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 market 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 developing, implementing and executing validation strategies for the regulatory approval of Class III Diagnostic assay. 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.
Essential Responsibilities include but not limited to:
Develop and implement validation strategy required for FDA approval of novel diagnostic assay; including both product and process requirements
Develop and implement analytical validation strategy required for regulatory approval
Support all clinical validation activities (as required)
Create verification and validation protocols, include the supporting statistical rationale, in support of product specifications and associated risk mitigation requirements
Develop and maintain verification and validation timelines – integrate into master project plan as required
Work closely with and support the Product Development and R&D departments to ensure corporate objectives and milestones are met
Coordinate multidisciplinary teams across multiple organizations and facilities to complete required product/process validations.
Prepare final reports and summaries as required to support regulatory submission
Maintain operation documents and records (production SOPs, component specifications, validation protocol and reports)
Provide routine updates to the project and executive management team
in internal or external training programs to maintain knowledge of validation
principles and industry trends.
- Bachelor’s degree (Master’s preferred) in a scientific or
technical discipline such as Chemical, Mechanical, Process Engineering,
Biomedical Engineering, or similar.
- 5-10 years experience in the medical device industry, preferably IVD in a development role with extensive validation experience.
- Experience with statistical analysis and DOE to be integrated into testing protocols.
- High-level technical writing skills and documentation experience including: protocol design, execution and reporting.
- Strong Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices and other international standards and regulations.
- Comprehensive knowledge of process development
Outstanding analytical and problem-solving skills
Fact-driven and Result oriented, Diligent, methodical
Highly detail oriented with effective time management, scheduling, and organizational skills
Excellent communication and stakeholder management skills
Very sound manufacturing knowledge
Experienced with design transfer, including packaging, labelling, and DMR writing
Excellent knowledge of Microsoft office suite including advanced knowledge in excel
Very good understanding of statistical methods and analysis.
Leadership experience of risk management activities (preferable)
Knowledge or familiarity with molecular biology is desirable.
Must be flexible, innovative, and self-motivated
to be highly productive and thrive in a high paced work environment.
Job Type: Full time
Location: 1031 US Highway 202/206, Bridgewater, NJ 08807
Authorization: Unrestricted authorization to work in the US indefinitely.