Specialist/Sr.  Specialist or Manager/Sr. Manager, Quality Assurance Batch Release

Specialist/Sr. Specialist or Manager/Sr. Manager, Quality Assurance Batch Release

Position Summary:

The Specialist/Sr.  Specialist Quality Assurance Batch Release will partner with Manufacturing in the development and approval of Master Batch Records (MBR).  This position will also provide Quality reviews of and disposition of Executed Batch Records (EBR) and associated supporting documentation for the production of clinical products.  Additionally, this position will support any other GMP documentation reviews required for QA Batch Release.

The Specialist/Senior Specialist Quality Assurance Batch Release supports the drug product manufacturing process with the following responsibilities:

  • Responsible for the development/review/approval of MBRs

  • Responsible for the review and approval of EBRs

  • Work with internal manufacturing or CMOs as necessary to address any comments or corrections identified during the EBR review process

  • Confirm all deviations and investigation reports are closed prior to approval of EBRs

  • Collect and organize all required manufacturing documentation necessary for release of DS/DP

  • Maintain a batch record review schedule to ensure on-time product disposition

Additional responsibilities for the Manager/Sr. Manager Batch Release may include:

  • Manage CMO relationships with respect to Quality
  • Manage the Company Stability Program including Drug Substance, Drug Product for both internal and CMO manufacturing
  • Partner with QC on the review/approval of stability data
  • Review Stability protocols/reports as required

Minimum Education/Experience

  • Bachelor’s degree (or equivalent), preferably in scientific discipline or a health-related field and at least 2 years of experience reviewing Batch Documentation in the Pharmaceutical industry

  • Working knowledge of FDA and EMA GMP regulation and ICH guidance documents

  •  Experience in the manufacture of biopharmaceutical drug substance and drug products.

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)

 

Director/Senior Director, Vaccine Technologies

Director/Senior Director, Vaccine Technologies

Position Summary:

The Director/Senior Director of Vaccine Technologies will lead a molecular biology and virology team that develops cancer vaccines consisting of personalized tumor neo-epitope expression cassettes delivered by potentially various vaccine platforms such as self replicating RNA, viruses and plasmid.

Specific Responsibilities:

  • Recruitment and line management of lab scientists and technicians. 

  • Management and hands-on responsibility for vaccine development, including design and optimization of personalized multi-epitope expression cassette delivered by various vaccine platforms with strong focus on RNA based vaccines.

Requirements and Education:

  • PhD in Molecular Biology, Virology, or related field

  • Strong academic track record with >5 years in industry, 4+ in management

  • Significant track record of accomplishment as evidenced by launched products or core contributions to publications

Skills and Qualifications:

  • Excellent experience in developing self replicating RNA vaccines with expertise in molecular biology and virology techniques. Experience with Adenovirus, Lentivirus or plasmid vaccines preferred.

  • Strong management skills with managing a diverse group of scientists focusing on the development of various vaccine platforms

  • Excellent written and verbal communication skills
  • A good work ethic and willingness to participate in a fast-pace work environment are essential

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

 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, Cost Accounting

Associate Director, Cost Accounting

Position Summary:

The Associate Director, Cost Accounting position will play an integral role in the finance department, as well as provide cost and managerial accounting leadership to the entire Company.  The Cost Accounting function will work with, and support, both financial operations and general accounting to drive costing oversight and compliance.  The position will contribute to the development of the Manufacturing annual budget and subsequent reforecasts, cost rollups/inputs, and cost reduction plans.  In addition, the position will play an integral part in identifying areas of improvement and cost efficiency.  This position will perform special accounting projects as required.

 Key roles and responsibilities include: 

  • Lead the strategic direction of the cost accounting function, and act as a liaison between Manufacturing and the Finance Department, on all aspects of cost accounting.

  • Construct, maintain and update financial models for current and anticipated Manufacturing workflows and related costs.

  • Provide technical guidance, mentoring, and guidance, and ensure consistent application of cost accounting principles at our Manufacturing site, as well as external manufacturing vendors.

  • Act as key contributor to the Company’s annual planning and budgeting process for the Manufacturing group, including both expense and capital equipment requirements.  Provide budgeting and accounting direction to Manufacturing and related departments.

  • Develop new, robust processes to drive productivity in the cost accounting function.

  • Work with the Manufacturing operations group to identify cost saving opportunities, and continually analyze product cost inputs.

  • Ensure that proper controls and procedures are in place for the tracking and valuation of business assets and inventory. 

  • Lead monthly close process for cost accounting tasks, analyze manufacturing variances, review and approve journal entries and monthly balance sheet reconciliations.

  • Assist with the coordination and deliverables for quarterly reviews and annual audits performed by external auditors.

  • Prepare ad hoc analyses and assist team with research on cost accounting questions and assist with special projects as requested.

  • Assist in selection and implementation of ERP system.

 Minimum Education/Experience:

  • Bachelor’s degree in Business Administration with Accounting or Finance concentration; MBA preferable and/or CPA or CMA certification.

  • 7 – 10 years of direct experience in accounting, reporting and costing leadership within a medium to large operating company.

  • Cost accounting/manufacturing accounting background with in-depth knowledge of GAAP and financial reporting for a manufacturing organization.

Other Qualifications:

  •  Excellent judgement and creative problem-solving skills.

  • Strong knowledge of cost accounting principles including capitalization of variances and experience with rolling standard costs.

  • Ability to influence and engage business partners, peers, direct/indirect reports, and effectively interface with senior management.

  • Strong organizational and team building skills and proven ability to work with a diverse group of people.

  • Able to work effectively in a fast-paced, small start-up company environment, and adapt quickly to changing priorities.

  • Self-motivated, self-disciplined and able to function independently as well as part of a cohesive team.

  • Strong ability to prioritize, multi-task, and work in an evolving environment.

  • Excellent written and verbal communication skills.

  • Experience in using an ERP system.

  • Excellent computer proficiency (MS Word, Excel, Outlook).

 

 

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.

 

Bioinformatics Scientist (Proteomics)

Bioinformatics Scientist (Proteomics)

Position Summary:

Gritstone Oncology is seeking a Bioinformatics Scientist (Proteomics) to help harness the immune system to treat cancer. The Bioinformatics Scientist will perform analyses of industry leading proprietary and public proteomic and genomic datasets to discover novel targets for cancer immunotherapy and develop other 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:

  • Design and implementation of computational methods for high-throughput analysis of mass spectrometry (e.g., HLA peptide sequencing) data. Refine methodologies for data storage, processing and visualization, and optimize performance and usability.
  • Analyze both small and large-scale biological data, integrating proteomics and genomics
  • In collaboration with the broader team, develop and improve methods to extract maximal biological insight from both internal and external data sources.
  • Effectively communicate findings to stakeholders

 Requirements:

Minimum Education/Experience:

  • PhD in Bioinformatics, Computer Science, Biostatistics, or a related field.  Or MS plus 3+ years of comparable work experience.
  • Significant experience working with proteomics data in a scientific research environment.
  • Expertise in numerical data analysis and scientific programming.
  • Self-motivated and able to work independently or in a small team with minimal supervision. Excellent communication and organizational skills.

 Qualifications:

Desired Experience:

  • In depth understanding of mass spectrometry laboratory techniques
  • Applying in-depth knowledge of cancer biology
  • Fluency in python including numpy/scipy/pandas
  • Software engineering including writing production-level code
  • Working in the cloud or on a high-performance computing cluster