Molecular Development Specialist

Molecular Development Specialist

The Molecular Development Specialist will lead the design, development, and clinical validation of laboratory-developed tests (LDTs) using molecular technologies (including NAATs and sequencing). This role requires strong analytical and problem-solving skills, familiarity with CLIA, NYSDOH (or equivalent) regulatory requirements and best practice guidelines, and experience preparing regulatory validation packages. The position is integral to advancing innovative diagnostic capabilities within the Molecular Diagnostics Laboratory. In addition to technical expertise, the molecular development specialist must possess strong interpersonal and communication skills to effectively train, mentor, and lead team members, fostering collaboration and ensuring knowledge transfer across the laboratory.

Responsibilities:

• Design, optimize, and validate new molecular diagnostic assays (NAATs, sequencing, etc.)
• Compile and submit validation packages to regulatory agencies (e.g., NYSDOH)
• Write and maintain SOPs, validation reports, and technical documentation
• Evaluate new molecular technologies and platforms for implementation
• Train and mentor laboratory staff in molecular techniques and assay workflows
• Support regulatory compliance and quality assurance in test development
• Contribute to abstracts, posters, and publications related to assay development

Thank you for your interest in Albany Medical Center! Albany Medical is an equal opportunity employer.

This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that:

Access to information is based on a "need to know" and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.