Overview
We are seeking a motivated Manufacturing Associate I to support biopharmaceutical production operations in a GMP-regulated environment. This role is ideal for recent graduates with a Bachelor's degree in Biology, Microbiology, Biotechnology, Biochemistry, or a related life sciences field, as well as candidates with early industry experience. The Manufacturing Associate will be responsible for executing production activities, maintaining accurate documentation, and supporting the manufacture of biological products while adhering to quality and regulatory standards.
Key Responsibilities
- Execute upstream and downstream manufacturing activities according to approved procedures and batch records.
- Perform media preparation, buffer preparation, aseptic processing, and equipment setup/cleaning.
- Support bacterial and viral production processes.
- Complete and review batch production records for accuracy and compliance.
- Conduct filling, packaging, labeling, and inspection activities.
- Monitor manufacturing processes and document results in accordance with GMP requirements.
- Identify and upscale deviations, quality events, and process issues.
- Maintain cleanroom standards and follow aseptic techniques.
- Assist with inventory management, material handling, and equipment preparation.
- Participate in training, continuous improvement initiatives, and safety programs.
Required Qualifications
- Bachelor's degree in Biology, Biotechnology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline.
- Strong attention to detail and documentation skills.
- Ability to follow standard operating procedures (SOPs) and work instructions.
- Basic understanding of laboratory practices and scientific principles.
- Strong communication and teamwork skills.
- Ability to work in a regulated manufacturing environment.
Preferred Qualifications
- Internship, co-op, research, or industry experience in pharmaceutical, biotechnology, biologics, or life sciences manufacturing.
- Exposure to GMP documentation and batch records.
- Experience with media preparation, aseptic techniques, or cell culture operations.
- Knowledge of filling, packaging, visual inspection, or production support activities.
- Familiarity with cleanroom operations.
Key Skills
- GMP Documentation
- Batch Record Review
- Media Preparation
- Aseptic Processing
- Cleanroom Operations
- Filling & Packaging
- Visual Inspection
- Process Compliance
- Problem Solving
- Team Collaboration