The Role:

ElevateBio is looking for a Senior Associate Process Engineer within the Manufacturing Science and Technology (MSAT) organization.  As a Senior Associate Process Engineer in MSAT, you will provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects within a highly matrixed cross-functional team for ElevateBio programs.  As part of support, you will write protocols, product impact assessments, root-cause analysis reports, and technical reports. You will additionally support data collection and charting for non-GMP and GMP batches.

Here’s What You’ll Do:

• Work cross-functionally across Process Development, Manufacturing, Quality, and Supply Chain to provide support for technology transfers and cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral vector.
• 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, CAPAs, and Change Controls.
• Assist in the root cause determination of process-related deviations in a timely and complete manner. The candidate will work with a cross-functional team to resolve complex problems using experience and efficient application of scientific methodology and technical reasoning, then propose comprehensive process solutions and improvements.
• Support gap analyses and risk assessments to support the capital projects and tech transfers.

Requirements:

• Bachelor’s Degree in Life Sciences, Engineering, Biotechnology, or a related technical discipline
• 3+ years of experience in a MSAT, Manufacturing, or Process Development role
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
• Experience in cell and gene therapy, aseptic processing, and drug manufacturing preferred
• Understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes
• 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 $43/hour - $57/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.