13 jobs found in Wilmington, OH

Alkermes, Inc. 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. MAJOR RESPONSIBILITIES Major Responsibility Percentage of time spent on each responsibility 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 40% Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) 35% Enumerate organisms on cultured media for environmental monitoring and utility samples. 15% Review of routine paperwork 5% Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab...

Alkermes, Inc. Overview: The Quality Control Supervisor oversees the daily operations of a group of analysts, sets clear objectives around the execution and delivery of the QC work load. The Supervisor works cross-functionally with QC management and leaders of other departments to support the commercial release of raw materials and finished products. The supervisor also ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The supervisor is responsible for scheduling personnel and material resources to ensure that testing commitments are satisfied and communicate any difficulties to QC management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor Measures progress, evaluates results, and takes responsibility for outcomes. Responsibilities: Supervise testing to ensure compliance with all applicable procedures, 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. 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. POSITION SUMMARY The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, act as point person on CMC Teams and validation projects. Responsibilities will also include reviewing, reporting test results as related to validation protocols. Direct Support for Method development and optimization for all Microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, Bioburden. Suggest and implement new technologies and equipment for Microbiological testing. QUALIFICATIONS A four year degree in science, preferably in Biology or Microbiology with minimum 8 years' experience in the pharmaceutical industry Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters Critical thinker,...

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...

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...