Manufacturing Associate-Filling 1st Shift
Alkermes
August 24, 2026
On-site
Cincinnati Metropolitan Area
Operations
Location: Wilmington, OH
Summary:
- Perform operational activities for filling microsphere/suspension/liquid products, including equipment cleaning/assembly/setup, equipment operation, and batch processing.
- Read and follow SOPs/MPRs with thorough cGMP documentation.
- Aseptically gown and maintain gowning qualification; perform area sanitizations as needed.
- Maintain training proficiency via the Learning Management System.
Responsibilities:
- Read and follow SOPs/MPRs/procedures.
- Document all work per cGMP on a timely basis.
- Execute tasks with close attention to detail; monitor the process.
- Follow internal policies and all safety requirements.
- Perform aseptic gowning (hood, coverall, boots, mask, goggles, gloves) and maintain qualification.
- Perform clean room sanitizations; equipment prep/assembly/setup.
- Operate filling equipment for microspheres/suspensions/liquids.
- Assist with development and validation activities as required.
- Other tasks as assigned; shift coverage/weekend work may be required.
Skills/Abilities:
- Aseptic fundamentals; math skills (metric system).
- Adherence to cGMP; knowledge of HAZCOM, RCRA, and safety requirements.
- Mechanical aptitude for minor non-routine adjustments and diagnosing equipment.
- Computer skills; excellent documentation.
Qualifications:
- Manufacturing Associate 1: HS diploma/equivalent; preferred: 0–1 year sterile pharma; associate+ in science/technical.
- Manufacturing Associate 2: HS diploma/equivalent; 1–3 years pharma manufacturing; preferred: 1+ year sterile; associate+ in science/technical.
- Manufacturing Associate 3: HS diploma/equivalent; 4–5 years pharma manufacturing; preferred: 2–3 years sterile; associate+ in science/technical.
Physical Requirements:
- Maintain aseptic gowning (annual requalification); lift/move up to 50 lbs overhead; team lift up to 100 lbs; stand 7+ hours in steel-toed shoes; walking/lifting/reaching/climbing/bending; operate production equipment.
Personal Attributes:
- Positive attitude, integrity/ethics, adaptability, dependability, detail-oriented, self-motivated, team-oriented, ownership/willingness to learn.
Summary:
- Perform operational activities for filling microsphere/suspension/liquid products, including equipment cleaning/assembly/setup, equipment operation, and batch processing.
- Read and follow SOPs/MPRs with thorough cGMP documentation.
- Aseptically gown and maintain gowning qualification; perform area sanitizations as needed.
- Maintain training proficiency via the Learning Management System.
Responsibilities:
- Read and follow SOPs/MPRs/procedures.
- Document all work per cGMP on a timely basis.
- Execute tasks with close attention to detail; monitor the process.
- Follow internal policies and all safety requirements.
- Perform aseptic gowning (hood, coverall, boots, mask, goggles, gloves) and maintain qualification.
- Perform clean room sanitizations; equipment prep/assembly/setup.
- Operate filling equipment for microspheres/suspensions/liquids.
- Assist with development and validation activities as required.
- Other tasks as assigned; shift coverage/weekend work may be required.
Skills/Abilities:
- Aseptic fundamentals; math skills (metric system).
- Adherence to cGMP; knowledge of HAZCOM, RCRA, and safety requirements.
- Mechanical aptitude for minor non-routine adjustments and diagnosing equipment.
- Computer skills; excellent documentation.
Qualifications:
- Manufacturing Associate 1: HS diploma/equivalent; preferred: 0–1 year sterile pharma; associate+ in science/technical.
- Manufacturing Associate 2: HS diploma/equivalent; 1–3 years pharma manufacturing; preferred: 1+ year sterile; associate+ in science/technical.
- Manufacturing Associate 3: HS diploma/equivalent; 4–5 years pharma manufacturing; preferred: 2–3 years sterile; associate+ in science/technical.
Physical Requirements:
- Maintain aseptic gowning (annual requalification); lift/move up to 50 lbs overhead; team lift up to 100 lbs; stand 7+ hours in steel-toed shoes; walking/lifting/reaching/climbing/bending; operate production equipment.
Personal Attributes:
- Positive attitude, integrity/ethics, adaptability, dependability, detail-oriented, self-motivated, team-oriented, ownership/willingness to learn.