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Manufacturing Scientist (USP)

Pharma Universe
Piscataway, NJ Full Time
POSTED ON 4/10/2025
AVAILABLE BEFORE 10/6/2025
Upstream Manufacturing Scientist - Biologics

The Upstream Manufacturing Scientists will lead mammalian cell culture and bioreactor operations up to 2000l for cGMP commercial operations. You'll be at the forefront of recombinant biologics protein production in a cGMP environment,

Responsibilities:

  • Optimize bioreactor performance and scale-up procedures to meet production goals and maintain product quality
  • Develop and refine operating equipment specifications and implement improvements to upstream manufacturing techniques.
  • Work collaboratively with a team of manufacturing associates and engineers to execute upstream batches efficiently
  • Establish and refine operating equipment specifications to enhance manufacturing techniques
  • Interpret and communicate instructions in various formats (written, verbal, diagrammatic) to ensure clarity and compliance
  • Follow GMP guidelines and lead efforts to maintain environmental health and safety policies in the manufacturing area
  • Review executed manufacturing and packaging batch records along with supporting documents for accuracy and compliance
  • Coordinate investigations and corrective actions for any issues identified during the batch execution process
  • Perform additional functions as required to support team objectives and compliance with all company policies and standards


Experience/Qualifications:

  • Bachelor's or Master's degree in chemical, biological, or biochemical sciences with a minimum of 3 years of relevant experience in the biopharmaceutical sector
  • Proficiency in independently planning, executing, analyzing, and documenting all phases of process development
  • Strong foundational knowledge and expertise necessary to manage engineering and clinical batches
  • Previous experience in GMP and aseptic manufacturing settings
  • Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds

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