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.
Responsibilities
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
Technology Transfer & Scale-Up
- 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
Continuous Improvement
- 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, PharmDev, 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
Qualifications
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
#LI-AH1
About Us
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
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.
VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
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.
Responsibilities
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
Technology Transfer & Scale-Up
- 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
Continuous Improvement
- 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, PharmDev, 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
Qualifications
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
#LI-AH1
About Us
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
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.
VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
About Alkermes, Inc.
At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. With our portfolio of marketed medicines and investigational pipeline candidates, we seek to make a meaningful difference in the way people manage their diseases. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.
Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.
Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Related Jobs
As a store associate, you'll be responsible for merchandising and stocking product, cashiering, and cleaning to keep the store looking its best. You'll enhance the customer shopping experience by work...
ALDI is looking for passionate and driven individuals to join our Store Manager Trainee program. In this role, you will develop the skills and knowledge necessary to lead your own store,deliveringouts...
As a store associate, you'll be responsible for merchandising and stocking product, cashiering, and cleaning to keep the store looking its best. You'll enhance the customer shopping experience by work...
When you join our team as an Assistant Store Manager, you'll take on key store management responsibilities including assisting with supervising day-to-day store activities, ensuring overall store perf...
ALDI is looking for enthusiastic part-time cashiers and stockers. As a cashier, you'll provide friendly, efficient checkout service, while as a stocker, you'll help keep shelves stocked and organized...
As a store associate, you'll be responsible for merchandising and stocking product, cashiering, and cleaning to keep the store looking its best. You'll enhance the customer shopping experience by work...
