Executive Assistant

Position Summary

Reporting to the Associate Director of Internal Operations, the Executive Assistant will be responsible for providing administrative support to the CMO, 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 G
  • 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)

 

Associate Director/Director, Quality Control

Position Summary

The Director of Quality Control will oversee the Quality testing efforts within the company maintaining compliance with FDA CFR parts 210 and 211, ICH Q series, and EU GMPs.  Processes will initially be focused on viral vector and nucleic acid based cancer vaccine products.   The Director of Quality Control supports the Gritstone drug product manufacturing process with the following responsibilities:

  • Develop, implement, and manage appropriate QC personnel and systems to support drug product manufacturing and release
  • Set up and manage a Quality Control Laboratory including equipment identification, method validation (ICH Q2 (R1)) and staffing
  • Develop and manage a QC equipment program including calibrations, qualifications, and equipment change control
  • Use of analytical methods for in process, final product and stability testing
  • Establish and manage a raw material testing program in collaboration with Development and Manufacturing groups
  • Establish and manage an Environmental Monitoring and Personnel Monitoring Program at Gritstone manufacturing facilities
  • Partner with the Analytical Development group to ensure successful transfer, qualification, and validation of analytical methods to QC
  • Establish and manage stability programs for intermediates, drug substances, and drug products
  • Prepare and technically review QC documentation such as Certificates of Analysis (COAs), specifications, analytical method procedures, qualification/validation protocols/reports
  • Provide oversight of outsourced QC activities at Contract Test Labs including review of supplier documents and COAs
  • Investigate Out of Specification(OOS) results and perform impact assessments and corrective actions in collaboration with Manufacturing and Quality Assurance

Minimum Education/Experience

  • BA/BS degree in technical discipline (e.g. Chemistry/Microbiology) required; advanced degree preferred
  • 10 years of experience in QC or analytical development in the biotechnology of pharmaceutical
  • 5 years of QC laboratory management
  • In-depth experience and working knowledge in biologics analytical test methodologies (vaccine therapy and plasmid analytical therapies preferred) and regulatory/pharmacopeia requirements for biologic testing
  • Experience in molecular biology and gene therapy/viral vector methods including qPCR, ELISA, virus titer assays, particle size assays, cell based potency assays
  • Experience with analytical test method qualification and validation
  • Experience with incoming raw material testing and release systems
  • Experience with clean room environmental monitoring and personnel monitoring programs

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)

 

Scientist/Senior Scientist, Analytical Development

Position Summary

The Scientist, Analytical Development will execute activities associated with the development, optimization and qualification/validation of analytical methods 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, production, engineering and process development to foster effective communication, technology transfer and achievement of corporate goals between groups. 

Summary of essential job functions

  • Actively contribute to successful development, qualification and execution of robust analytical methods in support of company pipeline projects
  • Manage activities at contract manufacturing organizations (CMO) and contract testing labs (CTL), including review and/or approval of test records/forms, protocols and reports, deviations/investigations, standard operating procedures (SOP) and certificates of analysis (COA)
  • Perform analytical procedures in support of characterization, lot release and stability testing of drug substance and drug products
  • Provide analytical support for IND-enabling process development and manufacturing operations, including qualification and tech transfer of in-process methods
  • Evaluate/select new technologies, instruments, reagents and perform necessary qualifications
  • Ensure high-quality and timely documentation in laboratory notebook and development reports
  • Draft and review SOPs, test records/forms, various analytical protocols and reports
  • Analyze/summarize experimental data and present findings to scientists and management at technical and project sub-team meetings
  • Work closely with Project Management, Regulatory Affairs and Quality to ensure project and regulatory filling timelines are met
  • Perform other duties as assigned, such as lab maintenance, technology evaluation, equipment purchase and qualifications, order and stock lab supplies, etc.

Minimum Education/Experience

The ideal candidate for this position will have demonstrated in-depth experience with hands-on execution and management of analytical development/QC function associated with the GMP production and testing of biologics in an industry setting. 

  • PhD or MS/BS in Biological Sciences or related scientific discipline, PhD preferred
  • 2+ years (PhD), or 4+ years (MS) Biotech/Pharmaceutical industry experience, with a primary focus on analytical development of biologics required
  • Experience in vaccine analytical method development and optimization desired
  • Experience in analytical method qualification, validation and technology transfer to QC lab desired
  • Knowledge of GMP and FDA/EMA/ICH/WHO/USP regulatory requirements desired
  • Good laboratory practice is a must
  • Must have hands-on experience in most analytical techniques for the analysis of DNA plasmid, RNA, and protein, such as sequencing, RE digestion, electrophoresis, PCR, qPCR, UV spectrometry, ELISA, Western blot, HPLC chromatography, Light scattering, etc, as well as experience in cell culture and virus-related analytical techniques.

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.
  • 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)
  • Experienced in using statistical and DOE software in analytical method development

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