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 Senior Scientist, QC Microbiology will perform assay development, characterization, optimization, transfer, qualification, verification, validation and investigation for QC Microbiology group. The role will provide technical support and guidance related to environmental monitoring, release, stability, and in-process testing and method development. This role will train staff, support laboratory/cleanroom start-up and qualification, and support that the company’s sterility assurance and contamination control strategies are compliant with current industry and regulatory standards. In addition, this role will work cross-functionally with Quality Assurance and Manufacturing to support the production of cell and gene therapy products through safety testing, environmental monitoring testing and supporting investigations
Here’s What You’ll Do:
- Facilitate and oversee microbiological method transfer, qualification, verification, and validation to support internal and client programs.
- Evaluate and onboard microbiological methodologies, techniques, equipment, instruments, and capabilities for sample testing, facility & utility monitoring.
- Support setting of product specifications, process control strategies, environmental alert and action limits.
- Serve as key subject matter expert for Contamination Control and Sterility Assurance programs
- Interpret microbial identifications and provide microbial impact assessments related to investigations
- Facilitate and participate in risk assessments related to aseptic and microbiological environmental controls
- Participate in technical troubleshooting and investigations.
- Review analytical development reports, test method and process qualification reports and other technical documents for technical correctness and regulatory compliance.
- Develop, deliver and coach on theory, technical and aseptic training for analysts, operators and technicians.
- Assist in the generation, review and approval of protocols, reports, and CofAs.
- Prepare, evaluate, and present data internally to cross functional teams.
- M.S. or Ph.D. in Microbiology, Virology, or equivalent with 8+ years relevant experience.
- Strong communication, interpersonal and organizational skills
- Ability to work with others to resolve complex technical and scientific problems
- Broad technical proficiency, ability to solve complex issues independently
- Significant laboratory documentation experience
- Experience performing laboratory and/or manufacturing investigations.
- Experience in GxP requirements of biopharmaceutical manufacturing and testing
- Experience with aseptic processing and clean room operations per ISO 14644.
- Experience with compendial safety testing (e.g. bioburden, mycoplasma, endotoxin and sterility) including rapid methodologies (e.g. BacT Alert and PCR).
- Experience in statistical analysis and visual data presentation is desirable.
- Knowledge of human cell, tissue, and cellular and tissue-based products (HCT/P), or cell and gene therapy production is desirable.
- Familiarity or experience with medical microbiology, clinical microbiology, or healthcare setting microbiology is desirable.
- Knowledge and experience with molecular and cell biology, virology and/or immunology is desirable
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.
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
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.