Senior Process Engineer, MSAT, Drug Substance

Role overview

Own the technical performance and lifecycle of peptide drug substance manufacturing at external manufacturing partners. This senior process engineering role supports late-stage clinical and commercial production, connecting manufacturing operations with quality, regulatory, and CMC teams to keep processes reliable, compliant, and ready to scale.

Responsibilities

- Provide engineering guidance during manufacturing campaigns and attend partner sites when needed. - Lead technology transfers, process validation planning, continued process verification, and commercial launch readiness. - Define critical process parameters, quality attributes, in-process controls, sampling plans, and acceptance criteria. - Investigate deviations, conduct root cause analysis, and develop corrective actions, risk assessments, and change controls. - Review manufacturing records and technical documents, and contribute to regulatory submissions and agency responses. - Trend process data to spot drift, yield or impurity changes, and opportunities to improve robustness, capacity, and efficiency.

Requirements

- Bachelor’s degree in chemical engineering or a related field with at least 8 years of relevant experience, or a master’s degree with at least 5 years. - Experience supporting late-stage or commercial peptide or biologic drug substance manufacturing, including downstream operations such as chromatography, ultrafiltration or diafiltration, and lyophilization. - Strong knowledge of cGMP, quality systems, regulatory expectations, and process, equipment, or facility validation. - Hands-on experience with technology transfer, process validation, continued verification, investigations, CAPAs, risk assessments, and change control. - Ability to interpret complex process data, communicate risks clearly, and influence decisions across external partners and internal teams. - Willingness to travel domestically and internationally to manufacturing partner sites, up to 20%.

Nice to have

- Experience with liquid-phase, hybrid, or tag-assisted synthesis approaches. - Familiarity with Quality by Design, design of experiments, statistical process control, and risk-based process improvement.

Benefits and work setup

- Remote work is supported where the employee has a suitable private workspace, reliable internet, and phone and video conferencing access. The role includes several trips each year to a corporate location in Cambridge, Massachusetts, and travel to manufacturing sites. - Eligible employees may receive performance bonuses and equity awards, alongside a comprehensive benefits package.