Senior Process Engineer, MSAT, Drug Substance

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Deliver technical leadership and daily process engineering support for the manufacturing of clinical and commercial drug substances at external CDMOs.

• Act as the subject matter expert in process engineering during manufacturing operations, providing onsite assistance as necessary.

• Lead investigations, conduct root cause analyses, and formulate scientifically sound CAPAs.

• Draft technical risk assessments and change controls related to manufacturing modifications, investigations, and regulatory submissions.

• Ensure adherence to cGMPs, global regulatory standards, and internal quality systems.

• Review and contribute technical expertise to master batch records, campaign readiness plans, process descriptions, and manufacturing documentation.

• Oversee drug substance technology transfer between clinical, validation, and commercial manufacturing sites.

• Define critical process parameters, critical quality attributes, and in-process controls for peptide drug substance operations.

• Develop and implement process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria.

• Offer technical authorship and review for IND, BLA, NDA, and MAA submissions, validation reports, and regulatory responses.

• Assist with drug substance introductions and commercial launches by ensuring processes are validated, scalable, robust, and ready for inspection.

• Lead continued process verification and routine data trending.

• Create and maintain data repositories, dashboards, and KPIs to evaluate process capability, performance, and trends.

• Identify process drift, yield loss, impurity shifts, raw material variability, and scale-dependent risks; drive corrective or preventive measures.

• Prepare and present quarterly CPV summaries and technical evaluations for management reviews.

• Implement continuous improvement initiatives aimed at enhancing process robustness, impurity control, yield, cycle time, capacity, and operational efficiency.

• Utilize Quality by Design, Design of Experiments, statistical process control, and risk-based decision-making.

• Collaborate with CDMOs to apply best practices, introduce new technologies, and enhance processes.

⛳️ Requirements

• Bachelor’s degree in chemical engineering or a related discipline with 8 or more years of pertinent experience, or a master’s degree with 5 or more years of relevant experience.

• Experience in supporting late-phase or commercial peptide or biologic drug substance manufacturing, including chromatography purification, ultrafiltration or diafiltration, and lyophilization.

• In-depth knowledge of cGMP principles, quality systems, global regulatory expectations, as well as process, equipment, and facility validation requirements.

• Proven experience with technology transfer, process validation, continued process verification, manufacturing investigations, CAPAs, risk assessments, and change control.

• Capability to analyze complex manufacturing data, detect subtle process trends, and convert findings into actionable, scientifically sound strategies.

• Demonstrated ability to lead technical discussions with external partners and influence cross-functional decisions without direct authority.

• Exceptional written and verbal communication skills, enabling clear communication of complex process risks to both technical and non-technical stakeholders.

• Willingness to travel domestically and internationally to CDMO sites, up to 20% of the time.

• Preferred: Experience in liquid-phase, hybrid, tag-assisted synthesis, or green chemistry methodologies for peptide manufacturing.

• Preferred: Familiarity with modeling, statistical analysis, or process optimization tools such as MATLAB or JMP.

• Preferred: Experience in supporting regulatory submissions, addressing health authority inquiries, inspections, and ensuring commercial launch readiness.

• Must have access to a remote work environment that offers privacy, reliable internet, phone, and video conferencing capabilities.

• Applicants must reside and/or work in the United States; applications from Alaska and Hawaii are currently not being considered.

🏝️ Benefits

• Annual performance-based bonuses for eligible employees.

• Equity awards for eligible employees.

• Comprehensive benefits package that supports health, well-being, and financial security.

• Remote work opportunities available within the United States.

• Company-related events.

• Commitment to equal opportunity employment.

• Accommodations provided during the selection process.