Manufacturing Associate I-1st Shift LMA

Alkermes; Cincinnati (OH); On-site; USD 35,000 - 50,000; Full time

Job summary

Join a leading company as a Manufacturing Associate I, performing critical operations related to recrystallization and micron-suspension. Responsibilities include adhering to GMP standards, documenting processes, and collaborating within a team. Ideal candidates have a high school diploma and basic math skills, with experience in sterile pharmaceutical operations preferred.

Qualifications

• 0-1 year experience in sterile pharmaceutical operations preferred.
• 1-3 years of pharmaceutical manufacturing or similar experience preferred.

Responsibilities

• Read and follow detailed written SOPs / Procedures.
• Document all work as required by cGMPs.
• Execute tasks with close attention to detail.

Skills

Basic math skills

Knowledge of GMP standards

Mechanical aptitude

Computer skills

Strong written communication

Education

High School diploma or equivalent

Associate degree or higher in science/technical discipline

Job description

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Hours:

This position works Monday to Thursday from 6:00 AM to 4:30 PM.

Job Description

Summary: Perform all necessary operations activities related to recrystallization and micron-suspension. These activities include but are not limited to: batch records, operating procedures, equipment manuals, various specifications, cleaning, sterilization, filtering, transferring materials aseptically, and other GMP-related tasks. Additional responsibilities include SOP writing and reviewing GMP documentation.

Responsibilities:

• Read and follow detailed written SOPs / Procedures
• Document all work as required by cGMPs on a timely basis
• Execute tasks with close attention to detail
• Monitor process operations carefully
• Abide by all safety requirements as defined by the company
• Work independently without constant supervision
• Follow Alkermes internal policies
• Collaborate effectively within a team environment
• Perform facility and equipment cleaning and setup
• Assist with development activities and validation as needed
• Perform other tasks as assigned by the manager
• Shift coverage and weekend work may be required

Knowledge and Skills:

• Basic math skills, including simple algebra
• Knowledge of and adherence to current GMP standards
• Understanding of HAZCOM, RCRA, and safety requirements
• Mechanical aptitude for minor equipment adjustments and troubleshooting
• Computer skills in word processing and spreadsheets
• Strong written communication and documentation skills
• Ability to gown aseptically for clean room operations

Physical Requirements:

• Repetitive motion as needed
• Walking, lifting, pushing, pulling, reaching, climbing, bending
• Operate all types of production equipment
• Read and follow SOP guidelines
• Lift/move up to 50 lbs; team lift up to 100 lbs
• Stand in steel-toed shoes for at least 7 hours

Minimum Education & Experience:

Manufacturing Associate I:

• High School diploma or equivalent

Preferred:

• 0-1 year experience in sterile pharmaceutical operations
• Associate degree or higher in science/technical discipline

Manufacturing Associate II:

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

Preferred:

• Over 1 year experience in sterile pharmaceutical operations
• Associate degree or higher in science/technical discipline

Manufacturing Associate III:

• High School diploma or equivalent
• 4-5 years of pharmaceutical manufacturing or similar experience

Preferred:

• 2-3 years experience in sterile pharmaceutical operations
• Associate degree or higher in science/technical discipline

About Us

Why join Team Alkermes? Alkermes applies deep neuroscience expertise to develop medicines for psychiatric and neurological disorders. Headquartered in Ireland with U.S. locations, we are committed to innovative science and compassionate care. Our portfolio includes treatments for alcohol and opioid dependence, schizophrenia, bipolar disorder, and more. We foster a diverse, inclusive culture and have received multiple recognitions as an employer of choice.

Alkermes is an equal opportunity employer and complies with all applicable laws and regulations, including E-Verify.