Manufacturing Associate I-OSD 3rd Shift

Alkermes; Wilmington (DE); On-site; USD 42,000 - 60,000; Full time

Job summary

Alkermes is seeking an entry-level Manufacturing Associate to join a small team in a GMP environment, producing commercial and/or clinical-scale batches. The role supports production, packaging, and routine inspections while ensuring adherence to cGMPs and GDPs.

The position requires basic knowledge of GMPs, chemistry, and biology, with a readiness to learn production equipment and SOPs. Availability for various shifts and a collaborative team mindset are essential.

Qualifications

• High School diploma or equivalent required.
• Basic knowledge of GMPs and GDPs.
• Ability to operate production equipment and follow SOPs.
• Willingness to learn and work in a team environment.

Responsibilities

• Produce, bulk packaging, and inspect pharmaceutical drug formulations.
• Assist with facility cleaning and operational maintenance.
• Clean all manufacturing equipment and areas.
• Assist with facility and process validations as required.
• Environmental and water system monitoring as required.
• RCRA and safety inspections as required.
• Document all work per cGMPs and GDPs.
• Read and follow Company SOPs and guidelines.
• Abide by safety requirements and assist with other tasks as assigned.

Skills

Scientific Method

GMPs & GDPs

Chemistry & Biology basics

Safety knowledge

Teamwork

Documentation

Education

High School diploma or equivalent

Bachelor's degree preferred; other relevant work experience

Science/technical degree

Tools

Microsoft Suite

SAP

Veeva Vault

LMS

Job description

This position reports to a Supervisor, Manufacturing. The hours of this position are Monday to Thursday, 9:30pm to 8:00am

Position Summary:

This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

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.

Preferred Qualifications:

• Basic knowledge of the Scientific Method
• Basic math skills including addition, subtraction, multiplication, division, and percentages
• Basic knowledge of and adherence to current GMPs and GDPs
• Basic knowledge of chemistry and biology
• 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. Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils, etc.)
• Ability to read, understand, and accurately follow company SOPs and guidelines
• Basic knowledge of computer systems (Microsoft Suite, SAP, Veeva Vault, LMS)
• Understanding and comprehension of Master Batch Records
• Detail-oriented
• Willingness to learn new tasks and skills
• Ability to work well in a team environment
• Ability to respond quickly and execute assignments
• Willingness to readily adapt to changing job duties
• Positive attitude
• Understanding of and promotion of company and customer objectives
• Ability to follow all procedures to ensure a high-quality product

Education and Experience:

Manufacturing Associate I

Basic Qualifications:

• High School diploma or equivalent

Preferred Qualifications:

• 0-1 years of experience in a pharmaceutical manufacturing operation, preferably in OSD
• A bachelor's degree is preferred; other relevant work experience, education, and training will be considered.

Manufacturing Associate II

Basic Qualifications

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

Preferred Qualifications

• 1+ year experience in OSD Manufacturing
• Associate degree or higher in a science/technical discipline
• Other relative work experience, education, and training will be considered

Manufacturing Associate III

Basic Qualifications

• High School diploma or equivalent
• 4-5 years of experience in a pharmaceutical manufacturing operation.

Preferred Qualifications

• 2-3 year experience in OSD Manufacturing
• Associate degree or higher in a science/technical discipline
• Other relative work experience, education, and training will be considered

Working Conditions:

Available for any shift with the possibility for overtime (as necessary)

Physical Requirements:

• Ability to push and/or pull equipment or product using a pallet jack
• Ability to lift/move 40 lbs. overhead.
• Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
• Must be able to be medically cleared for respirator use (PAPR)
• Ability to operate different types of production equipment.
• Ability to gown correctly for clean room manufacturing operations.
• Ability to stand or sit for extended periods (up to 4 hours at a time).
• Must be able to work in an office and a manufacturing environment.

Essential Functions:

The essential functions of this position include:

• Production, bulk packaging, and inspection of pharmaceutical drug formulations
• Assisting with facility cleaning and operational maintenance
• Cleaning all manufacturing equipment and areas
• Assisting with facility and process validations as required
• Assisting with environmental and water system monitoring as required
• Assisting with RCRA and safety inspections as required
• Documenting all work as required by cGMPs and GDPs on a timely basis
• Reading and following all Company SOPs and guidelines
• Abiding by all safety requirements as defined by the company
• Completing other tasks as assigned by supervision