Careers

Immunexpress is a privately held company developing molecular diagnostic tools to aid clinicians in improving outcomes for suspected sepsis patients. Sepsis affects more than 1.6 million patients in the US every year and is the most expensive complication contributing to patient costs in US hospitals, totaling over $20 billion each year. Sepsis is difficult to diagnose, and there is an overwhelming clinical need for better diagnostic tools.

Immunexpress’s dynamic and innovative environment offers our employees the opportunity to advance and commercialize diagnostic tools to aid in differentiating infection from non-infectious causes of systemic inflammation, as well as early identification of the type of infection, in suspected sepsis patients. With FDA clearance of our first diagnostic, SeptiCyte™ LAB, we are expanding our operations and welcome dedicated and talented applicants to apply to join our growing team.

Please send resumes to [email protected]; include a cover letter that highlights your qualifications and matches our requirements. Immunexpress offers competitive salaries and an excellent benefits package to its employees.

Note: Immunexpress provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, we comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

 

Project Manager, Product Development
Seattle, WA, USA

 

Title

Project Manager

Purpose

  • To support the development of Immunexpress’s SeptiCyteTM molecular diagnostic technology on specific instrumentation (RT-qPCR)
  • To take full responsibility in managing both internal and external project activities and relationships associated with diagnostic assay development

Key Internal Relationships

Reports to Director, Product Development (Direct)
Senior Program Manager (Functional)

Qualifications

  • Advanced degree (MS/PhD) in Biochemistry, Molecular Biology, Biomedical Engineering, or related field

Experience, Understanding Of & Ability In

  • Managing projects related to medical diagnostic devices to strict budget, timelines and agreed deliverables (Class II / Class III)
  • Cross disciplinary experience in a commercial setting
  • Medical device manufacturing (GMP)
  • Leadership and/or management of contract research organizations (CROs)
  • Working within a quality management system (ISO13485 / FDA 21 CFR 820) with a sound knowledge of the design control process
  • US clinical trials and FDA regulatory submissions (GCP)
  • Practical lab proficiency in current molecular diagnostic technology. RT-qPCR knowledge, expertise and experience is highly desirable

Position Scope & Accountability

  • This role requires close interaction with Director Product Development, Senior Manager – Regulatory & Quality, Director Bioinformatics, and the Clinical Trials Manager
  • The role will require knowledge of project management disciplines including planning, scheduling, vendor management, risk assessment, budgeting, change management, and project control
  • Performance in this role will be judged on agreed deliverables to timelines and budget. Therefore, time management, planning skills and assertiveness are essential
  • The role requires close attention to technical detail, but also a high level of interpersonal skills for internal and external communications to realize deliverables
  • The role requires management of, and participation in, multiple concurrent fields of expertise – product development, regulatory and quality, and clinical affairs
  • The Project Manager will be expected to independently consult and/or contract (with permission) external resources to solve problems, and to meet project milestones and budget
  • The role will require some occasional travel to meet with development partners and sub-contractors

Desirable Traits & Skills

  • A team player who is eager to identify and solve problems, and who will promote cooperation in all functional areas
  • Excellent written and verbal communication, including listening skills, with an ability to distill information, and create order, structure and plans with and for a range of key stakeholders
  • Ability to motivate people, while at the same time, driving performance to strict timelines and budgets in an aggressive young company
  • Attention to detail, as well as the ability to see the ‘big picture’ and the role of the project within the company’s strategic direction
  • Able to work in an environment where sharing responsibility for success and failure is critical to overall success
Quality Assurance Specialist / Senior Quality Assurance Specialist
Seattle, WA, USA

 

Title

Quality Assurance Specialist

Purpose

To support the maintenance and implementation of the Immunexpress (IXP) Quality Management System (QMS) and all related activities at IXP.  Working closely with the Sr. Manager of Regulatory and Quality the successful candidate will assist product development activities related to quality requirements for in vitro diagnostic (IVD) products. Prepare and conduct internal audits and external audits of suppliers.  May include preparation of documentation for the FDA and other regulatory bodies.

Key Internal Relationships

Reports to Sr. Manager of Regulatory Affairs & Quality Assurance, works closely with all members of the technical and management team

Key Responsibilities

  • Provide Management with information on Quality Assurance requirements and needs
  • Assist in implementing ISO13485:2016
  • Maintain and administer QMS processes including document control, training, CAPA, and other Quality Records
  • Ensure supplier qualification through Supplier Controls
  • Conduct supplier (external) audits (requires some travel)
  • Manage internal audits
  • Conduct quality training, as needed
  • Ensure quality documentation of IXP’s product development and manufacturing
  • Write and revise SOPs
  • Travel to meet with sub-contractors and perform QMS audits
  • Be responsible for updating and curating the QMS documentation
  • Uphold IXP’s Quality Policy and ensure that activities related to product development and quality management meet applicable standards and regulations
  • Coordinate product design control activities
  • Compile quality metrics for presentation at Management Reviews
  • Preserve confidentiality of information

Qualifications

  • Bachelor’s degree in a health-related field – biomedical sciences is preferred

Experience, Understanding Of & Ability In

  • Working in a regulated environment especially GMP (3-5 years)
  • Experience relevant to in vitro diagnostics, preferably molecular diagnostics (ISO 13485 experience particularly relevant)
  • Managing and/or maintaining a QMS including performing various quality documentation procedures (e.g., document control administration, training file maintenance, DHF maintenance)
  • Working in start-up environments, small teams or industry experience (former preferred)
  • High attention to detail
  • Working independently and part of a team
  • Analyzing and summarizing complex information
  • Understanding basic molecular biology supporting IXP’s products
  • Proficiency with software used within the company (Mac OS X operating platform, Microsoft Word, PowerPoint, Excel)