Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
Under the direction of the Supervisor, the Oral Solid Dose (OSD) manufacturing (MFG) associate is responsible for all activities related to the manufacturing of clinical and commercial batches of OSD drug product, including blending, milling, compression and coating. The MFG associate is responsible for adhering to safety procedures, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) for pharmaceutical products. They will assist with facility and equipment cleaning and operational maintenance, process and cleaning validations, environmental and water system monitoring, and other tasks as assigned.
Key Duties include: Operates manufacturing equipment independently, as well as part of a team. Cleans and maintains the manufacturing area and equipment. Actively participates in the continuous improvement of procedures and processes. Monitors the process, makes observations and reports any abnormal conditions to the supervisor/manager. Complies with company policies and procedures, and maintains regular work attendance. Personal responsibility for following safety rules, SOPs and cGMP guidelines. Performs other duties as assigned.
Minimum Education & Experience Requirements:
High school diploma or equivalent.
Previous manufacturing experience.
2-5 years experience in OSD pharmaceutical manufacturing.
Previous experience working with DEA controlled substances and highly potent compounds preferred.
Ability to communicate clearly. Must be able to respond to and precisely follow verbal and written instructions. Basic knowledge of the Scientific Method. Basic math skills, including simple algebra. Basic knowledge of and adherence to current GMP desired. Basic knowledge of chemistry and biology beneficial. Basic knowledge of HAZCOM, RCRA and other Safety requirements. Basic level of mechanical aptitude. Good documentation skills. Ability to lift / move 50 lbs. overhead. Physical ability to repetitively lift, stand, climb, bend, etc. within a manufacturing environment. Ability to learn how to operate all types of production equipment (I.e. Honeywell DCS panels, CIP system, Process Waste system, etc.). Ability to read, understand and accurately follow company SOPs and guidelines.
Personal Attributes Needed:
Detail oriented. Self motivated and willing to learn new tasks and skills. Works well in a team environment. Responds quickly to assignments. Readily adapts to changing job duties. Positive attitude. Displays understanding of and promotes company and customer objectives.
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.
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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.