Manufacturing Associate-Filling

Overview

JOB DESCRIPTION

This position is based in Wilmington, OH. This role is available on both the 1st and 2nd shifts; preference will be given to candidates available for 2nd shift.

Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. Activities include equipment cleaning/assembly/setup, equipment operation, and batch processing. Read and follow detailed written SOPs/MPRs with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform area sanitizations as needed. Maintain individual training proficiency through the Learning Management System.

• Read and follow detailed written SOPs/MPRs/Procedures.
• Document all work as required by cGMPs on a timely basis.
• Execute tasks as directed with close attention to detail.
• Monitor processes with close attention to detail.
• Follow Alkermes internal policies.
• Abide by all safety requirements as defined by the company.
• Perform aseptic gowning and maintain gowning qualification (including wearing of hood, coverall, boots, mask, goggles, gloves).
• Perform clean room sanitizations.
• Perform equipment prep/assembly/setup.
• Operate equipment used in filling of microspheres/suspensions/liquid products.
• Assist with development and validation activities as required.
• Other tasks as assigned by Manager.
• Shift coverage and weekend work may be required.

• General knowledge of aseptic fundamentals.
• General math skills, including using metric weight system.
• General knowledge and adherence to Current Good Manufacturing Practices.
• General knowledge of HAZCOM, RCRA, and other safety requirements.
• Good mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.
• General computer skills.
• Excellent documentation skills.

• Positive attitude
• Integrity/Ethics
• Adaptability/Flexibility
• Dependability
• Detail-oriented
• Self-motivated
• Responds quickly to assignments
• Works well in a team environment
• Adapts well to changing job duties
• Takes ownership and is willing to learn new tasks/skills

• Occasional periods of repetitive motion.
• Aseptic gowning must be maintained, including an annual requalification.
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may be required.
• Ability to operate all types of production equipment (e.g., Rockwell HMI, autoclaves).
• Ability to read, understand, and accurately follow company SOPs and guidelines.
• Ability to lift/move up to 50 lbs. overhead. Team lifting up to 100 lbs.
• Ability to stand in steel-toed shoes for a minimum of 7 hours.

• High School diploma or equivalent.

• 0-1 year of experience in a sterile pharmaceutical operation.
• Associates degree or higher in science/technical discipline.

• High School diploma or equivalent.
• 1-3 years of pharmaceutical manufacturing or equivalent experience.

• 1+ year in a sterile pharmaceutical operation.
• Associates degree or higher in science/technical discipline.

• High school diploma or equivalent.
• 4-5 years of pharmaceutical manufacturing or equivalent experience.

• 2-3 years of experience in a sterile pharmaceutical operation.
• Associates degree or higher in science/technical discipline.

Why 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…