Position Summary:

This is an opportunity for a highly motivated, entrepreneurial-spirited candidate to join our multidisciplinary team of engineers and scientists to enhance material characterization of commercial biopharmaceutical sterile liquids & suspension and oral solid dosage forms. The role is in the Manufacturing Science and Technology Department at our Wilmington, Ohio facility, centrally located within an hour's commute to the Cincinnati, Columbus, and Dayton metro areas.

Role Description:

• This individual will lead our material characterization capability supporting commercial product improvement projects and investigations. 
• Lead root cause and corrective action analysis; troubleshooting anomalies and failure analysis investigations are an essential function of this position.
• Contribute to identification of techniques that improve characterization of raw materials, process intermediates and products.

Key Tasks:

• Lead material characterization strategy, including project timelines, action plans, reports, presentations, and business updates for key stakeholders.
• Key projects include powder mechanical characterization, impact of raw materials on process, and impact of process on formulation.
• Key competencies include x-ray powder diffraction, thermal analysis, microscopy (optical & SEM), FT-IR spectroscopy, and powder characterization (e.g., PSD, flowability, density, compressibility).
• Evaluate, develop, and apply new characterization methodologies that enhance our product and process understanding.
• Design and perform experimental studies to support investigations and continuous improvement opportunities.
• Work collaboratively with MSAT engineers and scientists to enhance commercial product and process control.
• Support Regulatory post-approval updates.
• Write and disseminate technical data summaries and reports.

Education and Skills:

• Degree in Chemical Engineering, Pharmaceutical Sciences, Industrial and Physical Pharmacy, Material Sciences, Chemistry
• Ph.D.: Minimum 0-5 years’ experience in pharmaceutical development and manufacturing.

or

• MS: minimum 3+ years' experience in pharmaceutical development and manufacturing.
• BS: minimum 8+ years' experience in pharmaceutical development and manufacturing
• Research and/or industry experience demonstrating successful application of state-of-art characterization techniques supporting material characterization using one or more of the following: X-ray diffraction (XRD), thermal analysis (e.g., DSC, TGA, DVS), spectroscopic techniques (e.g., IR, Raman), and particle characterization (e.g., optical microscopy, SEM, particle size analysis, flowability, pycnometry).
• Good communication and project management skills for leadership of technical projects.
• Efficient in analyzing scientific data and openly discussing conclusions in non-confrontational peer reviews. Excellent analytical and written skills.
• Knowledge of PAT and cGMP pharmaceutical regulations is a plus.

 Physical Requirements:

• Must be able to work in an office and a manufacturing environment. 

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.