Senior Research Associate/Associate Scientist

Job Title: Senior Research Associate/Associate Scientist, Assay Development

Job Type: Full-Time

Position Overview: You will play a key role in the execution and optimization of IVD assays. You will be responsible for executing analytical verification protocols and ensuring the accuracy, reproducibility, and robustness of our assays. This role requires a hands-on scientist with a strong background in assay development, validation, and performance testing, particularly in the IVD field.

Key Responsibilities:

1. Execute analytical verification and validation protocols for IVD assays, ensuring compliance with regulatory standards (CLSI, FDA, ISO 13485).
2. Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Manufacturing, to support the development and commercialization of IVD assays.
3. Perform experiments to optimize assay conditions, troubleshoot technical issues, and ensure assay performance meets clinical and regulatory requirements.
4. Analyze and interpret experimental data, summarize findings, and document results in technical reports.
5. Assist in developing and maintaining Standard Operating Procedures (SOPs) and work instructions related to assay development and testing.
6. Ensure adherence to Good Laboratory Practices (GLP) and other quality and regulatory standards.
7. Maintain accurate laboratory records and ensure traceability of data.
8. Support the transfer of assays to manufacturing, including assisting with the preparation of technical documentation.

Required Qualifications:

1. Bachelor's degree in Molecular Biology, Biochemistry, Immunology, or a related field (Master's preferred).
2. 2+ years of experience in assay development, particularly for IVD products.
3. Hands-on experience executing analytical verification protocols, including accuracy, precision, linearity, and sensitivity studies.
4. Familiarity with CLSI guidelines and regulatory requirements for IVD assay verification.
5. Experience with performing verification protocols in support of regulatory body filings.
6. Strong data analysis skills and proficiency with statistical analysis tools (e.g., Excel, JMP, Minitab).
7. Ability to work independently and in a collaborative team environment.
8. Strong attention to detail and excellent documentation skills.

Preferred Qualifications:

1. Experience with immunoassays, molecular assays, or point-of-care (POC) diagnostic tests.
2. Knowledge of design control principles and experience working under ISO 13485 or other quality management systems.
3. Experience working in a regulated environment (FDA, CE Marking).

Benefits:

1. Competitive salary and benefits package.
2. Opportunity to work in a fast-paced, innovative environment.
3. Career growth and professional development opportunities.

This role is on-site and involves working in both office and laboratory settings. The employee may encounter hazardous chemicals, bloodborne pathogens, and automated equipment. While performing job responsibilities, the employee is regularly required to sit, reach with hands and arms, and communicate verbally. The role frequently involves standing and walking, and occasionally may require lifting or moving items up to 35 pounds.