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.
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.