Alkermes

Summary

This position will support and assist in manufacturing pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to the production facility, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes. Develop and implement SOPs in support of new and upgraded processes. Champion projects as they move into and through the manufacturing areas. Provide regular updates to leadership on project status and issues.

Essential Functions

• Troubleshoot and maintain manufacturing systems, processes, and equipment.
• Support the development or transfer of manufacturing and cleaning processes for the manufacturing area.
• "Hands-on" ability to install and troubleshoot instrumentation and equipment.
• Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
• Specify and size manufacturing systems, equipment, and process equipment.

Competencies

• Excellent communication and documentation skills
• Excellent organizational skills
• Ability to self-manage and prioritize workload.
• Ability to react quickly to understand and solve problems.
• Excellent troubleshooting skills
• Fosters collaborative relationships within and across groups through influencing and negotiation skills
• Positive attitude

Process Engineer I

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 0-2 year of manufacturing experience or technical experience.

Preferred Qualification:

• 0-2 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience.
• Experience with OSD equipment procurement.
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
• Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up.
• Knowledge of OSD pharmaceutical process and equipment validations.
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc

Process Engineer II

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 2-5 year of manufacturing experience or technical experience.

Preferred Qualification:

• 2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience.
• Experience with OSD equipment procurement.
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
• Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up.
• Knowledge of OSD pharmaceutical process and equipment validations.
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc

Lead Engineer I

Basic Qualifications:

• BS degree in Engineering or technical discipline.
• 5+ year of manufacturing experience or technical experience.

Preferred Qualification:

• 5+ years of OSD pharmaceutical experience.
• Experience with OSD equipment procurement.
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
• Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up.
• Knowledge of OSD pharmaceutical process and equipment validations.
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc

Work Environment

Work will be split between the contained manufacturing area and the office.

Physical Demands

• Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
• Ability to lift/move 40 lbs. overhead. Ability to team lift up to 100 lbs.
• Must be able to be medically cleared for respirator use (PAPR)
• Ability to operate different types of production equipment.
• Ability to gown correctly for clean room manufacturing operations.
• Ability to stand or sit for extended periods (up to 2 hours at a time).
• Must be able to work in an office and a manufacturing environment.

Travel

<10%.

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

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.