Specialist I, QC Planner & Scheduler
ElevateBio
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The Role:
The Specialist I, QC Planner & Scheduler is an individual contributor role for cross-functional teams with the goal to improve productivity and effectively achieve core business activities for routine testing and analytical method transfer.
Here’s What You’ll Do:
Planner / Scheduler Routine Testing and Project Delivery:
- Coordinate with internal stakeholders to negotiate, prioritize and schedule routine, non-routine, and project work in QC to achieve business objectives
- Coordinate and own the lab testing schedule based on production schedules, analyst schedules and equipment availability
- Track testing completion for delivery of CoAs on time for batch disposition
- Ensure equipment is maintained in coordination with analyst schedules, Facilities & Engineering and Vendor availability
- Provide status and progress monitoring for QC owned Quality Event records to ensure timely completion and escalation.
- Track and lead Continuous Improvement projects within QC, including lean lab initiatives
- Provide routine updates to QC Management, Site Leadership Team and Project Teams
- Influence teams and organization to streamline site operational readiness and routine testing processes
- Track and report metrics for the QC Organization
- Take initiative to improve lab operations, ways of working, and lead by example and build collaborative relationships
Requirements:
- Bachelor’s degree in a relevant science related field is required (life sciences)
- 3+ years previous GXP QC Laboratory experience
Additional Preferences:
- Trained in Lean/Six-sigma Methodologies or interest in pursuing Lean certifications
- Trained in Project Management methodologies or interest in pursuing Project Management certifications
- Demonstrated strong self-management skills
- Demonstrated group facilitation and project management skills
- Good written and oral communication skills including effective presentation skills
- Good interpersonal skills
- Desire to solve complex problems with use of software tracking tools
- Ability to influence cross functionally and across different levels of the organization
- Knowledge of safety and GMP requirements
- Experience in a manufacturing environment
- Educational background in science
- Experience in regulatory inspections.
- Ability to think strategically and to influence others.
- Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
- Experience in electronic LIMS, Lab Scheduling tools, Project Management software, Enterprise Management systems, Quality Management Systems, Document Management Systems.
Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.