Position Summary:
- Entry-level role working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches.
Responsibilities (Essential Functions):
- Produce, bulk package, and inspect pharmaceutical drug formulations
- Assist with facility cleaning and operational maintenance
- Clean manufacturing equipment and areas
- Assist with facility and process validations as required
- Assist with environmental and water system monitoring as required
- Assist with RCRA and safety inspections as required
- Document work per cGMPs and GDPs in a timely manner
- Read and follow all company SOPs and guidelines
- Abide by all company safety requirements
- Complete other tasks as assigned by supervision
Qualifications:
- Preferred: Basic knowledge of the Scientific Method; basic math skills (including percentages); adherence to current GMPs and GDPs
- Preferred: Basic knowledge of chemistry and biology; HAZCOM, RCRA, and other safety requirements; mechanical aptitude
- Preferred: Good documentation skills; ability to learn operation of production equipment (e.g., blenders, HMIs, tablet presses, coaters, wash-off lines, comils)
- Preferred: Ability to read/follow SOPs; basic computer skills (Microsoft Suite, SAP, Veeva Vault, LMS)
- Preferred: Understanding of Master Batch Records; detail-oriented; willingness to learn/adapt; team-oriented; positive attitude; ability to follow procedures for high-quality product
Education & Experience (varies by level):
- Associate I: High school diploma or equivalent; 0β1 years pharmaceutical manufacturing (preferably OSD)
- Associate II: High school diploma or equivalent; 1β3 years pharmaceutical manufacturing; 1+ year OSD; associate degree or higher in science/technical discipline preferred
- Associate III: High school diploma or equivalent; 4β5 years pharmaceutical manufacturing; 2β3 year OSD; associate degree or higher in science/technical discipline preferred
Working/Physical Requirements:
- Available for any shift with possible overtime
- Lift/move 40 lbs overhead; push/pull equipment or product using a pallet jack
- Gown/don PAPR for potent controlled substances; medically cleared for respirator use
- Operate production equipment; gown for clean room operations; stand/sit up to 4 hours; work in office and manufacturing environments