Principal Engineer-Oral Solid Dosage; OSD), Manufacturing, Science & Technology; MSAT

Principal Engineer-Oral Solid Dosage (OSD), Manufacturing, Science & Technology (MSAT) Job Description

We are seeking a highly experienced and technically accomplished Principal Engineer to serve as the technical leader for Oral Solid Dosage (OSD) platform within our Manufacturing Science & Technology (MSAT) organization.

This role will lead the site’s OSD commercial manufacturing technical support activities, technology transfers, and continuous improvement initiatives. The Principal Engineer will be responsible for solving complex technical challenges, strengthening process understanding, and ensuring robust, compliant, and efficient manufacturing processes.

This position is designed for a deep technical expert who thrives in solving complex problems, influencing cross‑functional teams, and driving meaningful improvements in cost, yield, and product quality.

Technical Leadership & Platform Development

• Serve as the site-wide technical authority for OSD manufacturing processes
• Define and evolve the OSD technical platform, including process standards and best practices
• Establish strong process knowledge and improve control strategies across products and unit operations
• Act as the site’s technical representative for new product entry on cross‑functional development programs

Manufacturing Support & Troubleshooting

• Lead complex investigations related to process deviations, atypical events, and product quality issues
• Provide hands‑on technical support to manufacturing operations
• Perform structured root cause analysis and implement sustainable corrective actions
• Support technical activities for new product introductions (NPI) and technology transfers from R&D into the site
• Ensure effective translation of process knowledge from development to commercial manufacturing
• Lead both intra and inter site tech transfer of established commercial processes
• Support process validation and lifecycle management strategies
• Drive initiatives to improve yield, throughput, and cost of goods (COGs)
• Apply data‑driven and scientific approaches to enhance process robustness
• Identify and implement process and equipment optimization opportunities

Cross‑Functional Collaboration

• Partner with Manufacturing, Quality, Engineering, Pharm Dev, Technical Operations and Validation to ensure successful execution of technical initiatives

Serve as a trusted technical advisor across the organization

Regulatory & Compliance Support

• Ensure all activities meet GMP and regulatory expectations
• Support regulatory submissions, inspections, and audits as a subject matter expert
• Author and review technical documentation, investigations, and reports

Education and Experience

• Master’s degree in Engineering, Pharmaceutical Sciences, or related field (required)
• Ph.D. (preferred)

Experience

• Minimum 15 years of experience in pharmaceutical manufacturing or development
• Significant experience in oral solid dosage processes and technologies
• Proven track record in:
• Complex problem‑solving and troubleshooting
• Technology transfer and scale‑up
• Process optimization and continuous improvement

Technical Skills

• Strong expertise in OSD unit operations (e.g., blending, granulation, compression, coating; both cosmetic and functional)
• Experience with data analysis, statistics, and process modeling
• Deep understanding of GMP and regulatory requirements

Leadership Attributes

• Demonstrated ability to lead without authority and influence cross‑functional teams
• Strong communication skills, with the ability to translate complex concepts into practical solutions

Ability to operate effectively in a fast‑paced, technically complex environment

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Alkermes is an E‑Verify employer.