Development Technologist


Job ID 18-00203

Industry Pharma

Job Type Permanent

Location Bridgewater, NJ

Description

Summary
Under the direction of the Principal Product Development Scientist, he/she will be part of the new Development team. This team supports the existing commercial test (Colvera TM) and also responsible for the improvement & development of current and new tests, respectively. He/she 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. 
 

Essential Responsibilities include but not limited to:
- Obtains training and understanding of all laboratory policies and procedures to fully comply with all laboratory CLIA, CAP, HIPAA, NY DOH and Quality System Manual requirements. 
- Competent to perform all tests in a high complexity testing commercial lab environment.
- Maintains 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. 
- Execute experiment in support of new product development including end-to-end assay performance, workflow and automation.
- Ensure all work adheres to established SOPs for programs, documentation, quality control, quality assurance, safety, specimen handling.
- Work in collaboration with existing team in clinical laboratory.
- Collaborate with the Research team in Australia to be aware of developing technologies/assays.
- Assist in performing validations of laboratory information system (LIS).
- Writing technical SOPs for procedures.
- Prepares and maintains detailed records of all experiment and results.  
- Assists in training of laboratory personnel on new procedures and/or equipment.
- Understands and follows all safety, infection control and OSHA Bloodborne Pathogen guidelines. 
- Attends all required in-services and relevant continuing education and staff department meetings
- Other duties as assigned.



Qualifications

Qualification Requirements
- Must meet CAP, NJDOH, and NYDOH requirements for High Complexity Testing with experience in Molecular Diagnostic testing in a clinical lab environment.
 

Education/Experience
- Bachelor's 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. 
- Eligible for Certification in Molecular Biology -MB(ASCP).
 

Skills/Knowledge/Cultural Fit
- Knowledge about real time PCR including practical experience 
- Assay troubleshooting and optimization (optional/preferable)
- 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 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 
- Must be flexible, innovative, and self-motivated