MCS Manufacturing Associate-Purification

BioPharma Consulting JAD Group is seeking a dedicated MCS Manufacturing Associate for a dynamic role in Thousand Oaks, CA. This position supports critical development, clinical, and launch activities within a state-of-the-art manufacturing environment. Under general supervision, the associate will execute various manufacturing operations aligned with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).

Key Responsibilities

• Perform setup, cleaning, and sanitization of various manufacturing equipment.
• Prepare buffers and media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs).
• Follow GMP documents (SOPs, MPs) with strict adherence to safety and compliance guidelines.
• Monitor critical processes and perform basic troubleshooting.
• Collect in-process samples and operate analytical equipment.
• Clean small and large-scale equipment used in production activities.
• Maintain an organized and clean workspace.
• Work in a cleanroom environment, following full gowning procedures and using safety equipment.
• Initiate quality reports and draft/revise SOPs, MPs, and technical documents.
• Recommend and implement improvements for routine processes.
• Review documentation, including equipment logs and batch records.
• Perform physical tasks such as lifting, bending, climbing, and working with heavy equipment.
• Work in shifts, including weekends, holidays, and extended hours as required.
• Train other team members and ensure compliance with safety standards.

Top Skills Required

• Strong mechanical ability and technical troubleshooting skills.
• Basic statistical and mathematical skills.
• Knowledge of GMP regulations and experience applying them in manufacturing.
• Familiarity with analytical methods used in manufacturing.
• Experience with Delta V and lab equipment/testing.
• Excellent technical writing and documentation skills.
• Ability to manage projects and present findings.
• Understanding of basic chemistry, biology, and physical principles.
• Ability to lift up to 35lbs and push/pull up to 50lbs of force.

Day-to-Day Responsibilities

• Perform critical process operations and execute routine validation protocols.
• Draft and revise routine documents (e.g., MPs, SOPs, technical reports).
• Initiate quality incidents and troubleshoot equipment issues.
• Assist in reviewing documentation and ensuring compliance with GMP standards.
• Direct operators on critical processes and train team members as needed.
• Work with high-pressure systems and heavy equipment as necessary.

Requirements

Basic Qualifications

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

Preferred Qualifications:

• A degree in Biology or Life Sciences.
• Experience in a regulated manufacturing environment (GMP).
• Mechanically inclined or engineering background.

Shift Flexibility
Candidates must be available to work various shifts (day, swing, graveyard, weekends, holidays) as required by the production schedule.