Position Overview
The Staff Scientist, Product Support will lead and oversee technical support activities within Operations. This role investigates issues through root cause analysis and implements corrective actions via the Quality Management System, supporting Production and Quality Control groups through continuous improvement initiatives. The position reports to the Manager, Product Support, in Manufacturing Sciences and Operations.
Essential Duties
Include, but are not limited to, the following:
- Provide technical and product support leadership in Operations working cross-functionally with the Production, QC, Supply Chain, R&D, and Quality teams.
- Lead troubleshooting of Out of Specification events (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
- Lead moderate to highly complex projects. Able to generate plans, identify project and business risk, and communicate progress and status to Operations Leadership. Lead team execution toward project milestones according to project timelines and apply recognized project management and scheduling tools.
- Provide technical leadership and support for PCR-based and/or NGS-based reagents and products.
- Provide support to Operations teams for qualifying new raw materials and alternative supply channels for products.
- Lead investigations into analytical and functional test methods and associated equipment during the transfer process of methods into operations.
- Develop analytical test methods and characterize complex manufacturing processes incorporating industry standard techniques.
- Characterize assay and formulation variability using Measurement System Analysis (MSA) and Design of Experiment (DOE) for complex systems.
- Clearly and accurately generate experimental protocols, draft work instruction and test method procedures, and summarize development activities through technical summary reports.Program, operate, and troubleshoot complex instrumentation such as microplate readers, real-time and digital polymerase chain reaction (PCR) instruments, next-generation sequencers, and liquid handling automation.
- Apply basic and advanced statistical techniques: assessing data normality, control charting and data trending, hypothesis testing, assessing variation, linear regression and model fitting, DOE, MSA, Multivariate Analysis, and ANOVA.
- Analyze data to identify trends, assists/leads troubleshooting and root cause investigation efforts with ability to utilize recognized root cause analysis tools.
- Leads investigations into complex analytical and functional assays, associated equipment, materials, and/or processes, leads CAPA plans.
- Write new and edit existing Quality System documents (e.g. work instructions, standard operating procedures). Identify Continuous improvement opportunities for the Quality System. Responsible for generating/driving corrective actions/action plans for more complex changes.
- Collaborate with other departments (Quality Engineering, R&D, Regulatory Affairs, Supply Chain, Production, Validation, Quality Control) to achieve business results. Able to meet objectives without negatively impacting other functions.
- Lead low to moderately complex projects at a program level. Generate project plans, identify risk, and communicate status to Operations Leadership. Lead team execution toward project milestones according to project timelines and apply recognized project management and scheduling tools.
- Function independently with limited guidance from supervisor as well as part of a team. Capable of leading teams to achieve business results. Proactive and forward thinking to plan and shift directions based on priorities/need.
- Excellent verbal and written communication skills.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work nights and/or weekends, as needed.
- Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s degree in life sciences or field related to the essential duties of the job.
- 10+ years of experience in the life sciences industry. Master’s or Doctoral degrees may be considered in lieu of 2 years of experience.
- 6+ years working within an FDA 21 CFR 820, ISO 13485, ISO12207, and/or cGMP structured environment.
- Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint).
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- Proficiency with statistical analysis software and/or programing (e.g. JMP, R).
- Advanced Degree in Biology, Chemistry, or similar discipline (MS, PhD).
- Experience developing automated liquid handling workflows on Hamilton robotic platforms.
- Experience with _in-vitro_ diagnostic product development, design transfer, manufacturing, or product support.
- Strong knowledge of continuous improvement methodologies/principles.
- Six Sigma Green Belt (or higher) Certification.
- Familiarity with Project Management Principles and Practices.
- Experience using Enterprise Resource Planning (ERP) software (SAP preferred).
- Experience using Electronic Quality Management System (EQMS) software (Agile preferred).
- Familiarity with CAP/CLIA regulatory requirements as they pertain to _in vitro_ diagnostics.
