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Manufacturing Process Technologist

3 months ago

Wilmington, United States Alkermes Full time

Job DescriptionIn the assigned manufacturing area, directly supports the Vivitrol formulation manufacturing process. Actively supports on-going manufacturing efforts in terms of quality and efficiency, provides an interface with Development and Engineering in technology transfer of new processes as well as process upgrades to existing technologies, and provides support to Corrective and Preventive Action programs. Conducts real-time monitoring/trending of manufacturing processes and finished product analytical data.ResponsibilitiesDevelops and maintains databases which provide trending capability for process parametersDevelops and maintains (tracks) Vivitrol production metrics through use of analytical toolsConducts frequent and thorough periodic reviews of database and trends, identify opportunities for improvement in performance both in process, manpower effectiveness and efficiencyActively identifies unfavorable trends and investigates root cause as well effective preventive actionsProvides leadership and manufacturing support in investigations, as assignedAssures the resolution of deviations, corrective actions, Change Control action items, and any audit non-compliance itemsEnsures the timely completion of assigned deviations and CAPAsPerforms process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processesWrites/revises, develops and implements SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnelEstablishes familiarity with all manufacturing activities involved in the sterile production process to share best practices and streamline operationsDevelops and implements effective training of manufacturing personnel related to technical transfer and process upgradesActs as a manufacturing liaison in project planning and coordinationRepresents manufacturing on process design teamsChampions projects as they move into and through the manufacturing areasAuthors, drives, and assures accurate and timely execution of process Change Controls; Partners with other bulk groups, when necessaryProvides regular updates to manufacturing management on the status and issues involved in projectsPerforms troubleshooting of issues and non-conformance itemsProvides administrative support to manufacturing in authoring and reviewing engineering/validation documentation, as assignedSupports manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to (but not limited to): Operability, Technical accuracy, Compliance, and Process RobustnessSupports production of pharmaceutical formulationsMaintains individual training proficiency; Trains operators on processesDocuments all work as required by cGMPs on a timely basisAbides by all safety requirements as defined by the companyAssists with RCRA and safety inspections, as requiredOther tasks as assigned by managementWorking conditions will be a mix of office work and on-the-floor (cleanroom) production support. May require occasional off-shift and/or weekend support (< 10%)QualificationsEDUCATION AND EXPERIENCE:Manufacturing Process TechnologistBasic ExperienceBS Degree or equivalent experience1-2 years in manufacturing, process development, or engineering in a pharmaceutical settingPreferred ExperienceBS Deegree in Engineering, Chemistry or BiologyExperienced working on (and coordination of) multiple projects in an orderly and efficient manner, while consistently meeting established deadlinesExperienced in working successfully across departments to meet company objectivesSr. Manufacturing Process TechnologistBasic ExperienceBS Degree or equivalent experience5+ years in manufacturing, process development, or engineering in a pharmaceutical settingPreferred ExperienceBS Deegree in Engineering, Chemistry or BiologyExperienced working on (and coordination of) multiple projects in an orderly and efficient manner, while consistently meeting established deadlinesExperienced in working successfully across departments to meet company objectivesSKILLS/ABILITIES:Ability to lift/move 50lbs. overhead; Ability to team-lift 100 lbs.Ability to operate all types of production equipmentAbility to self-manage and prioritize work loadAbility to gown properly for clean room operationsAbility to read, understand and follow company SOPs and guidelinesAbility to stand or sit for extended periods of time (up to 2 hours at a time)Strong knowledge of pharmaceutical manufacturing processesWorking knowledge of Good Manufacturing Practices (US and EU)Ability to quickly understand detailed and complex processesComputer proficiency with JMP, Microsoft Word, Excel, PowerPointMust be able to work in office and manufacturing environmentSome travel required (< 10%)PERSONAL ATTRIBUTES:Dependable, well-organized, efficientDetail and results orientedMotivated self-starter; Willing to learn new tasks, skillsWorks well in a team environmentStrong oral and written communication skillsResponds quickly to assignments; Readily adapts to changing job dutiesManages time well; Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlinesAbility to work cross-functionally to meet company objectivesPositive attitude; Displays understanding of and promotes company objectivesAbout UsWhy join Team Alkermes? Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.