Upstream Manufacturing Associate

Description

Upstream Manufacturing Scientist – Biologics

Type: Full-time

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.