Product Development Associate
The Product Development Associate is involved in planning, conducting, and analyzing experiments leading to validation of diagnostic tests in the field of methylation-related oncology. The Product Development Associate works in a team and needs to communicate relevant information to professional colleagues and to participate constructively in decision making that will impact the performances of the final product). Responsible for compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO and state and federal requirements.
- Participate in the development and optimization of molecular assays in collaboration with others on assigned projects.
- Meets deadlines specified in overall project schedules.
- Elaborate detailed protocols to validate research hypothesis and confirm product compliance with predefined expected performances.
- Plan and execute simple experiments independently.
- May plan complex experiments independently.
- Perform lab work according to internal quality standards, document accurately the results and archive them accordingly in order to facilitate downstream work (intellectual property, regulatory affairs or research follow-ups).
- Maintain strict laboratory notebooks and research records.
- Analyze results using statistical methods, control for consistency with previous work, summarize and communicate main outcomes to team members.
- Participate in the evaluation and creation of new methods and procedures under the direction of a Product Development Scientist or VP, Product Development.
- Prepare technical reports, summaries, protocols and quantitative analyses that accurately and clearly communicate necessary information.
- Participate in the creation of all necessary documentation to support product manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.
- Apply professional concepts, in accordance with Company objectives to solve moderate to moderately complex problems in creative and effective ways.
- Maintain high level of professional expertise through familiarity with scientific literature.
- May participate in scientific conferences and contribute to scientific journals.
- Provides necessary training to Product Development team members and other personnel as required.
- May be responsible for identifying patentable inventions.
- Adapt to changes in processes, accepting approved changes and learning new tasks.
- Participate in continuing education programs (mandatory and non-mandatory).
- Knowledge of quality systems and quality systems regulations and ISO standards (ISO 13485 and ISO 9001-2008) a plus.
- Follow MDxHealth’s health and safety policies and procedures.
- Perform other related duties as required or assigned.
Education and Experience
- 2 to 5 years related work experience with Bachelor’s degree.
- 0 to 3 years related work experience with Master’s degree.
- 0 to 2 years related work experience with Ph.D. degree.
- Bachelor’s, Masters, or Ph.D. Degree in life science or equivalent scientific discipline.