/II

Position Summary:

Gritstone Oncology is a cancer immunotherapy company developing next-generation personalized cancer therapeutics. The company’s initial goal is to identify and deploy therapeutic neo-antigens from individual patients’ tumors to develop novel treatments for lung cancer.

The Manufacturing Associate will execute activities associated with manufacturing, as well as, development, optimization and qualification/validation in support of all Gritstone drug product manufacturing processes. Processes will vary in substance and composition, but will initially be focused on viral vector and nucleic acid based cancer vaccine products. This role will need to liaise with research, process development and Quality Assurance to foster effective communication, technology transfer and achievement of corporate goals between groups. 

Summary of Essential Job Functions: 

  • Responsible for day to day manufacturing activities including stocking of materials, preparation of documentation, cleaning and sanitization of rooms and equipment, operation of process equipment
  • Stock production area with supplies
  • Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day
  • Execute process steps according to defined SOPs and batch records
  • Document activities in accordance with cGMPs
  • Follow accurate verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation
  • Maintain cleanliness and orderliness of operational area
  • Actively contribute to successful development, qualification and execution of robust manufacturing processes in support of company pipeline projects
  • Identify process and quality problems and follow corrective actions
  • Demonstrate knowledge and understanding of GMPs and how they apply to specific responsibilities
  • Maintain a safe working environment
  • Follow company policies and procedures

Requirements:

The successful candidate for this position will have demonstrated in-depth experience with GMP production. In addition, the candidate should have the following education/experience;

  • BS in Biological Sciences or related scientific discipline
  • 0 - 2 years or more in a cGMP manufacturing environment
  • Knowledge of GMP and regulatory requirements preferred

Other Qualifications:

  • Ability to lift items up to 35 lbs
  • Manual dexterity
  • Strong organizational skills and attention to detail, able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strong critical and logical thinking with ability to analyze problems
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)