Senior MSAT Process Engineer – GMP & Tech Transfers

elevatebio; Waltham (MA); On-site; USD 59,000 - 79,000; Full time

Job summary

ElevateBio is seeking a Senior Associate Process Engineer in MSAT to provide process science support for GMP manufacturing, tech transfers, development studies, and continuous improvement across cell and gene therapy modalities. You will contribute to protocols, product impact assessments, root-cause analyses, and technical reports while working with a cross-functional team.

The role requires a life sciences or engineering degree, 3+ years in MSAT or related areas, and familiarity with GMP

Qualifications

• Bachelor’s degree in life sciences, engineering, biotech, or related field.
• 3+ years in MSAT, manufacturing, or process development.
• Knowledge of biotech pharma manufacturing, aseptic processing, and cell culture.
• Experience in cell and gene therapy and aseptic processing preferred.
• Understanding of process development, validation, lifecycle management, and licensure changes.
• Strong communication and cross-functional collaboration skills.
• Familiarity with GMP electronic systems such as Veeva or eBRs.

Responsibilities

• Support tech transfers and cGMP manufacturing for clinical and commercial programs.
• Author/review protocols, technical reports, work instructions, SOPs.
• Own deviations, investigations, CAPAs, and change controls.
• Assist root-cause analysis of process deviations with cross-functional teams.
• Support gap analyses and risk assessments for capital projects and tech transfers.

Skills

MSAT experience

Cell culture

Aseptic processing

Process development

Documentation

Cross-functional collaboration

Veeva

Education

Bachelor’s degree in Life Sciences / Engineering / Biotechnology

Tools

Veeva

Electronic batch records

Job description

ElevateBio is seeking a Senior Associate Process Engineer in MSAT to provide process science support for GMP manufacturing, tech transfers, development studies, and continuous improvement across cell and gene therapy modalities. You will contribute to protocols, product impact assessments, root-cause analyses, and technical reports while working with a cross-functional team.

The role requires a life sciences or engineering degree, 3+ years in MSAT or related areas, and familiarity with GMP