Manufacturing Associate-Bulk (Shift to be determined)

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POST DATE 9/15/2016
END DATE 11/25/2016

Alkermes Wilmington, OH

Wilmington, OH
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Job Classification
Full Time
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Manufacturing Associate-Bulk

Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio. For more information, please visit Alkermes website at .

Perform all necessary operations activities manufacturing. These activities include, but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, Batch Processing, and Aseptic Manufacturing. Read and follows detailed written SOPs / Procedures, and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing, and review of cGMP documentation

Job Description :

R ead and follows detailed written SOPs / Procedures

Document all work as required by cGMPs on a timely basis.

Executes tasks as directed with close attention to deail

Monitors Process and with close attention to detail

Abide by all safety requirements as defined by the company.

Can work independently without constant supervision

Follows Alkermes internal policies

Works well in a team environment

Perform facility / equipment cleaning and set-up.

Assist with Development activities and Validation as required.

Perform aseptic operations.

Other tasks as assigned by Manager.

Shift coverage and weekend work may be required

Minimum Education & Experience Requirements:

2 year degree in a science/technical discipline (4 year degree preferred) and / or 3 years relevant manufacturing experience.

Knowledge/Skills Needed:

General math skills, including simple algebra.

General knowledge of and adherence to Current Good Manufacturing Practices.

General knowledge of HAZCOM, RCRA, and other Safety requirements.

Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment

General computer word processing/spreadsheet skills.

Good written communication

Excellent documentation skills.

Ability to lift / move 40lbs. overhead. Ability to team lift 100 lbs.

Ability to operate all types of production equipment (i.e. Rockwell HMI, CIP system, etc.).

Ability to gown in an aseptic manner for clean room operations.

Ability to read, understand and accurately follow company SOPs and guidelines.

Personal Attributes Needed:

Detail oriented

Willing to learn new tasks, skills.

Works well in a team environment.

Responds quickly to assignments.

Readily adapts to changing job duties.

Manages time well; ability to multi-task

Positive attitude.

Effective communication skills, written and verbal

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.