Product Development Engineer II/III

Product Development Engineer II/III

Position Summary:

The Product Development Engineer will 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 Engineer will play a key role in designing processes and related equipment for cGMP manufacturing with an emphasis on QbD. The engineer will need to liaise with manufacturing to foster effective communication, enable technology transfer and trending manufacturing operations using statistical methods such as SPC, for continuous process improvement.

Summary of essential job functions

  • Possess experience and working knowledge in viral vectors – cell culture, purification and formulation

  • Must have experience in mammalian cell culture

  • Must have experience with Chromatography and TFF operations. Experience with Akta and Unicorn systems or other process control software is a plus.

  • Must be proficient in reading/creating P&ID for process equipment. Experience with CAD is desirable

  • Interact with vendors to design/scope and purchase equipment and assist in SAT/IOQ activities

  • Support process sampling plan to monitor process development activities and optimization through adequate sample archives

  • Assist in development efforts for process improvements toward closed-system, commercial compliant processes and reduced COGs

  • Integrate QbD guidelines into new processes. Experience with DoE is desirable.

  • Assist in development related FMEA and RCA with engineering, as necessary

  • Assist in Tracking and Trending program structure and reporting

  • Coordinate and write as appropriate technical reports on key development findings

  • SME for technology transfer to CMOs and in-house GMP manufacturing

  • Assists in troubleshooting process and equipment issues on the manufacturing floor. Must be willing and able to don clean room gowning to enter manufacturing areas

  • Support in creating SOPs and Batch records for new and existing processes

  • 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

Requirements:

Minimum Education/Experience

  • B.S. / M.S./Ph.D. in Chemical or Bio-Engineering

  • 2-5 years of corporate experience at pharmaceutical or biotechnology company

  • Experience in viral vectors or gene therapy is required

  • Experience in regulatory requirements for combined products with vaccines desired

  • Experience in GMP

 

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, Visio, PowerPoint)

  • Proficiency using JMPÒ DOE and statistical software, or equivalent required

  • Up to 25% travel required.

 

Research Associate I/II, Product Development

Research Associate I/II, Product Development

Position Summary:

The Product Development Research Associate will assist in development efforts within the company to support the design and development 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.  The incumbent may also work with CMOs for DNA synthesis, and needs to have a strong understanding of DNA synthesis and analysis.

Summary of essential job functions:

  • Assist Development scientists with process improvement projects for cell culture and purification development with analytical support:
    • Must have hands-on experience with running and maintaining HPLC systems.
    • Must have experience with UV-spectrometers and particle size analyzers.
    • Assist in cell culture development with immunostaining techniques.
    • Assist in virus purification development – must have experience in running gel electrophoresis. Virus or protein purification experience is desirable.
  • Experience with Plasmid manufacture and transfection:
    • Experience with Oligonucleotide synthesis and plasmid manufacture
    • Experience with bacterial transformation, plasmid amplification and transfection techniques.
    • Experience with DNA sequencing – NGS experience is a plus.

Requirements

Minimum Education/Experience

  • B.S. / M.S in Biochemistry or Molecular Biology with 3-5 years of experience
  • Experience with HPLC, UV spectrometry, particle size analysis.
  • Experience with immunoassays and gel electrophoresis is preferred
  • Experience with purification techniques like chromatography and filtration
  • Experience with robotic liquid handlers is desirable.
  • Experience working with plasmids and transfection is a plus.
  • Experience with cGMP regulations and requirements.

Other Qualifications

  • Strong organizational skills and attention to detail
  • Must have strong analytical thinking and ability to troubleshoot assay issues
  • 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 ability to prioritize, multi-task, and work in an evolving environment
  • Good written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)

 

Office Manager & Executive Assistant

Office Manager & Executive Assistant

Position Summary:

The Office Manager & Executive Assistant 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
  • Provide administrative support to the management team; e.g. travel (domestic and international), expense reporting, calendar, meeting arrangements (internal and external)
  • 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, site tour)
  • Fire Safety and Safety Committee Member, ensure OSHA compliance
  • 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
  • Minimum 3 years experience in a senior administrative role

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)

Scientist, Immunology

Scientist, Immunology

Position Summary:

Reporting to VP, Immunology, the Scientist will be responsible for designing, performing and analyzing experiments in the field of immunology. We are looking for an independent and flexible team player who will thrive in a high-paced dynamic environment.

 

Specific Responsibilities:

  • Design and perform assays to characterize T cell responses, including but not limited to TCR analysis, transcription analyses, flow cytometry and cell sorting

  • Cell culture, including primary human T cell cultures, development and maintenance of cell lines

  • Manage patient samples & maintain experimental records in electronic lab notebook

  • Assist with general laboratory duties including lab equipment maintenance, ordering and receiving of lab supplies

 

Essential Requirements

  • PhD in cellular immunology, at least 2 years post PhD experience in the field of immunology. Hands on expertise in methodologies, reagents and instrumentation used for culture and characterization of primary T lymphocytes.

  • High level of initiative, motivation and willingness to participate in a fast-paced work environment.

 

Preferred Qualifications

  • Extensive functional knowledge of cellular immunology is required

  • Experience with primary T cells and assays is required

  • Experience with human T cells is preferred

  • Functional knowledge of flow cytometry is required

  • Experience in cell sorting is a plus

  • Highly organized with excellent record keeping skills

  • Focus on delivery of stable, reliable solutions

  • Ability to prioritize and complete tasks and advance projects

  • Ability to interact adaptably with scientists and non-scientists from various disciplines

 

 

Research Associate / Senior Research Associate, NGS

Research Associate / Senior Research Associate, NGS

Position Summary:

The primary role of the research associate / senior research associate is to be responsible for the development and execution of next-generation sequencing (NGS)-based cancer genomics assays.

Minimum Education/Experience:

  • Bachelor’s or Master’s degree (or equivalent) in scientific discipline
  • 1-3 years relevant laboratory experience
  • Strong background in molecular biology or biochemistry and associated general laboratory techniques (PCR, qPCR, nucleic acid purification)
  • Familiarity with NGS workflows including nucleic acid extraction from various tissue specimens (cell line, blood, plasma, fresh frozen and FFPE), Illumina-based library construction, and hybrid capture enrichment
  • Operation and maintenance of instrumentation critical for Illumina NGS workflows (qPCR, plate readers and HiSeq/MiSeq sequencers)
  • The ability to analyze data and complete technical reports
  • 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
  • Experience with NGS workflow automation
  • LIMS experience
  • Histology experience (microtome operation, FFPE sectioning and H&E staining)

Senior Associate, Global Regulatory Affairs

Senior Associate, Global Regulatory Affairs

Position Summary:

The primary role of this position is to provide regulatory support for the development of Gritstone’s oncology therapeutics from submission of original INDs through early phase clinical trials to worldwide submission and approval.

Specific responsibilities include:

  • Assist in the authoring and facilitate the team review of Clinical, Nonclinical, and CMC documents for submission to Health Authorities (INDs, CTAs, amendments, annual reports, meeting packages, etc.)
  • Assist with the regulatory aspects of new investigator submissions, annual reports, protocol revisions, and pharmacovigilance-related submissions (e.g., PSURs/DSURs) as needed including preparation of cover letters and forms
  • Coordinate with publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with current health authority and industry submission standards
  • Assist with logging, tracking, and filing of correspondence with regulatory authorities
  • Help to ensure that all elements, quality, accuracy, and format of regulatory submissions and other documentation comply with applicable laws, regulations and standards
  • As assigned, perform literature searches, prepare special reports, and assemble documentation to support project teams
  • Maintain knowledge of global regulatory environment, regulations and guidelines
  • Participate in cross-functional subteams and working groups
  • Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures

Minimum Education/Experience

  • Bachelor degree (or equivalent) in life sciences, Masters preferred
  • 2+ years of experience in the pharmaceutical industry, direct experience in regulatory affairs or related function preferred

Other Qualifications

  • Fundamental understanding of GxP
  • Good understanding of clinical development of novel therapeutics, with a focus on the IND process
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing
  • 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
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems)
  • Experience with eCTD publishing systems

 

Director, Bioinformatics

Director, Bioinformatics

Position Summary:

Gritstone Oncology is seeking a Director, Bioinformatics to help harness the immune system to treat cancer. The Director will lead an expert team performing analyses of industry leading proprietary and public genomic and proteomic datasets to find actionable biological insights, including real-time neoantigen identification for patients.

 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:

  • Lead a team of experienced, creative bioinformaticians developing and performing novel, rigorous analyses in the research and clinical settings
  • Work closely with NGS, proteomics, and immunology lab scientists to design and interpret experiments
  • Manage implementation and application of informatics-related GMP quality systems
  • Coordinate high-volume, heterogeneous, complex data analysis under tight deadlines and stringent quality requirements
  • Ensure timely delivery of data to external partners and collaborators
  • Effectively manage team dynamics and stakeholders in a high-pressure, fast-paced environment
  • Willingness and ability to pitch in on method development and data analysis

Minimum Education/Experience:

  • Minimum 8 years experience in biotech/pharma industry, with 5+ years leading bioinformatics/computational biology teams
  • Small company experience preferred
  • PhD in Bioinformatics or a related highly quantitative field
  • 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, as evidenced for instance by key contributions to high-quality publications
  • Software engineering in python, including production-level code

 Desired Experience:

  • Applying in-depth knowledge of cancer biology
  • Analysis of large, publicly-available datasets (e.g. GTEx, TCGA, ExAC
  • Analysis of single cell data
  • Working on AWS

 

TM Operations Specialist II/III (Specimen Management)

TM Operations Specialist II/III (Specimen Management)

Position Summary:

The primary role of the Translational Medicine Operations (TM Ops) group at Gritstone Oncology is to provide clinical bio specimen management and logistics support to the various global oncology programs under clinical development. TM Ops reports into the Clinical Operations function at Gritstone Oncology.

The TM Ops Specialist II/III will have a background in biotech/pharma or research/healthcare, and will have some experience in matters related to biobanking and specimen acquisition.  This function will work closely with Research teams as well as Manufacturing and Quality Assurance (QA) personnel. Essential job functions include:  

  • Receive and log delivery of bio specimens daily.
  • Receive and log delivery of specimens intended for manufacturing use in accordance with GMP and company SOPs.
  • Inspect and verify contents of packages for specimen quality, appropriate shipping temperature and conditions, and data accuracy, communicate discrepancies to internal clinical operations, QA and manufacturing personnel and external clinical sites.
  • Document, track and resolve specimen related discrepancies.
  • Quarantine specimens intended for manufacturing use pending Quality inspection in accordance with company SOPs.
  • Assist with the set-up and implementation of the bio specimen storage system.
  • Enter/upload specimen related data into the appropriate specimen tracking and storage system.
  • May perform some basic specimen processing on request.
  • Retrieve clinical specimens from storage in accordance with relevant Research protocols, as requested by Research teams.
  • Assist Research teams with specimen storage management and maintenance. 
  • Route samples into the appropriate workflow(s) and ensure downstream laboratory staff is notified of specimen availability.
  • File specimen source documents, query resolutions, and other specimen related documentation in accordance with company policy.
  • Track specimen chain of custody in accordance with company SOPS.
  • Ship specimens to external hospitals/clinics or scientific collaborators per IATA regulations and guidelines. This includes generating specimen shipment manifests, providing shipment notifications and confirming specimen delivery.
  • Perform specimen data reconciliation and discrepancy resolution. Resolve specimen related issues with study sites and/or vendors.
  • Generate specimen management reports.  May analyze study/project level specimen management metrics and identify trends/issues for team discussion.
  • May assist with the review of clinical protocols, informed consent documents and Case Report Forms (CRFs) as it relates to specimen collection and logistics.
  • Perform a quality check on TM Ops authored documents (training slides, laboratory manuals, study aids, bio specimen management plans, etc.).  May provide input into the development of TM Ops documents.
  • Assist with management of TM Ops specimen vendors. Tasks may include: managing day to day vendor activities, managing vendor relationships, reviewing and negotiating vendor SOW/specifications/budgets for study setup, developing requests for proposals (RFPs), tracking vendor expenses against vendor contracts, and assisting in review of study invoices. 
  • Maintain the shared electronic departmental workspace. 
  • Follow established company SOPS for specimen handling, including GMP SOPs. 
  • Participate in departmental meetings.
  • Participate in special projects and/or assignments as requested by Manager/Director.

Requirements:

Minimum Education/Experience

  • BA/BS or equivalent degree in a scientific or healthcare related field.
  • 2+ years pharmaceutical/biotech industry experience.
  • IATA training certification a plus.
  • Some biobanking and/or specimen acquisition experience is preferred.
  • Prior experience in a clinical laboratory setting or other health related field is preferred.
  •  Experience working in a GMP regulated environment is a plus.

Other Qualifications

  • Strong organizational skills and attention to detail. 
  • Must be meticulous and thorough. 
  • Able to work effectively in a fast paced, small start-up company. 
  • Able to function independently as well as part of a team. 
  • Good written/verbal communication skills.
  • Excellent interpersonal skills. Customer-service oriented. 
  • Proficient in Microsoft Office.
  • Basic knowledge of GMP, GCP, ICH and general FDA guidelines. 
  • Familiarity with laboratory information management systems/web-based specimen management software. 
  • Familiarity with clinical study management systems (IVRx, EDC, etc.), preferred.
  • Familiarity with Good Documentation Practices (GDP) is a plus

Research Associate II, Analytical Development

Research Associate II, Analytical Development

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 Research associate, 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:

  • Under supervision of scientists, the candidate is expected to contribute to method development, optimization and qualification of various analytical methods and provide analytical service support
  • 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
  • Evaluate/select new technologies, instruments, reagents and perform necessary qualifications
  • Ensure high-quality and timely documentation in laboratory notebook and development reports
  • Draft SOPs, test records/forms, various analytical protocols and reports
  • Analyze/summarize experimental data and present findings at group meetings
  • Perform other duties as assigned, such as lab maintenance, technology evaluation, equipment purchases and qualifications, order and stock lab supplies, etc.

 Minimum Education/Experience

  • MS/BS in Biological Sciences or related scientific discipline
  • 2+ years (MS), or 4+ years (BS) Biotech/Pharmaceutical industry experience, with a primary focus on analytical development and services of biologics required  
  • Hands-on experience with cell culture and analytical techniques for viruses highly desired, experience working with Adenovirus is a plus
  • Experience in performing cell based potency assays desired
  • Experience in performing ELISA based immunoassays desired
  • Experience in performing RT-PCR, qPCR assays desired
  • Experience in performing analytical procedures for proteins (such as SDS-PAGE, silver stain, western blot, UV spectrometry, BCA/Lowry) desired
  • Experience working with HPLC desired
  • Experience in molecular biology techniques with plasmids desired
  • Good laboratory practice is a must
  • Understanding of and experience with 21CFR11 and ICHQ2 is a plus

Other Qualifications

  • Strong organizational skills and attention to detail
  • Ability to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, able to function in a collaborative team environment
  • 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 I/II, Analytical Development

Scientist I/II, Analytical Development

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 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:

  • The candidate is expected to 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, trouble-shooting and evaluating method performance during investigation of deviations
  • 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 purchases 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 developing and optimizing viral infectivity assay highly desirable, experience working with adenovirus is a plus 
  • Experience developing and optimizing cell-based potency assays highly desirable
  • Experience working with general vaccine analytical methods (such as CE, ELISA, qPCR, impurity assays) development and optimization desirable
  • Experience working with plasmids in a pharmaceutical setting desirable
  • Experience in analytical method qualification, validation and technology transfer to QC lab desirable
  • Knowledge of GMP and FDA/ /ICH/ /USP regulations,  as well as solid understanding of instrument/method validation (21CFR11 and ICHQ2) desirable
  • Good laboratory practice is a must

Other Qualifications

  • Strong planning/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.
  • 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