Summary:
Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR’s 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 individual Learning Management System.
Job Description:
- Read and follow detailed written SOP’s/MPR’s/Procedures.
- Document all work as required by cGMP’s on a timely basis.
- Execute tasks as directed with close attention to detail.
- Monitors process with close attention to detail.
- Follows Alkermes internal policies.
- Abide by all safety requirements as defined by the company.
- Perform Aseptic Gowning and maintaining gowning qualification. (this includes 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.
SKILLS/ABILITIES:
- General knowledge of aseptic fundamentals.
- General math skills, including using metric weight system.
- General Knowledge and Adherence to Current Good Manufacturing Practices.
- General Knowledge 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 skills.
- Excellent documentation skills.
PERSONAL ATTRIBUTES:
- Positive Attitude
- Integrity/Ethics
- Adaptability/Flexibility
- Dependability
- Detailed 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
Physical Requirements:
- 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 all be required.
- Ability to operate all types of production equipment (i.e., Rockwell HMI, Autoclaves, etc.)
- Ability to read, understand, and accurately follow company SOP’s and guidelines.
- Ability to lift/move up to 50 lbs. overhead. 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:
Basic Requirements:
- High School diploma or equivalent.
Preferred Requirements:
- 0-1 year of experience in a sterile pharmaceutical operation.
- Associates degree or higher in science/technical discipline.
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.