Upstream Manufacturing Associate I - 2nd Shift (Biotech)

System One; Pennington (NJ); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Job summary

System One is seeking a Manufacturing Associate I, Upstream Processing (2nd Shift) in Pennington, NJ. You will execute day-to-day upstream manufacturing operations in a CGMP cleanroom, handling media and buffer preparation, seed train expansion, bioreactor support, harvest processing, and aseptic processing to ensure GMP compliance.

The role requires basic biology manufacturing knowledge, strong attention to detail, good documentation, teamwork, and the ability to stand for long periods, lift up

Qualifications

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related field with 0–2 years of relevant experience.
• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.

Responsibilities

• Upstream Manufacturing Operations.
• Prepare media and buffers according to approved procedures and batch records.
• Perform vial thaw, shake flask culture, seed train expansion, and bioreactor support activities.
• Support fed-batch and perfusion bioreactor operations.
• Execute harvest and filtration activities.
• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.
• Aseptic processing in classified cleanroom environments.
• Adhere to aseptic techniques and contamination control procedures.
• Follow gowning and cleanroom behavior requirements.
• Complete batch records, logbooks, and GMP documentation accurately and contemporaneously.
• Follow SOPs, batch records, and work instructions.
• Report deviations, equipment issues, and atypical events to supervision.
• Support internal audits and inspection readiness activities.
• Participate in training programs and qualification activities.
• Support process improvement initiatives and operational excellence projects.

Skills

Biological manufacturing knowledge

Cell culture operations

Documentation practices

Teamwork and communication

cGMP awareness

Physical stamina and PPE handling

Education

Bachelor's degree in Biotechnology or Life Sciences

High School Diploma with 4+ years biopharmaceutical experience

Tools

Bioreactor systems

Shake flask cultivation

Single-use technologies

Buffer and media preparation

Job description

System One is seeking a Manufacturing Associate I, Upstream Processing (2nd Shift) in Pennington, NJ. You will execute day-to-day upstream manufacturing operations in a CGMP cleanroom, handling media and buffer preparation, seed train expansion, bioreactor support, harvest processing, and aseptic processing to ensure GMP compliance.

The role requires basic biology manufacturing knowledge, strong attention to detail, good documentation, teamwork, and the ability to stand for long periods, lift up