FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading product development processes, particularly in molecular diagnostics and qPCR assay development, while ensuring compliance with FDA and ISO standards. Proficient in process validation, contamination control, and mentoring team members to drive continuous improvement in manufacturing practices.
Highest-signal resume keywords
Molecular Diagnostics/qPCR Assay DevelopmentCGMP ComplianceProcess Validation and ImprovementProject ManagementFDA/ISO Quality Standards
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
QPCR OptimizationAssay Design SpecificationsContamination Control WorkflowsData Analysis TemplatesMaterial TransactionsLean ManufacturingRoot-Cause AnalysisDesign ControlsGood Documentation PracticesProcess Verification
Soft Skills
MentoringTrainingCollaborationProblem-SolvingCommunication
Tools & Technologies
Bio-Rad CFXQuantStudioLightCyclerExcel
Industry Keywords
IVDRUOMolecular BiologyBioengineeringChemical EngineeringBiochemical EngineeringBiochemistryImmunoassayCLSI GuidelinesContinuous Improvement
About the role
Key responsibilities & impact- Lead New Product Introduction design transfer from Assay Development to Manufacturing
- Complete Product Development Process requirements
- Partner with Assay and Process Development to define assay requirements and design specifications
- Set specifications and acceptance criteria for raw materials and in-process materials
- Characterize and optimize qPCR performance and reduce variability
- Establish contamination-control workflows for nucleic-acid reagent manufacturing
- Translate assay designs into manufacturing and in-process test instructions
- Build reagents at scale for feasibility and design verification, completing batch records per cGMP
- Plan and execute process verification using functional qPCR testing against reference lots
- Complete material transactions for accurate inventory control
- Mentor and train junior team members
- Drive lean manufacturing and process improvements
- Lead investigations and root-cause analysis to resolve product and process issues
- Develop electronic work instructions and data analysis templates
- Review batch records and partner with QA on deviations, NCMRs, CAPAs, and change control
- Ensure documentation complies with FDA and ISO standards and support regulatory submissions, audits, and inspections
Requirements
What you’ll need- Master’s degree with 3–5 years of industry experience, or Ph.D. with 1+ years of industry experience in Molecular Biology, Bioengineering, Chemical or Biochemical Engineering, Chemistry, Biochemistry, or a related field
- Experience in molecular diagnostics/qPCR assay development and transfer of IVD/RUO assays in a regulated industry
- Hands-on qPCR or molecular diagnostic assay development, optimization, and troubleshooting
- Experience with real-time PCR instruments and software such as Bio-Rad CFX, QuantStudio, or LightCycler
- Knowledge of nucleic-acid reagent quality and stability, including oligo QC, enzyme/master mix lot qualification, and contamination control
- Experience with product/technology transfer and IVD or RUO molecular assay kit manufacturing under cGMP
- Experience with process validation, statistics including DOE, and continuous improvement
- Demonstrated project management skills
- Familiarity with design controls, Good Documentation Practices, cGMP, and FDA/ISO quality standards for medical device and IVD products
- Proficiency in Excel for manufacturing records and data analysis templates
- Immunoassay experience is a strong plus
- Familiarity with CLSI guidelines, immunoassays, and AI tools for process automation are pluses
Benefits
Comp & perks- Meaningful stock ownership
- Comprehensive benefits
- Competitive compensation
- Bonus