Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads 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:
- Read and follow detailed written SOPs / Procedures
- Document all work as required by cGMPs on a timely basis.
- Executes tasks as directed with close attention to detail.
- Monitors Process 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.
- Other tasks as assigned by the Manager.
- Shift coverage and weekend work may be required.
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 gown in an aseptic manner for clean room operations.
Physical Requirements:
- Occasional periods of repetitive motion.
- Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
- Ability to operate all types of production equipment
- Ability to read, understand, and follow company SOP guidelines.
- Ability to lift/move up to 50 lbs. Ability to team lift up to 100 lbs.
- Ability to stand in steel-toed shoes for a minimum of 7 hrs.
Minimum Education & Experience Requirements:
Manufacturing Associate I
Basic Requirements
- High School diploma or equivalent.
Preferred Requirements
- 0-1 year experience in a sterile pharmaceutical operation preferred.
- Associate degree or higher in a science/technical discipline
Manufacturing Associate II
Basic Qualifications:
- High School Diploma or equivalent
- 1-3 years of pharmaceutical manufacturing or equivalent experience.
Preferred Qualifications:
- 1+ year experience in a sterile pharmaceutical operation
- Associate degree or higher in a science/technical discipline
Manufacturing Associate III
Required Education and Experience
- High School diploma or equivalent.
- 4-5 years of pharmaceutical manufacturing or equivalent experience
Preferred Education and Experience
- 2-3 years experience in a sterile pharmaceutical operation
- Associate degree or higher in a science/technical discipline
#LI-AH1
About Us
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 development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.