Sr Manufacturing Associate I-Bulk Days
2 days ago
POSITION SUMMARY
High-level position for persons to manufacture commercial scale batches.
MAJOR RESPONSIBILITIES
- Lead other operators and small groups as directed by the Supervisor.
- Production, filling, and inspection of pharmaceutical formulations.
- Assist with facility cleaning and operational maintenance.
- Assist with facility and process validations as required.
- Perform aseptic production operations and validations.
- Assist with environment and water system monitoring as required.
- Assist with clean room sanitization as required.
- Assist with RCRA and safety inspections as required.
- Document all work as required by CGMPs on a timely basis.
- Read and follow all company SOPs and guidelines.
- Abide by all safety requirements as defined by the company.
- Train newly qualifying personnel.
- Provide coaching and feedback for currently qualified personnel.
- Other tasks as assigned by the Supervisor.
COMPETENCIES
- General knowledge of the Scientific Method.
- General math skills, including simple algebra.
- Through knowledge of and adherence to Current Good Manufacturing Practices.
- General knowledge of chemistry and biology.
- General knowledge of steam/dry heat sterilization theories.
- 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.
- General knowledge of and ability to participate in customer, internal and FDA audits.
- Excellent documentation skills.
- Ability to act in a leadership role as production situations demand.
- Ability to mentor newly hired and progressively qualifying personnel.
- Detail oriented.
- Willing to learn new tasks and skills.
- Works well in a team environment.
- Respond quickly to assignments.
- Readily adapts to changing job duties.
- Manages time well; ability to multi-task.
- Positive attitude.
- Effective written and verbal communication skills.
- Effective trainer (coach).
- Displays understanding of and promotes company and customer objectives.
Physical Requirements:
- Occasional periods of repetitive motion.
- Ability to gown in an aseptic manner for clean room operations.
- 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.
EDUCATION AND EXPERIENCE
Basic Qualifications:
- High school diploma or equivalent.
- 4-5 years of experience in a pharmaceutical operation.
Preferred Qualifications:
- Associate degree or higher in science/technical discipline
- 4-5 years of experience in a sterile pharmaceutical operation.
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.
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