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:
ElevateBio is looking for a Senior Associate Process Engineer within Manufacturing Technology and Sciences organization. As a Senior Associate Process Engineer in Manufacturing Science and Technology, you will provide technical support for GMP manufacturing including support for Visual Inspection (VI) Program, Deviation and Investigation, Change Control and CAPA implementations and continuous improvement projects within a highly matrixed cross functional team for Base Camp programs. As part of support, you will write protocols, product impact assessments, root-cause analysis reports, technical reports. You will support data collection and charting for non-GMP and GMP batches.
Here’s What You’ll Do:
- Work cross-functionally across Manufacturing, Quality and Supply Chain to provide support for cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral vector.
- This individuals focus areas would include support for Visual Inspection program.
- Own and maintain VI related documents
- Maintain VI qualification program including kits and training.
- Monitor and analyze VI related data and own data review meeting and annual data report.
- Own VI related deviations, investigations, product impact statement and related CAPAs
- Work closely with Tech Transfer teams to implement VI program for new program introductions
- Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, work instructions, SOPs.
- Own and support quality events such as deviations, investigations, CAPA, Change Control.
Requirements:
- Bachelor’s Degree in Life Sciences, Engineering, or a related technical discipline, or equivalent experience
- 3+ years of experience in a MSAT, manufacturing or process development role
- Experience in cell and gene therapy, aseptic processing, or parenteral drug product inspection preferred
- Strong communication skills and ability to work cross-functionally with technical and quality teams
- Familiarity with electronic systems used in GMP environments such as Veeva, or electronic batch records
The budgeted range for this position is $90,000-$120,000. This range is a good faith estimate of the expected salary 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 Life Sciences, Engineering, or a related technical discipline
- 3+ years of experience in a MSAT, manufacturing or process development role
- Experience in cell and gene therapy, aseptic processing, or parenteral drug product inspection
- Strong communication skills and ability to work cross-functionally with technical and quality teams
- Familiarity with electronic systems used in GMP environments such as Veeva, or electronic batch records
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.
