Lead Process Development Engineer, OSD Manufacturing

Alkermes; Boston (MA); On-site; USD 140,000 - 154,000; Full time

Job summary

Alkermes is seeking a Senior Engineer in Process Development to provide technical leadership for small molecule oral solid dosage forms. You will guide cross-functional teams, design experiments, and drive robust, scalable manufacturing processes.

The role includes GMP manufacturing in a clinical setting, batch record creation, and support for IND/NDA filings. You will lead process development activities, collaborate with CMC teams, and mentor junior staff while maintaining compliance with ICH,

Qualifications

• Experience in oral solid dosage processing techniques used for manufacture of dosage forms (OSD).
• Ability to lead process development activities in a GMP facility.
• Experience with IND/NDA/CMC regulatory filings.
• Strong analytical and data interpretation skills for process improvement.

Responsibilities

• Act as SME in OSD processing and provide technical guidance to teams.
• Lead lab-scale process development and mentor knowledge transfer to pilot-scale manufacturing.
• Design and execute experiments to deepen process knowledge and optimize performance.
• Support GMP clinical manufacturing and ensure adherence to safety, quality, and documentation standards.
• Oversee batch manufacturing activities across multiple scales and generate batch records and change controls.
• Develop and document process trains, critical parameters, and SOPs.

Skills

Oral Solid Dosage Processing

Milling

Blending

Granulation (Wet/Dry)

Compression

Encapsulation

Coating

Process Design

Data Analysis

FDA/ICH Guidelines Awareness

Tools

Process Analytical Technology (PAT)

Job description

Alkermes is seeking a Senior Engineer in Process Development to provide technical leadership for small molecule oral solid dosage forms. You will guide cross-functional teams, design experiments, and drive robust, scalable manufacturing processes.

The role includes GMP manufacturing in a clinical setting, batch record creation, and support for IND/NDA filings. You will lead process development activities, collaborate with CMC teams, and mentor junior staff while maintaining compliance with ICH,