6 jobs found in Wilmington

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 is based in Wilmington, OH Hours: Sunday to Thursday 2300 to 0730 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 close attention to detail. Monitors process with close attention to detail. Follows Alkermes internal policies. Abide by all safety requirements as defined by the company....

Alkermes, Inc. The hours for this position would be 9:30 pm to 8:00 am, Monday through Thursday nights. 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...

Alkermes, Inc. Key Responsibilities Lead and supervise daily execution of tasks to support the published production plan, ensuring completion through Team Leads and Manufacturing Associates. Provide hands-on leadership, coaching, and feedback to production teams across all shifts. Ensure robust and timely communication of operational and planning activities. Support the Line Manager in fulfilling RACI responsibilities (Responsibility, Accountability, Consultation, Information). Drive, write, and approve new SOPs, batch records, and protocols for equipment and manufacturing processes. Interface with support groups (Maintenance, Engineering, Quality Assurance/Control, Planning, Warehousing, Process Development) to maintain operational status and support production schedules. Support quality investigations, continuous improvement, and engineering/maintenance/quality activities. Initiate and author investigations for process deviations, ensuring timely product release...

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...