Job Description
Upstream Manufacturing Associate Night Shift (3rd Shift: 10:00 PM 6:00 AM)
Full-Time | Onsite New Jersey, USA
Relocation support offered
Seeking an experienced Upstream Manufacturing Associate to support night shift operations in a cGMP-regulated biopharmaceutical facility. This role is critical in executing mammalian cell culture processes for biosimilar production during the 3rd shift (10:00 PM 6:00 AM), ensuring 24/7 continuity of manufacturing activities.
Key Responsibilities:
- Perform upstream processing activities including cell culture and bioreactor operations (50 L to 1000 L scale) during overnight hours
- Prepare and operate single-use bioreactors and associated equipment in compliance with batch protocols and cGMP standards
- Monitor critical process parameters and maintain detailed, accurate documentation of batch execution and deviations
- Collaborate with cross-functional teams to ensure readiness and smooth handoffs between shifts
- Support investigations, corrections, and continuous improvements related to batch execution
- Maintain a safe and clean manufacturing environment, adhering to all environmental health and safety procedures
- Assist in reviewing executed batch records and support documentation related to upstream operations
Requirements:
- Bachelor's or Master's degree in Biochemistry, Biology, Chemical Engineering, or a related field
- Minimum 3 years of hands-on upstream manufacturing experience in a GMP biologics setting
- Strong experience with aseptic techniques and single-use systems (bags, tubing, manifolds, etc.)
- Proficient in bioreactor operations, with a solid understanding of mammalian cell culture
- Willingness and ability to work overnight (3rd shift) on a consistent schedule
- Detail-oriented with strong documentation and communication skills
- Comfortable working both independently and as part of a team
This position offers a great opportunity for those looking to advance in a dynamic biologics manufacturing environment while working a stable night shift schedule.
Key skill Required
- Manufacturing
- Batch Records
- Biochemistry
- Biology
- Cell Culture
- Chemical Engineering
- Communication
- Compliance
- Consistent
- Documentation
- Environmental
- Environmental Health
- Environmental Health And Safety
- Mammalian Cell Culture
- Upstream
- Upstream Processing