There are multiple openings for this position.

Position Summary

The Upstream Manufacturing Scientist conducts mammalian cell culture processes and produces recombinant proteins for mammalian-based biosimilars, handling cell culture batches from 50 L to 1000 L in a cGMP environment. This role requires expertise in bioreactor operations, cell biology, and proficiency in batch records, protocols, and technical documentation. The individual must work collaboratively in teams and independently with minimal supervision.

Key Responsibilities

• Collaborate with teams to execute upstream batches and operate bioreactors at various scales.
• Ensure timely completion of engineering and clinical batches.
• Develop equipment specifications and enhance manufacturing techniques.
• Monitor operating data and perform real-time adjustments.
• Interpret instructions in various formats and adhere to GMP and safety policies.
• Review manufacturing batch records and manage investigations as needed.
• Perform additional duties as assigned and comply with company policies.

Qualifications

• Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with 3+ years in biopharmaceuticals.
• Experience with bioreactors or fermenters.
• Strong expertise in process development, batch execution, and analysis.
• Experience in GMP and aseptic environments, including use of single-use manufacturing tools.
• Proficient communication, teamwork, computer, and organizational skills.
• Knowledge of GMP documentation, cleaning verification, and validation.