9 pharmaceutical jobs found in Wilmington

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. Job Summary The Senior Engineer, Oral Solid Dosage (OSD) Manufacturing Science and Technology (MSAT), serves as the process technical authority for critical OSD unit operations, with a primary focus on blending, tablet compression, and lowshear wet granulation via topdown spray fluid bed systems. This role is responsible for deep technical ownership of these processes across the product lifecycle, including commercial manufacturing support, technology transfer, troubleshooting, process optimization, and continuous improvement. The position partners closely with Manufacturing, Quality, Engineering, and Process Development to ensure robust, compliant, and capable processes that consistently deliver highquality product. The ideal candidate is a recognized subject matter expert (SME) who can translate scientific and engineering principles into practical, shopfloor solutions while maintaining strong regulatory and GMP alignment. Responsibilities Process...

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. 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 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. Director, Validation Overview Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, automation systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Responsibilities Development and oversight of site validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement. Responsible for preparation and management of side validation budget which includes clinical & commercial operations support and capital...