Manufacturing Support Biopharma

Job Description

Job Description

Manufacturing Support Associate (Biopharmaceutical Manufacturing)

Position Summary
The Manufacturing Support Associate provides operational and technical support to biopharmaceutical manufacturing operations to ensure the safe, efficient, and compliant production of biologics, vaccines, cell and gene therapies, or other pharmaceutical products. This role supports GMP manufacturing by coordinating materials, documentation, equipment readiness, and production activities while ensuring compliance with regulatory requirements and quality standards.

Key Responsibilities

• Support daily manufacturing operations for upstream, downstream, formulation, filling, or packaging processes.
• Prepare manufacturing suites by staging materials, equipment, and documentation prior to production.
• Review and execute batch records, SOPs, and work instructions in accordance with current Good Manufacturing Practices (cGMP).
• Monitor manufacturing processes and document production data accurately and in real time.
• Assist with equipment setup, operation, cleaning, sanitization, and preventive maintenance activities.
• Coordinate material movement, inventory management, and production scheduling with warehouse and planning teams.
• Support deviation investigations, CAPAs (Corrective and Preventive Actions), and change control activities.
• Perform line clearances and ensure manufacturing areas meet cleanliness and environmental requirements.
• Collaborate with Quality Assurance, Quality Control, Validation, Engineering, and Supply Chain to resolve production issues.
• Participate in technology transfers, process improvements, and continuous improvement initiatives using Lean Manufacturing or Six Sigma principles.
• Maintain compliance with FDA, EMA, ICH, and company quality standards.
• Assist with process documentation, training records, and manufacturing metrics.

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, Biomedical Engineering, Microbiology, Chemistry, or a related scientific discipline.
• 0–3 years of experience in biopharmaceutical, pharmaceutical, biotechnology, or regulated manufacturing environments.
• Understanding of cGMP regulations and pharmaceutical manufacturing principles.
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office (Excel, Word, Outlook).

Preferred Qualifications

• Experience working in GMP manufacturing, CDMO, or pharmaceutical production.
• Familiarity with batch record documentation and electronic quality management systems.
• Knowledge of upstream cell culture, downstream purification, aseptic processing, or fill-finish operations.
• Experience with ERP or MES systems (SAP, Syncade, DeltaV, PAS-X, or similar).
• Understanding of deviation investigations, CAPA, and change control processes.
• Lean Manufacturing or Six Sigma experience is a plus.

Key Skills

• GMP Documentation
• Manufacturing Operations
• Process Support
• Batch Record Review
• Equipment Preparation
• Material Coordination
• Root Cause Analysis
• Cross-Functional Collaboration
• Problem Solving
• Technical Documentation
• Continuous Improvement
• Regulatory Compliance

Physical Requirements

• Ability to stand for extended periods.
• Ability to lift up to 35 pounds.
• Ability to wear required personal protective equipment (PPE), including gowning for cleanroom