8 jobs found in Wilmington, OH

Alkermes, Inc. Working Hours: Days: Sunday, Monday, Tuesday, and every other Wednesday Hours: 5:00 AM - 5:00 PM Shift Type: 12-hour shifts GENERAL DESCRIPTION: An entry level technician position involving general maintenance and preventive maintenance activities under limited direct supervision intended to keep the facility and HVAC equipment (i.e. process HVAC units, comfort cooling, and process and HVAC chilled water/glycol systems) within operational specifications and safe. This position is part of a 24 hour/7day operation and may require assignment to a regular off shift and weekends schedule. 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. Accept ownership of...

Alkermes, Inc. Alkermes is currently seeking a temporary Researcher for our Manufacturing Sciences and Technology department, Analytical section. This position requires the individual to have laboratory experience in chemistry, biology, or pharmaceutical sciences with an emphasis on HPLC, UPLC, and GC instrumental techniques. This individual will be responsible for setting up and executing experiments such as LC assay, GC residual solvents, molecular weight determination, dissolution and in-vitro analyses, particle size and surface area determination. The Researcher is expected to coordinate sample testing, work efficiently, document results, and communicate findings in a timely manner. KEY RESPONSIBILITIES: Perform and record analyses. Adhere to GDP's in all work practices. Assist in maintaining a clean, safe workplace on a daily basis. Review peer's work as needed. Review revisions to procedures as needed. Assist with chemistry lab/product investigations and...

Alkermes, Inc. This position is based in Wilmington, OH We are seeking a qualified candidate for this position, which is available on both the 1st and 2nd shifts. While we will consider applicants for either shift, preference will be given to those available for 2nd shift. Summary: Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job Description: Read and follow detailed written SOP's/MPR's/Procedures. Document all work as required by cGMP's on a timely basis. Execute tasks as directed with...

Alkermes, Inc. 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...

Alkermes, Inc. Job Description - Engineer, Mechanical Responsible for supporting the growth and ongoing operation of the site facility as the technical owner of HVAC systems. Ensure the proper design and modification of HVAC systems to deliver the capability to consistently meet internal customer demands in a safe & compliant manner. Responsible for supporting the operation of the facility by assisting in troubleshooting /optimization of plant systems. This position will work closely with Project Management, Maintenance, Facility and Process System Owners, Site Operations, EHSS & Supply Chain to establish user requirements, discipline related strategies, assist with budgets, and key schedule milestones for project activities. Project activities are supported through a combination of matrixed and dedicated internal and external resources, and the position requires close and open communication with all parties including key stakeholders. Major Duties/Responsibilities:...

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....

Alkermes, Inc. This position reports to a Supervisor, Manufacturing. Position Summary: This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches. Essential Functions: The essential functions of this position include: Production, bulk packaging, and inspection of pharmaceutical drug formulations Assisting with facility cleaning and operational maintenance Cleaning all manufacturing equipment and areas Assisting with facility and process validations as required Assisting with environmental and water system monitoring as required Assisting with RCRA and safety inspections as required Documenting all work as required by cGMPs and GDPs on a timely basis Reading and following all Company SOPs and guidelines Abiding by all safety requirements as defined by the company Completing other tasks as assigned by supervision Preferred Qualifications: Basic...

Alkermes, Inc. Position Summary: The Lead Process Equipment Engineer is accountable for driving optimal equipment design, strategic reliability practices, and continuous improvement initiatives to consistently exceed customer expectations. Serves as the SME on process equipment and demonstrates deep functional knowledge of equipment operation across polymer, sterile, and oral solid dosage (OSD) pharmaceutical processes. Spearheads and contributes to continuous improvement projects aligned with commercial and clinical production needs. The role requires troubleshooting automated equipment, implementing equipment improvements, and ensuring compliance with regulatory documentation and operational protocols. This position will collaborate cross-functionally with teams such as, Engineering, Reliability, Manufacturing and Quality to strengthen equipment reliability and proactively mitigate supply chain risk. Job Description: Serve as Equipment Owner for key manufacturing...