Sr. Process Development Engineer - OSD
Alkermes
August 18, 2026
On-site
Greater Boston
Operations
Responsibilities:
- Act as SME in oral solid dosage (OSD) processing; adopt new technologies; provide technical guidance, training, and direction.
- Lead lab-scale process development; ensure knowledge transfer to pilot-scale via reports, presentations, and technical collaboration.
- Design and execute experiments to deepen process knowledge, optimize performance, and improve product robustness.
- Support GMP clinical manufacturing facility operations for OSD forms.
- Oversee GMP batch manufacturing at multiple scales, ensuring safety, quality, and documentation compliance.
- Create batch records, change controls, and SOPs with focus on efficiency and continuous improvement.
- Author CMC sections for IND, NDA, and other regulatory filings.
- Develop process trains/flows with scalable, reproducible processes and well-defined critical parameters.
- Maintain compliance with cGMP, safety, and environmental legislation and company policies.
- Present technical data; communicate risks/solutions; collaborate with formulators, engineers, safety, and quality teams.
- Mentor and train junior staff.
Qualifications:
- Ph.D. +3 years; M.S. +10 years; B.S. +15 years in engineering/scientific discipline in pharmaceutical solid oral dosage processing.
- Proficiency across powder blending, encapsulation, granulation, compression, and coating.
- Ability to work in fast-paced matrix environments and independently manage priorities/timelines.
- Collaborative leadership; strong verbal and written communication.
- Experience in small molecule process development, scale-up, and technical transfer.
Preferred Requirements:
- Design of experiments (DOE), data analysis, and interpretation.
- Understanding of drug development lifecycle and role of process development.
- Expertise in mechanical/chemical engineering principles applied to process systems and OSD equipment.
- Hands-on instrumentation/equipment installation and troubleshooting; process safety and risk assessment knowledge.
- Technical problem-solving using current research/technologies.
- Knowledge of ICH, FDA, and USP guidelines; apply by development stage.
- Process Analytical Technology (PAT) and drug product formulation experience.
- Minimal travel (10–15%).
- Act as SME in oral solid dosage (OSD) processing; adopt new technologies; provide technical guidance, training, and direction.
- Lead lab-scale process development; ensure knowledge transfer to pilot-scale via reports, presentations, and technical collaboration.
- Design and execute experiments to deepen process knowledge, optimize performance, and improve product robustness.
- Support GMP clinical manufacturing facility operations for OSD forms.
- Oversee GMP batch manufacturing at multiple scales, ensuring safety, quality, and documentation compliance.
- Create batch records, change controls, and SOPs with focus on efficiency and continuous improvement.
- Author CMC sections for IND, NDA, and other regulatory filings.
- Develop process trains/flows with scalable, reproducible processes and well-defined critical parameters.
- Maintain compliance with cGMP, safety, and environmental legislation and company policies.
- Present technical data; communicate risks/solutions; collaborate with formulators, engineers, safety, and quality teams.
- Mentor and train junior staff.
Qualifications:
- Ph.D. +3 years; M.S. +10 years; B.S. +15 years in engineering/scientific discipline in pharmaceutical solid oral dosage processing.
- Proficiency across powder blending, encapsulation, granulation, compression, and coating.
- Ability to work in fast-paced matrix environments and independently manage priorities/timelines.
- Collaborative leadership; strong verbal and written communication.
- Experience in small molecule process development, scale-up, and technical transfer.
Preferred Requirements:
- Design of experiments (DOE), data analysis, and interpretation.
- Understanding of drug development lifecycle and role of process development.
- Expertise in mechanical/chemical engineering principles applied to process systems and OSD equipment.
- Hands-on instrumentation/equipment installation and troubleshooting; process safety and risk assessment knowledge.
- Technical problem-solving using current research/technologies.
- Knowledge of ICH, FDA, and USP guidelines; apply by development stage.
- Process Analytical Technology (PAT) and drug product formulation experience.
- Minimal travel (10–15%).