Development Scientist

SkylineDx USA is seeking a Development Scientist to support process development and assay support activities for our CLIA‑certified laboratory. This role plays a key part in assay development, troubleshooting, technology transfer, and implementation of molecular diagnostic assays that translate clinically relevant discoveries into reliable tests that improve patient care.

As part of the Development team, the Development Scientist will collaborate closely with cross‑functional partners across R&D, the clinical laboratory, and quality teams. This position is based onsite at our San Diego, California office.

The ideal candidate will bring experience in clinical diagnostics, preferably in oncology, along with advanced hands‑on expertise in molecular techniques such as DNA and RNA extraction, PCR, microarray, and next‑generation sequencing (NGS). The successful candidate will be familiar with assay validation, laboratory automation, applied statistics, and regulated laboratory environments, and will demonstrate strong analytical skills, creative problem‑solving, and the ability to work independently in a fast‑paced setting.

DUTIES:

• Train and adhere to all relevant assay and laboratory Standard Operating Procedures (SOPs), policies, and protocols
• Maintain proficiency in current clinical assays and serve as a subject matter expert (SME) as needed
• Participate in clinical project teams and play an integral role in the transfer, validation, and launch of diagnostic assays into the SkylineDx USA CAP/CLIA laboratory
• Review, plan, set up, and execute experimental protocols to support development, validation, optimization, and troubleshooting of clinical assays
• Identify issues that may adversely affect assay performance or test result reporting and develop effective solutions
• Plan and implement process improvements to increase laboratory efficiency, scale operations, maintain regulatory compliance, and reduce cost of goods (COGS)
• Write, revise, and maintain laboratory procedures and technical documentation
• Provide training to laboratory staff on new assays and processes prior to and during assay transfer
• Collaborate with internal stakeholders to define and deliver study‑specific and project‑specific plans
• Assist in the preparation and review of validation documentation for new assays, methods, and procedures
• Provide support during quality audits and assist with vendor evaluation and selection as needed
• Ensure the privacy and confidentiality of personal and patient information in accordance with HIPAA guidelines
• Perform other responsibilities as assigned

EDUCATION/EXPERIENCE:

• PhD in Molecular Biology, Biological Sciences, or a related field
  • Candidates with an MS degree and equivalent relevant experience will also be considered
• Minimum of two years of post‑graduate experience in biotechnology, a post‑doctoral program, or a related field preferred
• Experience in clinical diagnostics, preferably within oncology
• Strong hands‑on expertise in molecular diagnostic techniques, including:
  • DNA and RNA extraction
  • PCR‑based methodologies
  • Microarray platforms
  • Next‑generation sequencing (NGS)
• Familiarity with molecular diagnostics, assay validation, laboratory automation, and regulated laboratory environments
• Working knowledge of applied statistics and experimental design
• Experience supporting or scaling operations in a clinical laboratory setting
• Strong analytical skills with a proactive, creative approach to problem‑solving
• Ability to work independently and thrive in a fast‑paced, collaborative, and growth‑oriented environment