ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role:
The Associate I, QC Microbiology is responsible for performing routine activities at our Waltham facility. This role will be responsible for ensuring daily functions and responsibilities of the QC Microbiology group within the laboratory and clean rooms are completed accurately and efficiently. Activities of this position include but are not limited to, laboratory assays, environmental monitoring activities, data entry, and review. This is a 6-month contract.
Here’s What You’ll Do:
- Perform routine environmental monitoring, utility monitoring, and safety testing of Cell Therapy drug products, ensuring that all work is carried out per cGMPs and applicable policies and procedures.
- Perform standard QC Microbiological assays.
- Bioburden, Endotoxin, Sterility, Growth Promotion, TOC/Conductivity, etc.
- Peer-reviewing assay results.
- Performing routine Data Entry/Review with LIMS systems.
- Perform routine QC Microbiology Environmental Monitoring and Utility Monitoring testing in Grade A/B/C and D cleanrooms.
- Perform routine Preventative Maintenance (PMs) for QCM Equipment.
- Support Quality Events including: Laboratory Investigations, Deviations, CAPA’s, Change Controls and associated Quality Actions.
Requirements:
- Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with 0-2 years of experience in a GMP Quality Control microbiology lab setting.
- Ability to communicate and work collaboratively cross departmentally and within a team, as well as being able to complete tasks independently for routine tasks.
- Excellent Organizational skills and attention to detail is required.
- Ability to follow and execute SOP’s.
Skills & Competencies:
- Knowledge of GMP, GLP, SOPs, and quality system processes a plus.
- Environmental monitoring as it applies to USP/ISO/EU Regulations
- Experience in Cell and Gene Therapy manufacturing environment is a plus.
- Experience with MODA, Veeva, Kneat, SAP, and BMRAM is a plus.
Work Environment & Physical Demands:
- Able to lift and carry 20 lbs (equipment/materials)
- Ability to be on feet for 4 hours at a time
- Ability to Aseptically Gown
- Able to support Off-Shift Hours for Product testing
The budgeted range for this position is $33/hour - $48/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
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.
Skills Required
- Bachelor's degree in Biology, Chemistry, Microbiology, Engineering, or related field with 0-2 years QC microbiology GMP lab experience
- Ability to communicate and work collaboratively cross-departmentally and complete routine tasks independently
- Excellent organizational skills and strong attention to detail
- Ability to follow and execute Standard Operating Procedures (SOPs)
- Knowledge of GMP, GLP, SOPs, and quality systems (USP/ISO/EU environmental monitoring)
- Experience in cell and gene therapy manufacturing environment
- Experience with MODA, Veeva, Kneat, SAP, and BMRAM
- Perform data entry/review with LIMS systems
- Able to lift and carry 20 lbs and be on feet for 4 hours at a time
- Ability to aseptically gown
- Willingness to support off-shift hours for product testing
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare. ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
