Business Process Analyst

INVIVOSCRIBE INC • San Diego, CA

35d

About The Position

Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 30 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 30 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Business Process Analyst who will be responsible for leading process improvement efforts in the company’s Operations, Manufacturing, and other functional areas by identifying and implementing innovative methodologies to automate or streamline processes. Primarily focuses on initiatives that leverage and optimize the company’s enterprise resource planning (ERP) system and advanced data analysis tools. Responsible for guiding critical business initiatives, ensuring they are planned and executed to successfully implement best-in-class solutions. Provides ongoing support for the resolution of business systems issues. Coordinates between operational departments and IT on a wide variety of technical improvement projects by actively managing or assisting various functional groups in IT improvement projects. Activities are performed independently and in accordance with standard operating procedures (SOPs), Quality Management System (QMS), safety and administrative regulations and policies.

Requirements

• Bachelor’s degree in engineering or other technical related field of study and, typically, 3-4 years’ applicable experience with project management, process improvement initiatives within life sciences, pharmaceuticals, or diagnostics operations. Equivalent combination of education and experience may be considered.
• Proficiency in Business Intelligence tools such as Power BI.
• Proficiency with ERP systems (e.g., Oracle Cloud).
• Sound knowledge of statistical methods and data modeling.
• Sound knowledge of Project Management concepts and tools. PMP certification advantageous.
• Proficient in Microsoft Office Suite and collaboration tools with the ability to learn new software programs. Advanced user of Excel, Word, and Power Point is required.

Nice To Haves

• Lean/Six Sigma certification preferred.

Responsibilities

• Partners with company management and IT team to identify and prioritize projects that optimize the ERP system for process automation and streamlining.
• Documents and bridges current state/future state by developing clear, actionable requirements for implementation.
• Develops and communicates detailed requirements and specifications for implementation of projects and system changes.
• Evaluates system or process modifications to assess their impact on business operations and provides well-informed recommendations.
• Demonstrates strong analytical skills and a thorough understanding of product and process flows.
• Communicates effectively and presents findings to various stakeholders, ensuring clarity and engagement.
• Applies advanced expertise in Power BI and Oracle Cloud to improve data analysis and reporting functions.
• Utilizes Value Stream Mapping and other Lean Six Sigma techniques to ensure the successful execution of projects.
• Provides analytical support including cost savings estimates, safety improvements, and quality enhancements associated with each project.
• Prepares and facilitates meetings with management, project stakeholders, and steering committees, providing timely updates to stakeholders.
• Produces reports, timelines, and graphics to communicate expectations and progress to management, customers, investors, and other relevant parties.
• Manages projects effectively to ensure clarity of scope, resource allocation, stakeholder input and buy-in, implementation, and post-implementation evaluation and reporting.
• Operates autonomously while achieving objectives and collaborates effectively with cross-functional teams to deliver results.
• Maintains proper documentation and coordinates or performs testing of system modifications to ensure accuracy and compliance.
• Complies with applicable standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies.
• Operates within Quality Management Systems and is familiar with CAPA, Non-conformities, and other quality management processes.
• Ensures compliance with ISO 13485, FDA and IVDR regulations in all relevant activities.

Benefits

• A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options.
• A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day.
• A positive workplace culture with an emphasis on support, respect and belonging.
• A diverse and inclusive work environment where you will learn, grow, and make new friends.
• Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees