Upstream Manufacturing Associate

Pharma Universe; Piscataway Township (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking an Upstream Manufacturing Scientist to enhance their mammalian cell culture operations for biosimilar development. This exciting role involves executing engineering and clinical batches in a cGMP environment, operating bioreactors, and ensuring compliance with regulatory standards. The ideal candidate will have a strong technical background in upstream processing, excellent documentation skills, and the ability to work independently or collaboratively. Join a dynamic team committed to innovation and quality in biopharmaceutical manufacturing, where your contributions will directly impact the development of life-saving therapies.

Qualifications

• 3+ years of experience in biopharmaceutical manufacturing focused on upstream processing.
• Hands-on experience with bioreactor operations in a GMP environment.

Responsibilities

• Execute mammalian cell culture batches at varying scales in compliance with GMP.
• Collaborate with teams and ensure accurate batch execution aligned with schedules.

Skills

Interpersonal Skills

Communication Skills

Documentation Practices

Detail-oriented

Organizational Skills

Education

Bachelor's degree in chemical, biological, or biochemical sciences

Master's degree in chemical, biological, or biochemical sciences

Tools

Microsoft Word

Microsoft Excel

Single-use systems

Job description

An Upstream Manufacturing Scientist will support mammalian cell culture operations involved in the production of recombinant proteins for biosimilar development. This includes the execution of engineering and clinical batches ranging from 50 L to 1000 L in a cGMP environment.

The role requires hands-on experience with bioreactor operations, strong technical understanding of upstream processing, and the ability to manage documentation such as batch records, protocols, and investigations in compliance with regulatory standards.

Key Responsibilities

• Support upstream processing activities by executing mammalian cell culture batches at varying scales
• Operate bioreactors and associated systems for both engineering and clinical production runs
• Collaborate with cross-functional teams, while also working independently with minimal supervision
• Ensure timely and accurate batch execution aligned with production schedules
• Develop and refine operating specifications and contribute to process improvements
• Use data collection systems to monitor and adjust process parameters in real-time
• Interpret and act on instructions provided in various formats, including written, oral, and diagram-based
• Adhere strictly to GMP standards and environmental health and safety policies
• Review completed batch records and associated documents for accuracy and compliance
• Support investigation efforts related to deviations or issues during batch execution
• Perform additional manufacturing-related duties as assigned
• Maintain compliance with internal policies and quality standards

Requirements

Education & Experience

• Bachelor's or Master's degree in chemical, biological, or biochemical sciences
• Minimum 3 years' experience in biopharmaceutical manufacturing, with a focus on upstream processing
• Proficient in executing and analyzing engineering and clinical-scale batches
• Experience working in GMP-compliant and aseptic environments
• Familiarity with single-use systems (bags, tubing, columns, process manifolds)

Skills & Knowledge

• Strong interpersonal and communication skills
• Proficient in documentation practices and batch record review
• Basic computer skills, including Microsoft Word and Excel
• Knowledge of cleaning validation and verification processes
• Detail-oriented, organized, and capable of working across multiple projects