Manufacturing Associate I

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.

Manufacturing Associate-Bulk-Days

Summary

Entry level position for persons to manufacture commercial scale batches.

Essential Functions

• Production, filling and inspection of pharmaceutical formulations.
• Assist with facility cleaning and operational maintenance.
• Assist with facility and process validations as required.
• Perform aseptic production operations and validations.
• Aseptic qualifications consist of passing gown qualification, maintaining gown access, passing Grade A qualifications, passing media fill qualifications, and perform Environmental monitoring during aseptic filling. Performance include:
• Assist with environmental monitoring, performing settle plate change out and air monitoring in the Grade A Zone, handset monitoring, and personnel gowning monitoring. For operators performing environmental monitoring, the qualification process includes on the job training and then performing settle plate and active viable air placement with qualified operators during batch. 
• Performing critical interventions in the Grade A zone. Interventions performed by qualified operators in an aseptic processing area where sterile product, product components or product contact surfaces are exposed.
• Following aseptic technique rules such as minimize talking in clean rooms and pass throughs, minimize motion and traffic flow in clean rooms, fast, erratic motions increase turbulence and particulate shedding, walk slowly; keep arms and hands away from body, care should be taken while working in critical areas not to come in contact with sterile surfaces or exposed product, ensure that non-sterile equipment or body parts do not impede the laminarity of air flow above sterile surfaces or exposed product, frequently sanitize gloves.
• Never lean directly over the work surface in a vertical laminar flow zone or hood.
• Avoid touching the face with gloved hands. If goggles or mask need to be adjusted or changed, enter clean side of gowning room and fix or replace. Remove gloves, sanitize, and re-place with new gloves. (Reference SOP 110-01452)
• Handle any and all items only if necessary.  Avoid touching walls, doors, electrical switches, phones, or any other possible source of contamination. Use elbow/palm to open doors where handles allow.
• Before entering the critical zone, sanitize hands with IPA by touching the spray nozzle only. Allow hands to air dry before entering the zone.
• A general contamination control course will be taught by QC Microbiology and will cover the basics of how and why we need to control microorganisms in controlled rooms. It will also cover sources of clean room contamination, contamination control, cleaning and sanitization, and personnel conduct in clean rooms. This training will occur once per calendar year for qualified personnel with clean room access.
• Assist with clean room sanitization as required.
• Assist with RCRA and safety inspections as required.
• Document all work as required by CGMPs on a timely basis.
• Read and follow all Company SOPs and guidelines.
• Abide by all safety requirements as defined by the company.
• Other tasks as assigned by team leader.

Required Education and Experience

• High School diploma or equivalent.
• 0-1 years’ experience in Manufacturing

Preferred Education and Experience

• 0-1 years’ experience in a sterile pharmaceutical operation

Competencies

• Basic knowledge of the Scientific Method
• Basic math skills, including simple algebra
• Basic knowledge of and adherence to current GMP.
• Basic knowledge of chemistry and biology.
• Basic knowledge of steam/dry heat sterilization theories.
• Basic knowledge of HAZCOM, RCRA and other Safety requirements.
• Basic level of mechanical aptitude.
• Good documentation skills.
• Ability to learn how to operate all types of production equipment (I.e. Autoclave, Dry Heat Oven, etc.).
• Ability to read, understand and accurately follow company SOPs and guidelines.
• Detail oriented.
• Willing to learn new tasks, 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.

Physical Demands

• Ability to lift / move 40 lbs. overhead

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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