Medical Laboratory Scientist

AltPep Corporation is a biotechnology startup based along Seattle’s Lake Union focused on developing early disease-modifying treatments and detection tools for amyloid diseases by targeting one of the earliest molecular triggers – toxic soluble oligomers. These toxic oligomers are associated with many diseases, including neurodegenerative diseases and type 2 diabetes.

AltPep draws its origins to Dr. Valerie Daggett’s lab at the University of Washington’s (UW) Bioengineering Department. Since spinning out from the UW, the company has raised significant capital expanded its staff, and is currently seeking to expand at its headquarters located in a new state-of-the art facility on the Eastside Lake Union in Seattle.

We are looking for talented Medical Laboratory Scientist to join our team. As a Medical Laboratory Scientist, you will be instrumental in advancing our diagnostic capabilities, particularly focusing on ELISA-like technologies. This role requires a dynamic individual ready to engage both in research development and CLIA laboratory settings, ensuring the highest quality of our Laboratory Developed Tests (LDTs).

Key Responsibilities:

• Lead the development refinement of SOPs across all laboratory processes.
• Spreadhead the laboratory quality management system, fostering a culture of continuous improvement.
• Oversee validation and verification studies for advanced diagnostic methods.
• Uphold stringent laboratory procedures, ensuring compliance with regulatory standards.
• Drive quality control initiatives, maintain rigorous documentation and adherence to policies.
• Execute instrument maintenance, calibration, and qualification with meticulous attention to detail.
• Analyze Quality Indicators and apply data-driven insights to enhance laboratory operations.
• Resolve complex laboratory issues, optimizing test performance and operational efficiency.
• Maintain clear and proactive communications with the organization, escalating concerns to the CLIA Director as needed.
• Manage inventory ensuring the laboratory is well-stocked with essential supplies and reagents.
• Support the laboratory’s regulation obligations, contributing to certification and accreditation efforts.
• Participate actively in regulatory and compliance audits, demonstrating a thorough understanding of accreditation requirements.

Minimum Qualifications:

• Qualification meeting CLIA High-Complexity Testing Personnel requirements
• Bachelor's Degree with MT or equivalent certification (ASCP); or Fifty-week military Medical Laboratory Procedures course and meet qualifications for military enlisted occupational specialty of "Medical Laboratory Specialist"; Registered Medical Technologists (M.T.) by the American Society for Clinical Pathology (ASCP) or other recognized certification agency of medical laboratory professionals preferred.
• 3+ years clinical laboratory experience in a CLIA High Complexity Testing Laboratory
• Proven track record in managing CLIA-certification and Accreditation such as audits from accrediting bodies like the College of American Pathologists (CAP).
• Proficient with Medical Testing Site registration and CLIA certification requirements in Washington State, or more generally with CAP Accreditation.
• Proficient with Laboratory Information Management Systems (LIMS) and data visualization tools.
• Excellent verbal and written communication skills with demonstrated success in leading a team.

Preferred Qualifications:

• Advanced research experience, particularly in LDT development and validation.
• Proficiency in ELISA-based test methods and a robust understanding of structural biology and analytical chemistry.
• Expertise in immunochemistry assays and familiarity with automation equipment.

We offer competitive compensation for those joining our fight, The compensation range for a Medical Laboratory Scientist is $90,000-$110,000 and is dependent on experience.