Senior Engineer, MSAT

This is a fully remote position, open to applicants in Kentucky, +12 more states.

📋 Description

• Execute and assist in technology transfer workstreams for late-stage clinical and commercial manufacturing locations.

• Strategize transfers, implement processes, facilitate site readiness, deliver training, and carry out manufacturing activities.

• Conduct and support assessments for new site and suite readiness, including evaluations of facility-fit, feasibility, technical aspects, equipment, processes, personnel, and documentation.

• Draft and assist in the creation of technology-transfer documentation, protocols, risk assessments, batch records, troubleshooting guides, process playbooks, change controls, and training materials.

• Collaborate with manufacturing sites and Contract Development and Manufacturing Organizations (CDMOs) to ensure that technology, equipment, materials, personnel, processes, and documentation meet compliant GMP manufacturing standards.

• Provide on-site technical support as a Person-in-Plan during feasibility, engineering, GMP, comparability, and validation campaigns.

• Troubleshoot manufacturing challenges and aid in the resolution of technical issues and GMP deviations.

• Identify and drive continuous improvement initiatives through risk assessment, change control, transfer-package development, and implementation.

• Implement process knowledge and control strategies at receiving manufacturing sites, encompassing Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), in-process controls, operating ranges, monitoring requirements, and escalation criteria.

• Establish data capture and trending during technology transfer and transition to routine manufacturing.

• Conduct statistical analyses using JMP or similar tools to assess process performance, variability, trends, and shifts.

• Align cross-functionally with teams in Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain.

• Act as a subject-matter expert in technical and GMP manufacturing.

• Perform other duties as assigned.

⛳️ Requirements

• A Bachelor’s, Master’s, or Ph.D. degree in a scientific or engineering discipline is required.

• 7 or more years of relevant industry experience with a Bachelor's degree; 4 or more years of experience with a Master's or Ph.D.

• A minimum of 3 years of experience in MS&T, Manufacturing, or Process Development specifically for biologics/cell therapies.

• Required experience in late-stage clinical, BLA-enabling, or commercial manufacturing activities.

• Proven experience in supporting or leading technology transfers for biologics, cell therapies, or other complex manufacturing processes.

• Direct experience working with CDMOs or external manufacturing sites during technology transfer and/or GMP manufacturing is essential.

• Comprehensive understanding of cGMP regulations, ICH guidelines, and regulatory expectations for biologics or cell therapy manufacturing.

• Strong technical writing capabilities with experience in authoring/reviewing protocols, reports, risk assessments, batch records, technical assessments, and source documents for regulatory submissions.

• Excellent communication and interpersonal skills are crucial.

• Background in cell therapy, viral vector, or other complex biologic modalities with experience in GMP manufacturing and Person-in-Plan (PiP) roles.

• Ability to independently manage technical projects and workstreams with minimal daily supervision.

• Experience in conducting or facilitating technical, process, facility-fit, and manufacturing risk assessments utilizing FMEA or similar methodologies.

• Strong analytical and problem-solving skills with a data-driven approach to process troubleshooting.

• Expertise in deviation management, change control, and CAPA processes.

• Proficiency in Microsoft Office tools and data analysis platforms, such as JMP and Excel.

• Willingness to travel up to 35%.

• Candidates must reside in one of the following states: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, or WA.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous Paid Time Off (PTO).

• Paid parking for employees.

• Subsidized commuter passes.

• Catered lunches in the office.

• Team-building events.

• Opportunities for community involvement.

• Competitive compensation packages.