You will work with the direction of the Product Development Manager, as an integral part of the new Development team in a fast-paced environment to develop and bring to marker molecular diagnostic tests for detection of circulating tumor DNA in blood.
This team supports the existing commercial test (Colvera TM) and is also responsible for the improvement & development of current and new tests, respectively.
You will be performing the experiments, analyzing data and reporting on the results. Essential to this role are relevant scientific training, commitment to quality, a strong work ethic, attention to detail and good documentation practices. The ideal candidate must have experience working in regulated environments such as CLIA and/or FDA.
Essential Responsibilities include but not limited to:
- Execute experiments in support of new product development including end-to-end assay performance, workflow and automation; process development, validation, and transfer to Operations.
- Work in collaboration with clinical laboratory team, operations, R&D team in Australia, other departments to develop/commercialize products.
- Responsible for receiving and labeling all goods in the laboratory.
- Work with the Lab Manager to maintain inventory of supplies, equipment and/or reagents and highlight the items that are running low.
- Ensures facilities and equipment are in optimal and proper working condition. Coordinates preventative maintenance and repairs as needed.
- Ensure all work adheres to established SOPs for programs, documentation, quality control, quality assurance, safety, specimen handling.
- Writing technical SOPs for procedures.
- Assists in training of laboratory personnel on new procedures and/or equipment.
- Obtains training and understanding of all laboratory policies and
procedures to fully comply with CLIA, HIPAA, Quality Management System, and
- Bachelors Degree in a biological or clinical laboratory science/ medical technology program by an accrediting institution with at least four years of pertinent research/development laboratory experience.
- Preferable: Master’s Degree or higher from an accredited institution with a major in biological sciences or medical technology with at least two years (Masters) of pertinent research/ development laboratory experience.
- Must meet CAP, NJDOH, and NYDOH requirements for High Complexity Testing with at least 1 year experience in Molecular Diagnostic testing in a clinical lab environment.
for Certification in Molecular Biology -MB(ASCP).
- Hands-on experience with molecular biology techniques such as nucleic acid extraction.
- Experience with handling human specimens and working knowledge of contamination control and prevention.
- Knowledge about real time PCR including practical experience (preferable).
- Assay troubleshooting and optimization (optional/preferable).
- Problem solving and analytical skills.
- Ability to work independently: exercise sound judgment and escalate issues when necessary.
- Strong oral and written skills.
- Ability to be highly productive and thrive in a high paced work environment.
- Highly detail oriented with effective time management, scheduling, and organizational skills.
- Ability to work within Quality systems under regulatory requirements.
- Good documentation practices.
- Must be flexible, innovative, and self-motivated.
Location: 1031 US Highway 202/206, Bridgewater, NJ 08807
Authorization: Unrestricted authorization to work in the US indefinitely.