The MCS Manufacturing Associate will be a key player in the dynamic production environment, supporting development, clinical, and launch activities. Working under general supervision, this role will involve hands-on operations in a GMP-regulated environment, including equipment setup, cleaning, sanitization, and basic troubleshooting. This position requires strict adherence to SOPs and safety protocols.

Key Responsibilities:

• Set up, clean, and sanitize manufacturing equipment.
• Prepare buffers and media following manufacturing procedures (MPs) and SOPs.
• Monitor critical processes and perform basic troubleshooting when necessary.
• Perform in-process sampling and operate analytical equipment.
• Maintain a clean, organized, and compliant workspace.
• Work in a cleanroom environment, wearing steel-toe shoes, full gowning, hairnet, and gloves.
• Draft and revise SOPs and MPs, as needed.
• Assist with reviewing documentation such as equipment logs and batch records.
• Participate in and initiate quality reports.
• Identify, recommend, and implement improvements to daily processes.
• Regularly lift up to 35 lbs, push/pull up to 50 lbs, and perform physically demanding tasks like bending, climbing, and standing for extended periods.

Top Skills Needed:

• Strong ability to work effectively in teams.
• Ethical approach with a solid work ethic.
• Problem-solving skills and initiative in daily tasks.

Requirements

Required Qualifications:

• Bachelor’s degree, or
• Associate degree with 4 years of relevant experience, or
• High school diploma/GED with 6 years of relevant experience.

Physical Requirements:

• Ability to lift, push, pull, and move objects up to 50 lbs.
• Perform physical activities such as bending, reaching, climbing, kneeling, squatting, and walking upstairs.
• Standing on portable stairs or ladders up to 6 feet off the ground.

Work Schedule:
Flexibility is required to work various shifts, including day, swing, graveyard, weekends, and holidays. Shifts may vary between 5x8, 4x10, or 3-4x12 hour schedules based on production demands.