Upstream Manufacturing Associate I

Planet Pharma; Pennington (NJ); On-site; USD 28,000 - 39,000; Full time

Job summary

Planet Pharma is seeking an Upstream Manufacturing Associate I in the United States (New Jersey, Pennington) to execute day-to-day upstream manufacturing in a cGMP cleanroom. You will assist media/buffer prep, seed train expansion, bioreactor support, and harvest work, ensuring compliance with GMP.

The role requires basic cell culture understanding, strict documentation, and adherence to aseptic techniques.

Qualifications

• Understanding of biological manufacturing and cell culture workflows.
• Ability to follow detailed procedures and batch records precisely.
• Strong documentation practices and attention to detail are essential.
• Effective communication and teamwork are required in a cGMP setting.
• Knowledge of cGMP requirements is preferred but not mandatory.

Responsibilities

• Prepare media and buffers per procedures and batch records.
• Support vial thaw, shake flask culture, seed train expansion, and bioreactor activities.
• Assist fed-batch and perfusion bioreactor operations.
• Perform harvest and filtration activities.
• Carry out equipment setup, cleaning, sanitization and routine maintenance.
• Perform aseptic manufacturing in cleanroom environments and follow gowning rules.
• Document batch records, logbooks, and GMP documentation accurately.
• Follow SOPs and report deviations or issues.
• Support audits and inspection readiness activities.
• Participate in training and process improvement projects.

Skills

Biotech knowledge

Cell culture processes

Documentation accuracy

Communication & teamwork

cGMP familiarity

Education

Bachelor's degree in biotechnology / life sciences

High School Diploma with 4+ years biopharma exp.

Job description

Pay range: 20-28/hr

*depending on experience

Position Overview

The Upstream Manufacturing Associate I is responsible for executing day-to-day upstream manufacturing operations in a cGMP cleanroom environment. This position supports cell culture manufacturing activities including media and buffer preparation, seed train expansion, bioreactor operations, harvest processing, equipment cleaning, and aseptic processing while ensuring compliance with GMP requirements.

Key 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

• Perform manufacturing activities within classified cleanroom environments.
• Adhere to aseptic techniques and contamination control procedures.
• Follow gowning and cleanroom behavior requirements.

Documentation & Compliance

• Complete batch records, logbooks, and associated 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.

Continuous Improvement

• Participate in training programs and qualification activities.
• Support process improvement initiatives and operational excellence projects.

Qualifications

Education & Experience

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

Required Skills

• Basic understanding of biological manufacturing and cell culture processes.
• Ability to follow detailed instructions and procedures.
• Strong attention to detail and documentation practices.
• Effective communication and teamwork skills.
• Knowledge of cGMP requirements is preferred.

Preferred Skills

• Experience with:
  • Cell culture operations
  • Shake flask cultivation
  • Bioreactor systems
  • Buffer and media preparation
  • Single-use technologies
  • Aseptic processing

Physical Requirements

• Ability to stand for extended periods.
• Ability to bend, reach, and lift up to 50 pounds.
• Ability to work in cleanroom environments while wearing required PPE.