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How much do companion diagnostics jobs pay per hour?

As of Sep 15, 2026, the average hourly pay for companion diagnostics in the United States is $15.05, according to ZipRecruiter salary data. Most workers in this role earn between $13.94 and $15.62 per hour, depending on experience, location, and employer.

What is a companion diagnostic?

Companion diagnostics are laboratory tests or devices that provide information essential for the safe and effective use of a corresponding drug or biological product. They help determine whether a patient is likely to benefit from a particular therapy or if they may be at increased risk for serious side effects. These diagnostics are often used in personalized medicine, especially in cancer treatment, to tailor therapies to individual patients based on their genetic makeup or specific biomarkers.

How does a companion diagnostics professional typically collaborate with pharmaceutical and clinical teams during the drug development process?

Professionals in Companion Diagnostics work closely with pharmaceutical researchers and clinical trial teams to co-develop diagnostic tests that help identify patients most likely to benefit from specific therapies. This collaboration involves regular meetings to align on biomarker strategies, sharing clinical trial data, and ensuring that diagnostic assays meet regulatory requirements in tandem with the drug. It also includes troubleshooting assay performance and adapting protocols based on patient responses and trial outcomes. Effective communication and project management skills are essential, as timelines are often tight and priorities may shift quickly.

What are the key skills and qualifications needed to thrive as a companion diagnostics specialist, and why are they important?

To thrive as a Companion Diagnostics Specialist, you generally need a background in life sciences, molecular biology, or biomedical engineering, often supported by a relevant degree and experience in clinical diagnostics. Familiarity with laboratory technologies such as PCR, NGS platforms, and regulatory standards (e.g., FDA, CLIA) is typically required, and certifications in molecular diagnostics are advantageous. Strong analytical thinking, attention to detail, and effective communication with cross-functional teams make someone stand out in this role. These skills ensure accurate test development, regulatory compliance, and successful collaboration between diagnostic and therapeutic development teams, which are critical for patient-specific treatment strategies.

What is the difference between Companion Diagnostics vs Laboratory Technician?

AspectCompanion DiagnosticsLaboratory Technician
Required CredentialsTypically requires a degree in medical laboratory science, biology, or related field; certifications like ASCP are commonAssociate's or bachelor's degree in laboratory science or related field; certification may be required
Work EnvironmentPharmaceutical or biotech labs, hospitals, research facilitiesHospitals, diagnostic labs, research institutions
Industry UsageUsed in personalized medicine to guide treatment decisionsPerforms routine lab tests and sample processing

Companion Diagnostics specialists focus on developing tests that help tailor treatments to patients, requiring specialized knowledge and certifications. Laboratory Technicians perform routine lab work and support diagnostic processes. While both roles work in laboratory settings, their responsibilities and expertise levels differ significantly.

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What cities are hiring for Companion Diagnostics jobs?

Cities with the most Companion Diagnostics job openings:

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What are popular job titles for Companion Diagnostics?

Popular job titles for Companion Diagnostics:

Companion Diagnostics jobs near you
Infographic showing various Companion Diagnostics job openings in the United States as of September 2026, with employment types broken down into 4% Internship, 1% As Needed, 83% Full Time, 9% Part Time, 2% Contract, and 1% Nights. Highlights an 93% Physical, 1% Hybrid, and 6% Remote job distribution, with an average salary of $31,304 per year, or $15.1 per hour.

Senior Director, Companion Diagnostics

Frederick, MD • On-site

Precision Medicine Group
Pharmaceutical and Medicine Manufacturing • 1 - 5K employees
Learn more about Precision Medicine Groupexternal

Full-time

Re-posted 10 days ago

Job description

Position Summary:

The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx programs in development.  They will use their scientific expertise to lead design, development and validation efforts for cell therapy assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research. A critical requirement is deep current knowledge of FDA guidance documents and requirements, specifically relevant to companion diagnostics, along with the ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA. ISO 13485 and 15189 principles of design control, understanding of both CLIA and CLSI validation requirements, and assay execution of both cell-based and non-cell-based assays is required.

As the Senior Director, Companion Diagnostic, this person will train and mentor staff to ensure scientific rigor and regulatory compliance to GxP, CLSI, CLIA/CAP and State DOH (eg.,NY, CA, RI, PA) use their expertise to guide assay development and troubleshooting.  The position requires direct experience in all aspects of companion diagnostics, large molecule regulated bioanalysis and working knowledge of industry best practices. The person will work closely with QA and Regulatory to ensure regulatory compliance and work with project managers to ensure laboratory delivery and timely and efficient client communication. Lastly, the ideal candidate will have had experience with hosting and/ or participating in regulatory audits.

Essential functions of the job include but are not limited to:

  • Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
  • Works with Lab Director to identify and provide continuing education to laboratory testing personnel that is relevant to laboratory practices
  • Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects
  • Monitors and provides metrics, KPIs to senior leadership which includes but is not limited to: quality metrics, TAT, assay failure rate, volumes and revenue.
  • Monitors inventory (client and precision inventory) and lab supplies; ensures staff perform regular inventory counts and updates the inventory software system.
  • Ensure lab is run efficiently, reviews processes, SOPs and implements improvements regarding operational excellence.
  • Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provides verbal or written updates as necessary.
  • Participate actively in the companion diagnostics community to ensure Precision is fully aware of any and all relevant guidance with the Cell & Gene Therapy Industry
  • Participate in product (device) development, commercialization and life cycle management
  • Have good working knowledge of execution of assay according to ISO 13485 Design Control procedures, ISO 15189 Medical Laboratories as well as knowledge of CLIA and CLSI requirements for assay validation. Coordination of cross functional activities between Precision business units and among various subject matter experts to increase operational efficiencies and streamline deliverables to clients
  • Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements
  • Oversee the execution of all work to ensure the team understands and is meeting study compliance for all work performed, including study budget requirements.
  • Responsible for trouble shooting and correcting all scientific issues/problems within the team
  • Prepare/review/writes critical documents including protocols, reports, and SOPs
  • Work collaboratively with other technical teams in resource sharing and providing technical expertise
  • Maintain and support safe lab practices and environment
  • Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

  • PhD in Immunology or related field
  • 18+ years' relevant experience
  • 12+ years' leadership experience

Other Required:

  • Prior supervisory experience
  • Must have demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice
  • Direct experience and knowledge in cell based assays used for supporting regulated studies
  • A solid understanding of current GLP, GCP or GCLP standards
  • Working knowledge of CAP/CLIA, CLSI and ISO 13485
  • Excellent communication, interpersonal, organizational and multi-tasking skills
  • Must be proficient with Microsoft Word, Excel, and PowerPoint
  • Ability to interact and function in a highly productive work environment
  • Ability to work independently and have good attention to detail
  • Must be able to read, write, speak fluently and comprehend the English language

Preferred:

  • Direct experience working at a CRO, Biotechnology or Pharmaceutical company.
  • Expertise in ELISA, MSD, Luminex, Quanterix and SPR technologies

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