Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland , Alkermes plc has an R&D center in Waltham, Massachusetts ; a research and manufacturing facility in Athlone, Ireland ; and a manufacturing facility in Wilmington, Ohio . For more information, please visit Alkermes' website at www.alkermes.com .
Job Description:
Support and assist in the manufacture of pharmaceutical products for commercial and clinical supplies. Scale-up and transfer formulations/processes to production facility, design and recommend equipment purchases, write and execute qualification/validation protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control system) to reduce waste and increase process reliability. Support of manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to, but not limited to, Operability, Technical accuracy (technical reviews), Compliance, Process Robustness. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes, Write or revise SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel, Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Develop and implement SOPs in support of new and upgraded processes, Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades, Represent manufacturing on process design teams, Champion projects as they move into and through the manufacturing areas, Provide regular updates to manufacturing management on the status and issues involved in projects.
Minimum Education & Experience Requirements:
BS degree in Engineering. 1-2 years sterile pharmaceutical experience, or 5+ yrs pharmacuetical engineering experience. Experienced working on (and coordination of) multiple projects in an orderly and efficient manner; while consistently meeting established deadlines; Experienced in working successfully across functions to meet company objectives.
Knowledge/Skills Needed:
Personal Attributes Needed:
Physical Requirements:
Ability to lift / move 40lbs. overhead. Ability to team lift up to 100 lbs. Ability to operate all types of production equipment. Ability to gown correctly for clean room manufacturing operations. Ability to read, understand and accurately follow company SOPs and guidelines. Ability to stand or sit for extended periods of time (up to 2 hours at a time). Must be able to work in office and manufacturing environment. Some travel required (< 10%). May require occasional off-shift and/or weekend support (< 10%).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
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Experience Level:
Associate
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