Specialist/Senior Specialist Quality Assurance Document Control

Position Summary:

This position is responsible for maintaining document control and document archive functions, and for facilitating processes for change control, training systems, vendor management, metrics reporting, and CAPA systems.   

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

  • Maintain a GMP compliant document control function facilitating appropriate processes, procedures, and practices. 

a.       Facilitate the process of creating, reviewing, approving and archiving standard operating procedures (SOPs), Batch Records, Work Instructions, etc. 

b.       Facilitate the system for the review, approval, and archiving of product specific CMO and internal manufacturing documentation. 

c.       Facilitate the system for the management of protocols, reports, and forms. 

d.       Ensure current versions of controlled GMP documents are readily available to site personnel.  

e.       Maintain the document control system in compliance with all applicable regulations.

  •  Maintain documents related to the corporate Training System and training records. 
  •  Maintain documents related to the corporate Quality Audit Program and track observations and coordinate responses with appropriate department managers
  • Maintain documents related to the corporate Deviation System and track deviation reports and CAPA actions for closure; assure that site managers are informed
  • Maintain documents related to the Change Control System
  • Create and maintain monthly QA metrics reports
  • QA system support during regulatory inspections with document retrieval function, inspection logistics oversight; other functions as required.  
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.

Requirements:

Minimum Education/Experience 

  • At least 2 years of experience in document management in a regulated industry.

Other Qualifications

  • 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.
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Strong written/verbal communication skills. 
  • Strong computer proficiency (MS Word, Excel, PowerPoint)

 

 

Manager, Warehouse and Supply Logistics

Position Summary:

The Manager of Warehouse and Supply Logistics is responsible for setting direction and providing management to the Pleasanton logistics & warehouse functions.  The Manager ensures all activities within span of control meet or exceed Gritstone Oncology’s standards and meet full compliance of all applicable regulatory governing (e.g., FDA, USDA, DEA, and DOT, etc.). In addition, this position is accountable for ensuring safe, cost-effective, and efficient warehouse and supply operations.  This individual will lead the coordination and communication locally between departments, across functions, and represent Gritstone Oncology regionally in all matters pertaining to transportation and warehousing.  

This position will establish and maintain procedures, plans and documentation associated with the logistics function.  

The Manager of Warehouse and Supply Logistics will monitor team performance and training; mentor, coach and develop departmental staff. 

Duties & Responsibilities:

  • Lead the Manufacturing site logistics function, defining and setting overall strategy and direction in full alignment and integration with local, US and global operating units.  Utilizes proven and develops new standards as required to achieve both strategic and operational success for the Company.
  • Develops, oversees and directs the implementation of departmental operations, strategies, policies and procedures in accordance with all applicable governing bodies including but not limited to FDA, USDA, DOT, CBP, OSHA, and in alignment with all Company policies, procedures, goals and objectives.
  • Directs all activities of the logistics and warehouse function to enable a compliant cGMP manufacturing site.  Implements and administers all systems and processes for maintaining control of 1) inventory and transaction accuracy, 2) warehouse and controlled temperature storage methods and facilities, and 3) domestic and international transportation programs, housekeeping, pest control and GMP compliance. 
  • Recruit, hire, train, coach and develop staff via effective performance and development planning. Manage the performance planning process for all direct reports, including yearly goal setting and performance reviews.
  • Assigns and manages resources, and organizes appropriate training to ensure staff members are able to properly perform their jobs and operate in a safe and compliant manner.
  • Writes and reviews reports, protocols and procedures upon request. Performs, documents and reviews change controls and investigations within their area of responsibility.
  • Manages projects and initiatives related to capacity utilization and optimization.  Leads process improvements to meet/exceed efficiency targets. 

Requirements:

  • High school diploma or equivalent.
  • Requires formal training in supply chain management, logistics, or closely related discipline.
  • Requires a minimum of ten (10) years’ experience that includes: in-depth understanding of cGMP Logistics operations, purchasing and inventory management in the Pharma/Biotech field.
  • Must possess a minimum of five (5) years supervisory or management experience.
  • Cold Chain experience required.
  • Strong knowledge of Quality System Process: CAPA, Deviations, Change Controls required.
  • Experience managing critical and complex projects required.
  • Must possess excellent attention to detail and analytical thinking.
  • Strong goal-setting, team leadership, mentoring and professional development skills required.
  • Strong ability to influence in a team environment and collaborate with peers is required.
  • Must have a working knowledge of Trade Compliance responsibilities, on both the import and export sides of the logistics business.
  • Must have excellent technical writing ability, oral and written communication skills.
  • Experience / ability to understand and develop procedures and other controlled documents required.
  • Strong knowledge and understanding of software packages and technologies used in a typical logistics operation, specifically Microsoft Office.
  • 3PL experience.
  • Working experience and knowledge of applicable regulatory requirements (FDA, FAA, IATA, DOT, Customs, and OSHA).
  • The ability to use a forklift and related warehouse equipment. 
  • Must be able to occasionally lift up to 50 lbs.
  • Must be able to push and pull up to 125 lbs.
  • Must be able to climb ladder and stairs.
  • Some domestic travel may be required.

Facilities Supervisor

Position Summary:

Reporting to the Facilities Engineer Director, the Facilities Supervisor is a hand-on position which will require a working knowledge in troubleshooting, repair and preventative maintenance procedures in relation to: CDA, VAC, HVAC, plumbing, PW and RODI systems in a cGMP manufacturing environment. The successful candidate will provide facility-related supervisory support and must have a strong understanding of cGMP manufacturing environment ideally in the vaccine manufacturing space.

Responsibilities:

  • Supervise the planning and implementation of facilities and utilities-oriented operational projects. Accountable for project management through the entire manufacturing facility work flow including scope, commissioning, validation, and closeout. Responsible for writing and reviewing operational and maintenance procedures.
  • Manage project costs, schedule and scope as they relate to quality, corporate goals and overall stakeholder requirements.
  • Execute the planning and project management of facility-related annual shutdowns.
  • Will manage teams consisting of internal staff, supervising and construction activities, and preparing turnover documentation.
  • Available to respond to emergency off hour calls as required.
  • Other duties as required.

Education and Qualifications:

  • High School Diploma or equivalent required.
  • An apprenticeship in the discipline of mechanical, electrical, plumbing, or related discipline is preferred.
  • 8+ years of pharmaceutical construction or maintenance management, and/or project management experience.
  • Knowledge requirements include biopharmaceutical and pharmaceutical process and facility design approaches, plus a solid understanding of cGMP requirements.
  • Must have strong understanding of MEP and utility systems as well as commissioning, qualification validation and maintenance activities.
  • Must have experience in conceptual development, design and implementation, planning, scheduling and project management of capital or maintenance projects.
  • Experience working to regulatory standards: FDA, Good Manufacturing Procedures (GMP), and Good Documentation Procedures (GDP).
  • Must have familiarity with MS Office and MS Project.
  • Must have strong organizational skills.
  • Must have excellent oral and written communication skills.
  • Must have a good team attitude.

Software Engineer

Position 

Gritstone Oncology is seeking a software engineer to join our team. Our analysis platform is integral to the construction of a unique vaccine for each patient and depends on the contributions of highly motivated and detail oriented individuals with a strong work ethic. 

Role

  • Develop and integrate software that advance our engineering and scientific goals.

  • Communicate and collaborate effectively with our team members, who include biologists, data scientists, engineers, and QA/regulatory managers. Make it your mission to support our key stakeholders.

  • Focus on building tools and methods that will improve automation and quality of core processes. 

Example technologies 

  • Python, Java/Groovy/JVM, MySQL and NoSQL DBs, HTTP APIs, Linux, git, Jenkins, Docker, AWS (EC2, S3, RDS, IAM), data analysis and visualization tools (Pandas, Jupyter, Tableau) 

Minimum Requirements 

  • Fluency in one or more general-purpose programming languages and related toolchains

  • Strong commitment to proper software engineering practices:

    • Requirements analysis and documentation

    • Software testing, verification, versioning and release

  • Good communication, collaboration, and interpersonal skills

  • BS degree in CS, Math, Physics, or other STEM discipline, plus 1-3 years of professional experience

  • Readiness to learn, apply and improve skills in a rapidly changing and technologically demanding environment 

Other Qualifications 

  • Experience with continuous integration and methods for automated build and test

  • Experience with AWS APIs and development in AWS ecosystem (e.g. IAM, EC2, Elastic Beanstalk, RDS, S3, CloudFormation)

  • Experience with web application development and frameworks (Spring, Django, Ruby on Rails, Grails)

Manufacturing Manager

Position Summary

Reporting to the Director of Manufacturing, the Manufacturing Manager will initially work closely with the Process Development department to assist and/or lead select process development efforts.  In parallel, the Manufacturing Manager will assist in start-up activities at a manufacturing plant being built.  Some support of management of Contract Manufacturing Organizations (CMOs), including serving as Person-In-Plant will be required.  The role will transition fully to a cGMP manufacturing role as the process matures. 

This role will need to liaise with research, development, and Quality Assurance to foster effective communication, technology transfer and achievement of corporate goals between groups.  This role will manage daily operations of cGMP manufacturing and include hiring of staff and development of cGMP procedures and policies.  Hands on and direct lab/cleanroom work is an expectation.

Summary of essential job functions

  • Possess experience and expertise in cGMP manufacturing environment
  • Possess experience and subject matter expertise in vector production –cell culture, purification, formulation, and fill
  • Experience in mRNA and Lipid Nanoparticle therapeutic vaccines a plus
  • Experience in supply chain management a plus
  • 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
  • Serve as Person-In-Plant at Contract Manufacturing Organization (CMO) when required
  • Author SOPs, batch records, and review Validation Reports
  • Author deviations, change controls, CAPAs, and reports; possess understanding of quality systems
  • Assist in drafting of facilities and process descriptions in regulatory filings (IND, BLA, etc…)
  • Support process development and optimization activities independently or with minimal guidance
  • Schedule production and coordinate/order/track/inventory raw material needs
  • Hire, lead, train, and mentor staff.

Minimum Education/Experience

  • B.S. / M.S. in Life Sciences, Chemical Engineering, or Biology
  • 10 years or more industry experience at pharmaceutical or biotechnology company
  • 8 years or more with M.S.
  • 6 years or more in a supervisory position
  • 5 years or more in a cGMP environment

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)
  • Up to 10% travel required, some international

Machine Learning Engineer / Scientist

Responsibilities

  • Develop software to integrate diverse data types (DNA/RNA sequencing, mass spectrometry, T cell data) to train machine learning models for neoantigen-targeted immunotherapy

  • Design and implement software testing procedures for machine learning models that will determine the composition of personalized therapeutics

  • Design and optimize neural network architectures specific to our applications in cancer immunology

Minimum Requirements

  • BS/MS or equivalent in computer science or another quantitative discipline (mathematics, physics, statistics, etc)

  • Proficiency with one or more general purpose programming languages (e.g., python, java, C++)

  • Expertise with at least one statistical programming language or toolset (e.g., R, python data science stack)

Preferred Qualifications

  • PhD in a quantitative discipline or comparable work experience

  • Experience with machine learning and machine learning software tools (e.g., scikit-learn), and in particular deep learning and deep learning software tools (e.g., Theano, Tensorflow, Keras, etc.)

  • Experience with data from at least one of the following relevant scientific domains: genomics, proteomics, immunology, oncology

 

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 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