QC Dev Scientist

POSITION SUMMARY:

The Quality Control Development Scientist is responsible for modifying existing methods and/or developing and optimizing new QC methods to support routine lot release of reagents and kits used in the CLIA laboratory. The Scientist carries out experiments and studies to support bio-chemical verification and validation efforts and may provide guidance and/or supervision to junior-level team members.

PRIMARY RESPONSIBILITIES:

• Design and development of reagent Quality Control (QC) Tests and associated bio-chemical process optimizations to support routine reagent and kit qualification
• Analyze data and prepare documentation for QC method validation, author and revise QC testing SOPs and reports to ensure the successful implementation of assays in the laboratory
• Oversee technical transfer of new product QC methods from Research and Development into Operations, addressing process development needs for implementation
• Participate in troubleshooting efforts and help drive key decisions
• Build rapport with end-users, lab supervisors, and process owners and work collaboratively within cross functional teams
• Strong data analysis skills including setting specifications and monitoring reagent/kit lot performance
• Development and qualification of control reagents/samples and associated protocols  
• Interface with reagent manufacturers / suppliers, plan and execute equivalency studies with Purchasing team
• Manage multiple tasks and changing priorities in a fast-paced environment
• Strong and effective communication skills, including writing protocols and summarizing results in a report or presentation.  May review and edit protocols and reports by other scientific staff members.
• Professionally handle access to HIPAA information
• This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• Masters / PhD in Molecular Biology or related field plus a minimum of 2 years of experience in Industry.
• OR
• Bachelor's in Molecular Biology or related field plus a minimum of 6 years of experience in Industry.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Previous experience working in Assay Development or QC lab is highly desired.
• Experience in library construction for NGS, with emphasis on Process Development and optimization of diagnostic assays in a CLIA or FDA regulated laboratory environments is highly desired.
• Hand-on laboratory experience, particularly in reagent preparation and qualification assay development.
• Understanding of essential molecular biology methods such as PCR, nucleic acid purification, gel electrophoresis, analysis tools and instrumentation, DNA quantitation, and quality control are required.