Responsibilities:

• Collaborate with a team of manufacturing associates and engineers to execute upstream batches.
• Perform cell culture and bioreactor operations (single-use fed-batch bioreactors) at various scales.
• Conduct harvest clarification processes using centrifuges and depth filters at multiple scales.
• Ensure timely execution of engineering and clinical batches.
• Develop operating equipment specifications and improve manufacturing techniques.
• Utilize programs to collect and analyze operating data for real-time adjustments to products, instruments, or equipment.
• Interpret and follow instructions provided in written, oral, diagram, or schedule form.
• Adhere to GMP standards in the manufacturing area and lead compliance with environmental health and safety policies.
• Review executed manufacturing and packaging batch records, along with associated supporting documents.
• Coordinate investigations and implement corrections for issues identified during batch execution.

Qualifications:

• BS or MS in chemical, biological, or biochemical sciences
• 3+ years of related experience in the biopharmaceutical industry.
• Experience working in GMP and aseptic manufacturing environments.
• In-depth knowledge of GMP batch manufacturing and packaging documentation, including audit and review processes.
• Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.