This position reports to a Supervisor, Manufacturing.
Position Summary:
This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches.
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
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.
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.
