MCS Manufacturing Associate

The BioPharma Consulting JAD Group is currently seeking a highly motivated MCS Manufacturing Associate to join our team. This role offers the opportunity to support development, clinical, and launch activities in a dynamic production environment.

Key Responsibilities:

• Hands-On Operations:
• Set-up, clean, and sanitize various manufacturing equipment.
• Prepare buffers/media following Manufacturing Procedures (MPs) and SOPs.
• Perform and monitor critical processes, with the ability to execute basic troubleshooting.
• Perform in-process sampling and operate analytical equipment.
• Execute washroom activities, including cleaning small and large-scale equipment used in production.
• Compliance and Documentation:
• Adhere strictly to GMP documents (SOPs, MPs) with a focus on safety and compliance.
• Draft and revise routine documents, including SOPs, MPs, and technical reports.
• Initiate and manage quality incidents, including drafting quality reports.
• Process Improvement:
• Identify, recommend, and implement improvements related to routine functions.
• Assist in reviewing documentation for assigned functions, such as equipment logs and batch records.
• Clean Room Environment:
• Work in a clean room environment, following all gowning and safety protocols, including wearing steel toe shoes, full clean room gowning, hairnet, and gloves.
• Physical Requirements:
• Regularly lift up to 35 lbs., and push/pull objects requiring up to 50 lbs. of force.
• Perform physically demanding tasks, including bending, reaching, climbing, kneeling, squatting, and standing on ladders up to 6 feet off the ground.
• Work on your feet for extended periods.
• Teamwork and Initiative:
• Collaborate with team members to complete operational tasks.
• Follow directions, documents, and policies consistently, and take initiative when necessary.
• Create a positive work environment through effective interactions with team members.

Preferred Qualifications:

• Technical Writing:
• Demonstrated capability in drafting and revising technical documents.
• Project Management:
• Skills in project management and the ability to present technical information clearly.
• Scientific Understanding:
• Ability to apply basic chemistry, biology, and physical principles in a manufacturing setting.
• Safety and Training:
• May train staff on hands-on tasks and act as a safety representative.

Requirements

Basic Qualifications:

• Education:
• Bachelor’s degree OR Associate’s degree with 4 years of experience OR High school diploma/GED with 6 years of experience.
• Shift Flexibility:
• Available to work various shifts (day, swing, graveyard), including weekends and holidays, as required by production schedules.
• Perform activities involving periods of rigorous, repetitive work and work around high-pressure systems and heavy equipment.