We are seeking Downstream Manufacturing Scientists to join a growing biopharma organization with a global footprint in both R&D and manufacturing. This is a career-defining opportunity for candidates passionate about driving innovation in upstream operations within a GMP-compliant manufacturing environment.

Type: Contract-to-Hire
Location: Middlesex County, NJ
Rate: $80K-$100K
Shift: Day & Night Shift Available

Summary:

• The Upstream Manufacturing Scientist executes purification of mammalian cell culture products for biosimilar programs, supporting engineering, commercial, and clinical batches from 50 L to 1000 L in a cGMP environment. 

Responsibilities:

• Conduct downstream purification of mammalian cell culture products at multiple scales in a cGMP setting, including column preparation, process troubleshooting, and data evaluation

• Provide technical oversight and support for purification process execution and development

• Track and interpret process data to make adjustments to operations or equipment in real time

• Manage engineering and clinical batch schedules to ensure timely completion

• Establish and maintain equipment operating parameters while identifying opportunities to improve purification techniques

• Collaborate with internal teams and external vendors to address technical challenges and support maintenance of production systems

• Follow GMP, safety, and environmental health standards in all manufacturing activities

• Lead or assist in investigations and corrective actions related to deviations or process issues

• Perform additional responsibilities as assigned while complying with all company policies

Qualifications:

• Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences with 4 - 5 years of experience in biopharmaceutical manufacturing

• Hands-on experience in GMP and aseptic production environments

• Proficiency with AKTA purification systems (or equivalent) and single-use components such as bags, tubing sets, columns, and manifolds

• Competence in executing engineering and clinical batches with knowledge of GMP documentation requirements

• Strong interpersonal, verbal, and written communication skills; well-organized and detail-oriented

• Familiarity with GMP batch manufacturing and packaging documentation, including audits and record review

• Experience with cleaning verification and validation procedures

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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