Principal Engineer, Process Development - OSD
Alkermes
August 18, 2026
On-site
Greater Boston
Operations
Responsibilities:
- Provide subject matter expertise in process development methodologies for internal/external execution and technical oversight.
- Guide and drive process development, design of experiments (DoE), product characterization, and control strategy development.
- Design and execute ICH/FDA-aligned process development activities for late-stage small-molecule development (Phase 3 to PPQ).
- Collaborate with Pharmaceutical Development and Manufacturing to leverage internal/external capabilities.
- Provide timely technical support and management oversight for process development activities at external partners.
- Develop/review/approve process development source documents; author/review drug product process development sections for regulatory submissions.
- Present technical data to cross-functional teams and senior management; communicate critical process issues and solutions.
- Identify and advocate new/emerging process development technologies.
- Manage, train, and mentor junior Process Development staff.
- Perform other duties as assigned.
Qualifications:
- PhD (>8 years) or MS (>15 years) in Science or Engineering.
- Demonstrated expertise in small-molecule process development, scale-up, and technical transfer.
- Expertise in DoE, data analysis, and data interpretation.
- Experience managing contract drug development (CDMO) activities.
- Strong technical problem-solving using current research and technologies.
- Broad understanding of the drug development process and process development’s role.
- Collaborative leadership; strong verbal/written communication.
- Expert understanding of ICH, FDA, and USP guidelines; ability to apply by development stage.
- Proficiency with powder blending, granulation, compression, encapsulation, Wurster coating, pan coating.
- Ability to work in a fast-paced matrix environment and independently manage priorities/timelines.
- Process Analytical Technology (PAT) experience preferred.
Travel Requirements:
- Travel as needed; serve as primary technical representative during critical manufacturing activities and provide onsite leadership during scale-up, technology transfers, validation, troubleshooting, and key milestones.
Compensation/Benefits (as stated):
- Base salary: $173,000–$193,000; eligible for annual performance pay bonus; competitive benefits package.
- Provide subject matter expertise in process development methodologies for internal/external execution and technical oversight.
- Guide and drive process development, design of experiments (DoE), product characterization, and control strategy development.
- Design and execute ICH/FDA-aligned process development activities for late-stage small-molecule development (Phase 3 to PPQ).
- Collaborate with Pharmaceutical Development and Manufacturing to leverage internal/external capabilities.
- Provide timely technical support and management oversight for process development activities at external partners.
- Develop/review/approve process development source documents; author/review drug product process development sections for regulatory submissions.
- Present technical data to cross-functional teams and senior management; communicate critical process issues and solutions.
- Identify and advocate new/emerging process development technologies.
- Manage, train, and mentor junior Process Development staff.
- Perform other duties as assigned.
Qualifications:
- PhD (>8 years) or MS (>15 years) in Science or Engineering.
- Demonstrated expertise in small-molecule process development, scale-up, and technical transfer.
- Expertise in DoE, data analysis, and data interpretation.
- Experience managing contract drug development (CDMO) activities.
- Strong technical problem-solving using current research and technologies.
- Broad understanding of the drug development process and process development’s role.
- Collaborative leadership; strong verbal/written communication.
- Expert understanding of ICH, FDA, and USP guidelines; ability to apply by development stage.
- Proficiency with powder blending, granulation, compression, encapsulation, Wurster coating, pan coating.
- Ability to work in a fast-paced matrix environment and independently manage priorities/timelines.
- Process Analytical Technology (PAT) experience preferred.
Travel Requirements:
- Travel as needed; serve as primary technical representative during critical manufacturing activities and provide onsite leadership during scale-up, technology transfers, validation, troubleshooting, and key milestones.
Compensation/Benefits (as stated):
- Base salary: $173,000–$193,000; eligible for annual performance pay bonus; competitive benefits package.