Designs and executes experimental studies to develop well understood, robust oral solid dosage manufacturing processes. Key duties are process design, equipment set-up, troubleshooting process and / or equipment, running experiments, collecting, and evaluating data to identify and implement process/equipment improvements reducing waste and increasing process reliability. 

 Responsibilities:

• Design and execute process development activities focused on developing well understood, science driven products and processes at all scales resulting in robust and repeatable control. Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved. 
• Lead process risk assessments.
• Sound understanding of the operation of processing equipment with ability to set up equipment and run the process independently and / or with help of technician. 
• Required to assimilate and use new technologies quickly and provide guidance, training, and direction on technical items. 
• Manufacture GMP batches at various scales to support phase appropriate clinical supplies.
• Readiness to support the expansion, set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and OSD process and new technology approaches.
• Support qualification, calibration and maintenance of new equipment and instruments. 
• Author /review master batch records, protocols and reports. 
• Author CMC sections for IND, NDA, and other regulatory filings. 
• Author /review change controls, SOPS, deviations and associated CAPAs
• Maintain compliance with all aspects of cGMP, safety and environmental legislation and company policy, which impacts on day-to-day activities.
• Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
• Manage, train and mentor technician or junior process development staff.
• Perform other duties as assigned.

Qualifications and Requirements:

• Bachelor’s Degree with 8+ years or 
• Master’s Degree with 5+ years of experience in engineering/pharmaceutical /scientific discipline, or the equivalent in pharmaceutical product development environment. 
• Thorough understanding of the pharmaceutical solid oral unit operations. Capable of independently planning the experiments, presenting and interpreting the data and statistical data analysis. 
• Prior experience in working in a cross functional team environment is highly preferred. Ability to identify, highlight and communicate the issues and risk to the senior management. Technical problem-solving ability, gap assessment and offer risk mitigation strategies. 
• Excellent presentation, written and communication skills. Prior experience in writing the process development reports, MBRs, protocols and CMC regulatory documents is required. 
• Mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment. "Hands-on" ability to install and troubleshoot instrumentation and equipment. Understanding of the drug development process and the role and impact of process development within this process. 
• Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
• Understanding of ICH, FDA, SUPAC and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
• Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
• Previous experience with process analytical technology (PAT) and drug product formulation is preferred.

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About Us

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.