Manager, Manufacturing (Upstream)

The Upstream Manufacturing Manager will oversee mammalian cell culture processes involved in producing recombinant proteins for a diverse portfolio of mammalian-based Biologics. This role involves the execution of upstream operations for engineering and clinical batches ranging from 50 L to 2000 L in a cGMP-regulated environment. The ideal candidate will possess strong technical knowledge of bioreactor operations, cell biology, and the documentation practices required for compliant manufacturing.

Key Responsibilities:

• Collaborate with a cross-functional team of engineers and manufacturing staff to carry out upstream production activities.
• Operate bioreactors and perform cell culture processes across multiple scales, including harvest procedures.
• Ensure timely execution of both engineering and clinical manufacturing batches.
• Develop equipment specifications and continuously improve upstream manufacturing methods.
• Utilize process data collection tools to analyze trends and make real-time adjustments as needed.
• Apply advanced upstream knowledge to identify and resolve technical issues.
• Comprehend and implement instructions presented in various formats—written, oral, diagrammatic, or scheduled.
• Adhere to and lead compliance with GMP and environmental health and safety regulations in the production space.
• Review completed manufacturing and packaging batch records, along with related documentation.
• Support investigations and implement corrective actions for deviations encountered during batch execution.
• Perform additional tasks as directed.
• Uphold all company policies and quality standards.

Qualifications & Experience:

• Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences, with a minimum of 10 years of experience in the biopharmaceutical sector.
• Deep expertise in upstream processing, including cell expansion and harvest workflows.
• Demonstrated ability to lead the execution of engineering and clinical manufacturing batches.
• Hands-on experience in GMP-compliant and aseptic production environments.
• Familiarity with both stainless steel and single-use bioreactor systems is essential.
• Strong communication skills, both written and verbal; detail-oriented with sound organizational and computer literacy.
• Proficient with standard software tools such as Word and Excel.
• Solid understanding of GMP documentation practices, including batch records and audit readiness.
• Experience with cleaning validation and verification procedures.