Senior Process Development Engineer - OS Dosage Forms

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

Job summary

Alkermes is seeking a Senior Engineer to lead oral solid dosage processing development in a GMP clinical manufacturing setting. The role requires deep expertise in milling, blending, granulation, compression and coating, with a track record of cross-functional leadership.

You will design and execute experiments, optimize processes, transfer knowledge to pilot scale, and ensure compliance with safety and quality standards while advancing early-stage development projects in Massachusetts.

Qualifications

• Ph.D. and 3+ years in engineering/scientific discipline; M.S. and 10+ years of related experience; B.S. and 15+ years of related experience in pharmaceutical solid oral dosage processing.
• Subject matter proficiency across processing techniques such as powder blending, encapsulation, granulation, compression, and coating.
• Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
• Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
• Demonstrated experience in small molecule process development, scale up and technical transfer.

Responsibilities

• Act as a subject matter expert in oral solid dosage processing, quickly adopt new technologies, and provide technical guidance, training, and direction to teams.
• Lead lab-scale process development and ensure effective knowledge transfer to pilot-scale manufacturing through reports, presentations, and technical collaboration.
• Design and execute experiments to deepen process knowledge, optimize performance, and improve product robustness.
• Support the operation of a GMP clinical manufacturing facility, enabling diverse processing capabilities and supporting early-stage development activities.
• Oversee batch manufacturing activities, ensuring adherence to safety, quality, and documentation standards while producing GMP batches at multiple scales.
• Responsible for the creation of batch records, change controls and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement.
• Author CMC sections for IND, NDA, and other regulatory filings.
• Develop process trains and flows, ensuring scientifically driven, scalable, and reproducible processes with well-defined critical parameters.
• Maintaining compliance with all aspects of cGMP, safety and environmental legislation and company policies.
• Present technical data to stakeholders, communicate risks and solutions, and collaborate with formulators, engineers, safety, and quality teams.
• Mentor and train junior staff.

Skills

Process development

Leadership

Oral solid dosage

Scale-up

Data analysis

Education

Ph.D.

M.S.

B.S.

Job description

Alkermes is seeking a Senior Engineer to lead oral solid dosage processing development in a GMP clinical manufacturing setting. The role requires deep expertise in milling, blending, granulation, compression and coating, with a track record of cross-functional leadership.

You will design and execute experiments, optimize processes, transfer knowledge to pilot scale, and ensure compliance with safety and quality standards while advancing early-stage development projects in Massachusetts.