Senior OSD Process Development Engineer

Alkermes, Inc.; Waltham (MA); On-site; USD 140,000 - 154,000; Full time

Job summary

Alkermes, Inc. in the United States seeks a Senior Engineer to lead process development for oral solid dosage forms. You will guide cross-functional teams, design experiments, and drive scale-up from lab to pilot manufacturing while ensuring GMP compliance.

The role requires deep knowledge of OSD manufacturing techniques (milling, blending, granulation, compression, coating) and ability to deliver robust, scalable processes. Strong communication and leadership skills are essential.

Qualifications

• Ph.D. with 3+ years (MS 10+ years, BS 15+ years) in pharmaceutical solid oral dosage processing.
• Experience with milling, blending, granulation, compression, encapsulation and coating.
• Ability to work in a fast-paced, matrix environment and lead teams.
• Excellent verbal and written communication and leadership skills.

Responsibilities

• Act as a subject matter expert in oral solid dosage processing.
• Lead lab-scale process development and transfer to pilot-scale manufacturing through reports and collaboration.
• Design and execute experiments to deepen process knowledge and robustness.
• Support GMP clinical manufacturing and early-stage development activities.
• Oversee batch manufacturing, ensuring safety, quality, and documentation standards while producing GMP batches.
• Create batch records, change controls and SOPs with a focus on efficiency and continuous improvement.
• Author CMC sections for IND, NDA, and other regulatory filings.
• Develop process trains and flows, ensuring scalable, reproducible processes with well-defined parameters.
• Maintain compliance with cGMP, safety and environmental regulations and company policies.
• Present technical data to stakeholders and collaborate with formulators, engineers, safety and quality teams.
• Mentor and train junior staff.

Skills

Process development

Oral solid dosage

Scale-up

Cross-functional leadership

Regulatory knowledge

Education

Ph.D. in engineering/science

M.S. in engineering/science

B.S. in engineering/science

Job description

Alkermes, Inc. in the United States seeks a Senior Engineer to lead process development for oral solid dosage forms. You will guide cross-functional teams, design experiments, and drive scale-up from lab to pilot manufacturing while ensuring GMP compliance.

The role requires deep knowledge of OSD manufacturing techniques (milling, blending, granulation, compression, coating) and ability to deliver robust, scalable processes. Strong communication and leadership skills are essential.