Alkermes

Job Summary:

Support and assist in manufacturing pharmaceutical products for commercial and clinical supplies. Scale up and transfer formulations/processes to production facility, design and recommend equipment purchases, write and execute qualification/validation protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing a Change Control system) to reduce waste and increase process reliability. Support of manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regard to, but not limited to, Operability, Technical accuracy (technical reviews), Compliance, Process Robustness. Perform process and equipment evaluation (FMEA, etc.) to identify risks and weaknesses in new and current processes, Write or revise SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel, Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Develop and implement SOPs in support of new and upgraded processes. Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades. Represent manufacturing on process design teams. Champion projects as they move into and through the manufacturing areas. Provide regular updates to manufacturing management on project status and issues.

Knowledge/Skills Needed:

• Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as parenteral drug process systems and equipment.
• Thorough knowledge of automated control systems.
• Thorough knowledge of computer systems operation and software.
• Thorough knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
• Thorough knowledge of chemistry, statistics, equipment design, process control, and process scale-up.
• Knowledge of sterile pharmaceutical operations and equipment validations.
• "Hands-on" ability to install and troubleshoot instrumentation and equipment.
• Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
• Ability to author high-quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS).
• Ability to specify and size manufacturing systems, equipment, and process equipment.
• Ability to gown in an aseptic manner for clean room operations.
• Ability to read, understand, and accurately follow company SOPs and guidelines.
• Demonstrated ability to deal effectively across multiple functional departments in a matrixed product team structure.
• Presentation abilities to technical and management teams
• Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc.
• Adaptable to changing priorities.

Personal Attributes Needed:

• 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.
• Positive attitude.
• Fosters collaborative relationships within and across groups through influencing and negotiation skills
• Logical problem-solving skills
• Effectively manage conflict and differences of opinion
• Ability to operate all types of production equipment.

Physical Requirements:

• Prolonged periods of sitting or standing.
• Periods of repetitive motion
• Walking, squatting, lifting, pushing, and pulling carts, reaching, climbing, and bending may all be required.
• Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed.
• Employee must be able to pass a vision exam before employment.
• Aseptic gowning must be maintained, including an annual requalification.

Basic Qualifications:

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

Preferred Qualification:

• 5+ years of Sterile pharmaceutical experience.
• Experience with Parts Washers, Autoclaves, Vial Washers, Fillers, Cappers, and Compounding.
• Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
• Thorough knowledge of aseptic operations, statistics, equipment design, process control, and process scale-up.
• Knowledge of aseptic pharmaceutical process and equipment validations.

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.