11 jobs found in Wilmington, OH

Alkermes, Inc. Engineering leadership position for degreed Engineer/Manager with experience in pharmaceutical operations and knowledge of facility equipment/utilities. Position has responsibility for supervising/directing internal engineering resources, as well as contract service providers, to ensure business objectives are met and site facilities, utilities and equipment meet business requirements in a safe and compliant manner. Responsibilities KEY DUTIES: Ensure engineering department resources are responsive and effective in meeting the tactical and strategic needs of the site. Development and implementation of process and reliability improvement projects. Provide oversight to relationships with key vendors, A&E firms and engineering service providers. Ensure good project management practices are applied within department. Assist maintenance and manufacturing with systems operation, preventive maintenance, and specification and procurement of replacement...

Alkermes, Inc. Day Shift- Sunday, Monday, Tuesday, and every other Wednesday, 6 am to 6 pm A technician position involving general maintenance and preventive maintenance activities under minimal direct supervision, intended to keep the facility and electrical distribution systems within operational specifications and safe. This position is part of a 24 hour/7 day operation and may require assignment to a regular off shift and weekends schedule. Responsibilities KEY DUTIES: Perform PM's Follow Written Preventative Maintenance Procedures Accurately complete maintenance paperwork, including work orders and logbooks. Review and update maintenance procedures based on field experience. Review and update drawings to reflect as built conditions. Identify opportunities for improving PM program. Recommend changes to PM program based on experience with equipment and analysis of historical data. Accept ownership of selected equipment and serve as the point person...

Alkermes, Inc. Temp QC Analyst-EM POSITION SUMMARY The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Responsibilities REPSONSIBILITIES Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) Enumerate organisms on cultured media for environmental monitoring and utility samples. Review of routine paperwork Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc. Qualifications QUALIFICATIONS Ability to work hard and contribute to an enjoyable working...

Alkermes, Inc. Temp QC Analyst-EM POSITION SUMMARY The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Responsibilities REPSONSIBILITIES Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) Enumerate organisms on cultured media for environmental monitoring and utility samples. Review of routine paperwork Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc. Qualifications QUALIFICATIONS Ability to work hard and contribute to an enjoyable working...

Alkermes, Inc. POSITION SUMMARY The Warehouse Associate handles receipts from carriers, unpacks and checks the condition and content of deliveries against purchase orders and packing slips, and distributes materials to end users. This individual will coordinate corrections of shipment errors through Purchasing. Other duties may be assigned by the Manager. Responsibilities MAJOR RESPONSIBILITIES Ensuring the security, tracking, and accountability of materials and goods required for inventory control of controlled and non-controlled items. Data input into the SAP system for receiving / shipping of controlled /non-controlled and DEA Controlled Materials, quarantining materials, and transferring material to and from Manufacturing into released materials and shipments. Physical and administrative tasks involved in the shipping, receiving, storage, and distribution of materials for all departments. Maintain adherence to established protocols and applicable SOPs for shipping...

Alkermes, Inc. POSITION SUMMARY The Warehouse Associate handles receipts from carriers, unpacks and checks the condition and content of deliveries against purchase orders and packing slips, and distributes materials to end users. This individual will coordinate corrections of shipment errors through Purchasing. Other duties may be assigned by the Manager. Responsibilities MAJOR RESPONSIBILITIES Ensuring the security, tracking, and accountability of materials and goods required for inventory control of controlled and non-controlled items. Data input into the SAP system for receiving / shipping of controlled /non-controlled and DEA Controlled Materials, quarantining materials, and transferring material to and from Manufacturing into released materials and shipments. Physical and administrative tasks involved in the shipping, receiving, storage, and distribution of materials for all departments. Maintain adherence to established protocols and applicable SOPs for shipping...

Alkermes, Inc. The Process Development Technician supports the execution of experimental and clinical studies to develop well-understood, robust oral solid dosage (OSD) manufacturing processes. Key responsibilities include execution of experiments, documentation and data collection to support process development. This role plays a key part in maintaining GMP standards and supporting the manufacture of development and clinical supplies. Responsibilities Assist in designing experimental programs and compiling data from studies. Execute experiments to enhance process understanding and manufacture GMP clinical batches at various scales. Complete all documentation accurately and legibly, ensuring compliance, and participate in updating batch paperwork and SOPs. Maintain a working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required. Maintain awareness of project schedules and strive to achieve...

Alkermes, Inc. Support preventive action, development, engineering, and ongoing manufacturing efforts regarding quality and efficiency. Responsibilities Monitor active manufacturing batches, process trends, and floor activities to ensure safe, compliant, and efficient fill/finish operations. Provide real-time technical support and troubleshooting of batch issues, equipment concerns, and process deviations. Lead and support continuous improvement initiatives and change control activities. Support and/or lead non-routine on-the-floor activities including engineering studies, proof-of-concept runs, equipment testing, and safety improvements. Act as a manufacturing liaison with project Planning, Engineering and Technical teams. Develop and maintain process monitoring and trending tools; perform periodic review of data to identify opportunities to improve performance and efficiency Identify unfavorable trends, investigate root causes, and support the development and...

Alkermes, Inc. The Senior Systems Analyst role will drive the design, deployment, and support of manufacturing computer systems and integrated equipment at the Alkermes Wilmington facility. The successful candidate will build strategic business partnerships, drive business value, and foster a culture of innovation and compliance. Responsibilities Oversee and support the implementation and lifecycle management of vendor integrated & skidded equipment and other manufacturing computer systems. Design, deploy, and maintain computer systems and supporting infrastructure to meet manufacturing, compliance, and reliability requirements. Serve as a subject matter expert for assigned technical systems. Partner with crossfunctional teams including Operations, Engineering, Validation, Quality and Facilities to ensure system accuracy, data integrity, business continuity, and alignment with operational needs. Troubleshoot and resolve complex hardware, software, and...

Alkermes, Inc. Associate Director, External Operations API API process expert responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations' (CMO's) and subsequent processing of API's in Drug Product (DP) processes across OSD and injectables. Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO's on behalf of Alkermes. Responsibilities General Review and maintain Alkermes practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements - ensuring that appropriate policies, rules, regulations and agreements are followed. Understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities. Perform trending on CMO API processes and identify...

Alkermes, Inc. 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....