Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.  Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.  In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development Team is seeking a highly motivated Senior-level Reagent Manufacturing Process Engineer to lead and perform development of manufacturing workflows and reagent kit design of NGS sample preparation reagents for internal and external use. At Guardant, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful and meaningful technologies for cancer management.

As a Sr. Manufacturing Process Engineer-Reagents you will work with members in the team and collaborate cross-functionally with members of technology development, assay, bioinformatics, automation, clinical development, supply chain, and manufacoperations. You will provide technical leadership to departments and functions for reagent product development and related packaging, including the following: primary product containers (bottles, bags, tubes, other); boxes (kit boxes, corrugated inserts, other); labels (primary container labels; kit labels, in-process labels, other); and plate sealing methods. You will lead and participate in teams supporting IVD and LDT products throughout the development life-cycle, working under design control in accordance with applicable regulatory requirements (FDA, ISO13485). We require a candidate with in-depth knowledge and experience in the areas of manufacturing process development, scale-up, optimization, and troubleshooting.

Responsibilities

Reagent Manufacturing Workflow Process design and development:

• Work with a technical reagent development scientists, process and automation engineers to design, develop and implement manufacturing processes for new reagents.
• Participate in process and engineering functions as needed and related to new product introductions, process improvements, new equipment integration, automation initiatives, scale up, process validations, and packaging design.
• Gather system requirements and synthesize these into design solutions
• Coordinate with Supply Chain and Quality Assurance management to establish new parts, maintain Bill of Materials, and manage purchasing specifications for vendors/contract organizations.

 Packaging design and development:

• Planning and execution of laboratory studies to support packaging design for shipping temperature-sensitive reagent kits to external sites
• Working with systems engineers to document packaging requirements, specifications, verification, and technology transfer to operations
• Provide technical support for production packaging/labeling tools and software including assembly/sealing equipment and automation site-wide
• Reagent label design, development, and technology transfer to operations
• Work with Quality Assurance, Regulatory, and Supply Chain departments for domestic and international requirements (e.g. labeling, customs, etc.) for distribution.

Tech Transfer and Product life-cycle management:

• Collaborate cross-functionally to facilitate the effective transfer of manufacturing processes to a Manufacturing Operations Group.
• Identify, investigate, and resolve process related issues within a change controlled environment
• Ensure all work is performed and documented in compliance with applicable regulatory and quality standards (FDA, ISO13485)
• Present data, proposals, and progress at group and core team meetings
• Mentor and train team members, internal collaborators and stakeholders

• Minimum Bachelor of Science degree in Mechanical, Chemical, or Biomedical, or Manufacturing Engineering with 5+ years applicable experience in process engineering within a regulated environment.
• Demonstrated application of cGMP, ISO13485, and other QSR regulations for reagent manufacturing processes, using both manual and automated lab equipment or fluid handling systems
• Demonstrated experience documenting process workflows, requirements, specifications, protocols and work instructions to build reagent kits for molecular biology assays within a regulated environment of change control.
• Experience in the application of production and process controls including process validation, test method validation, process control plans, statistical process control, risk management and statistical tools
• Knowledge and experience with reagent labeling, packaging, assembly and manufacturing methods/equipment for domestic and international distribution.
• Experience creating reagent label specifications, deploying labels into operations under design control, using enterprise barcode label management software (Bartender or equivalent)
• Experience creating Instrument IQ/OQ and defining acceptance criteria for new equipment
• Demonstrated ability to drive, collaborate, and contribute to projects and timelines across multiple functions within a fast-paced environment

Employee may be required to lift routine office supplies and use office equipment.  Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.  Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

#preventivemedicine #team #cancer #clinicaltrial #cancertreatment #hematology #cancertherapy #NGS  #GuardantHealth #PatientFirst #LiquidBiopsy #LUNAR #Eclipse #RealWorldEvidence #CDx  #CompanionDiagnostics #biojobs #biotechjobs #biotechcareers #biocareers #pharmajobs #oncologyjobs #biotechbay #LI-CM1