Alkermes

Job Summary: The Manufacturing Science and Technology Engineer will be critical in supporting the manufacturing processes of oral solid dosage forms. This position involves ensuring efficient and compliant production, troubleshooting technical issues, and driving continuous improvement initiatives.

Key Responsibilities:

• Process Support: Provide technical support for the manufacturing of oral solid dosage forms, ensuring processes are efficient, compliant, and meet quality standards.
• Technology Transfer: Collaborate with cross-functional teams to facilitate the transfer of new processes and products into commercial manufacturing.
• Troubleshooting: Identify and resolve technical issues related to equipment, processes, and materials to minimize production downtime.
• Continuous Improvement: Lead and participate in continuous improvement projects to enhance process efficiency, product quality, and cost-effectiveness.
• Documentation: Author and review technical documents, including batch records, standard operating procedures (SOPs), and technical reports.
• Compliance: Ensure all manufacturing activities comply with regulatory requirements, Good Manufacturing Practices (GMP), and company policies.
• Data Analytics: Analyze process data to identify trends, optimize processes, and support decision-making.
• Collaboration: Work closely with Manufacturing, Quality Assurance, Quality Control, Supply Chain, Process Development and other departments to ensure seamless operations and new improvement/technology installation.

Qualifications:

• Education: Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field.
• Experience: Minimum of 5-10 years of experience in pharmaceutical manufacturing, with a technical focus on oral solid dosage forms.
• Technical Skills: Strong understanding of OSD manufacturing processes, equipment, and technologies. Proficiency in data analysis and process optimization. Familiarity with JMP stats software and coding in JSL, SQL, JAVA, HTML, and/or Python is desired.
• Problem-Solving: Excellent troubleshooting and problem-solving skills.
• Communication: Strong written and verbal communication skills. Ability to work effectively with both technical and non-technical teammates.
• Regulatory Knowledge: Familiarity with GMP, FDA regulations, and other relevant industry standards.

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.