Senior Scientist, Product Development


Job ID 18-00238

Industry Pharma

Job Type Permanent

Location Bridgewater, NJ

Description

Under direction of the Product Development Manager, you will work as an integral part of the new Development team in a fast-paced environment to develop and bring to market molecular diagnostic tests for detection of circulating tumor DNA in blood. You must have demonstrable technical proficiency, robust analytical thinking, collaboration in a cross-functional work environment, and the ability to work independently on complex issues. You will bring a strong understanding of the fundamentals of product development, optimization, scale-up, and commercialization of molecular diagnostic tests, as well as, technical support for existing products. Essential to this role are relevant scientific training and experience, a commitment to quality, a strong work ethic, attention to detail, ability to function independently, desire to move your team forward, and track record of success. The ideal candidate must have experience working in regulated environments such as CLIA and/or FDA.
Visit http://clinicalgenomics.com/ for more information.

Essential Responsibilities include but not limited to:
- Design and 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, other departments, corporate partners, and contract manufacturers to commercialize new products.
- Develop technical specifications, quality control test methods, and SOPs to support commercialization of new products.
- Collaborate with the Research team in Australia to be aware of developing technologies/assays.
- Ensures all work adheres to established policies and procedures, prepares and maintains detailed records of all experiment and results, and ensures protocols, reports, and appropriate documentation are written to required standards.
- Assists in training of personnel on new procedures and/or equipment.
- Obtains training and understanding of all laboratory policies and procedures to fully comply with all relevant laboratory CLIA, CAP, HIPAA, NY DOH, Quality Management System, and infection control and OSHA Bloodborne Pathogen
guidelines and requirements.
 



Qualifications

Education/Experience
- PhD in relevant scientific discipline (or equivalent) with at least 2 years experience in product development is preferred; or Master's Degree with a major in biological sciences or medical technology with at least 5 years of pertinent research and development experience.

Skills/Knowledge/Cultural Fit
- Knowledge about real time PCR including practical experience
- Assay troubleshooting and optimization
- Experience with statistical analysis and DOE (preferable)
- Strong 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 fast-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
- Experience with automated liquid handling for nucleic acid extraction and processing
- Experience planning, managing, and reporting experiments.