Executive Assistant

Position Summary

Reporting to the Associate Director of Internal Operations, the Executive Assistant will be responsible for providing administrative support to the Chief Medical Officer (CMO), Chief Financial Officer (CFO) and other management staff. Duties will include, but limited to, calendaring, travel arrangements and expense report submission. Candidate must project a professional company image through in-person and phone interactions.

Specific Responsibilities

  • Provide administrative support to the CMO, CFO and management team; e.g. travel (domestic and international), expense reporting, calendaring, meeting arrangements (internal and external)
  • Use tact, discretion, and good judgment in handling sensitive and confidential information
  • Sort and distribute incoming and outgoing mail
  • Greet visitors, ascertain nature of business, and direct visitors to appropriate person
  • Office supply management
  • Document creation and formatting (Word, Excel, PowerPoint)
  • Coordinate company-wide activities with Cambridge office
  • Assist in office-wide recruiting activities; manage resumes, schedule interviews, solicit feedback
  • Manage contract requests; work with legal group; Consulting Agreements, CDAs, MSAs, etc.
  • Assist with purchasing – vendor set-up and purchase order processing
  • Provide additional support as needed

Minimum Education/Experience

  • High school diploma with 5+ years of administrative experience required; Associates Degree preferred
  • Experience working with C-level executives required

Other Qualifications

  • 5+ years of administrative experience with proven track record of increasing responsibility and skill development
  • Demonstrated experience in supporting C-level executives in a fast-paced environment
  • Highly flexible team player with the ability to prioritize and work independently with limited supervision
  • Solid skills in managing office technology and confidential record keeping
  • Excellent communication and problem-solving skills, ability to work internationally
  • Desire to learn new skills and look for additional opportunities to contribute
  • Proactive approach to improving system efficiencies
  • Strong organizational skills and attention to detail
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)

 

Scientist II/Sr. Scientist, Product Development

Position Summary

Reporting to the Director of Process Development, the Product Development Scientist will work in the Process Development department to assist and/or lead select development efforts within the company to support 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. The PD scientist will play a key role in developing processes for cGMP manufacturing with an emphasis on QbD. This role will need to liaise with research, production, engineering and analytical technologies to foster effective communication, technology transfer and achievement of corporate goals between groups.  This role may need to manage daily operations of development laboratories and staff.  This position will also assist Director of Development and Engineering to estimate resource needs, develop budgets, manage facility needs and create timelines

Summary of essential job functions

  • Possess experience and working knowledge in adenoviral vectors –cell culture, adenovirus purification and formulation.
  • Possess experience and working knowledge in mRNA therapeutic vaccine candidate and formulation. Experience with lipid nanoparticle formulations is highly desirable.
  • Must be proficient in recombinant DNA technology methods like cloning, gel-electrophoresis, PCR, qPCR, ELISA, Northern and Southern Blotting.
  • Support process sampling plan to monitor process development activities and optimization through adequate sample archives
  • Perform/direct evaluation and selection efforts to identify candidate MCB and WCB
  • Assist in development efforts for process improvements toward closed-system, commercial compliant processes and reduced COGs
  • Coordinate development activities with analytical technologies to support product comparability and potential in-process control assay development
  • Generate publications on process improvements and technologies integration
  • Lead and coordinate staff career development efforts
  • Lead formulation development and cryopreservation and CRF candidate evaluations and optimizations
  • Integrate QbD guidelines into new processes
  • Assist in development related FMEA and RCA with engineering, as necessary
  • Assist in Tracking and Trending program structure and reporting
  • Participate in Gritstone’s multidisciplinary project teams to development activities
  • Coordinate and write as appropriate technical reports on key development findings
  • SME for technology transfer to CMOs and in-house GMP manufacturing
  • Support Regulatory Affairs to prepare, file and maintain appropriate regulatory body documents
  • Assist Project Management to determine development activities, timelines and resource needs to meet corporate goals
  • Assist in generation of timetables and budgets for development activities
  • As necessary, assist corporate development to support contracts and other legal documents to execute work plans and projects
  • As necessary, support Gritstone legal representatives to file and prosecute Gritstone intellectual property

Minimum Education/Experience

  •  Ph.D. in Life Sciences, Chemical, Mechanical or Bio-Engineering, or B.S. / M.S with equivalent experience
  •  8 years or more corporate experience at pharmaceutical or biotechnology company
  • 5 years or more corporate experience in team building and management
  • Experience in vaccine therapy and plasmid development and CMC regulatory knowledge required
  • Experience in regulatory requirements for combined products with vaccines desired
  • Experience in vaccine analytical methods filings desired

Other Qualifications

  • Strong organizational skills and attention to detail
  • Ability 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)
  • Proficiency using JMPÒ DOE and statistical software, or equivalent required
  • Up to 25% travel required, some international

 

Director / Sr. Director of Quality Assurance

Position Summary

The Director / Sr. Director of Quality Assurance will be responsible for the overall quality assurance for the company’s GxP activities. Develops, implements, prioritizes, and communicates the company’s GxP quality strategy and its GxP quality programs. Responsible for translating the company’s GxP quality strategy into tactical policies, processes, and procedures to meet global regulatory, medical/health and legislative standards.

Minimum Education/Experience

  • BA/BS degree in technical discipline (Chemistry/Microbiology/Engineering or similar) required; advanced degree preferred.
  • Minimum of 10-15 years’ relevant experience within the biotech or pharmaceutical industry.
  • Minimum of 5 years of experience in a leadership position with management experience required.
  • Candidate must have a proven track record working in a GxP compliant environment. Demonstrated ability to lead GxP operations. Applicant should also have experience in participating in internal audits and regulatory agency inspections.

Other Qualifications

  • Manage and implement GxP Quality systems including oversight and management of SOPs, Training and including oversight, management, and qualification of all vendors.
  • Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of API, Bulk drug product, packaged and labeled drug products to support clinical and commercial.
  • Collaborate and establish procedures with technical operations and manufacturing staff to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GCP/GMP requirements.
  • Direct the review and release of all products for which the sponsor holds the IND or equivalent investigational application.
  • Experience with biologic/vaccine API and DP processes in a contract manufacturing and testing environment.
  • Review and approve audit reports and Corrective and Preventive Actions (CAPAs)
  • Collaborate and resolve complex issues with regards to supplier performance. Assist in performing root cause analysis, risk assessments and identify appropriate corrective action plans. Effectively negotiate difficult conversations on a routine basis.
  • Oversees the technical review of data and documentation, ensuring that they are maintained in compliance with FDA regulations, global regulations and internal directives.
  • Develop and implement strategies for Supplier Quality Management, streamline processes and effectively utilize resources.
  • Perform or oversee internal and external audits ensuring compliance with company policies/procedures and applicable regulations.
  • Develop and train personnel for Inspection Readiness. Provide post-regulatory agency inspection support and follow-up as required.
  • Provide training, guidance and mentoring of staff with various experience levels and capabilities to develop new leaders, individual contributors, and technical experts.

Scientist/Senior Scientist, Mass Spectrometry and Proteomics

Position Summary

The Mass Spectrometry and Proteomics group at Gritstone Oncology is looking for a Scientist/Senior Scientist to help lead qualitative and quantitative mass spectrometry efforts in immunopeptidomics.  The primary role of the Scientist, Mass Spectrometry and Proteomics is to build and expand a large-scale tumor HLA peptide dataset using current methods and advance the methods to provide further biological characterization of the HLA presentation system in cancer.  This position works in a fast-paced collaborative environment with genome sequencing, bioinformatics, and machine learning colleagues. 

Minimum Education/Experience

  • PhD in Mass Spectrometry, Biochemistry or related field
  • 3+ years relevant experience – responsibility and title will be commensurate with experience level
  • Experience and expertise with Thermo Mass Spectrometers and data analysis systems
  • Experience and expertise in nanoflow HPLC
  • Working experience with immunoprecipitation sample preparation techniques

Other Qualifications

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, start-up company environment.
  • Self-motivated, self-disciplined, and able to function independently, as well as part of a team.
  • Strategic agility, strong critical thinking and problem solving
  • 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)