Downstream Bioprocess Development Manager (3147)

About the Role:

We are seeking an experienced and highly motivated Downstream Bioprocess Development Manager. In this role, you will be responsible for developing protein purification processes, including Chromatography, UF/DF, filtration, and precipitation, ensuring the highest quality proteins are produced efficiently and in a manufacturing-friendly manner.

You will lead a dynamic team of scientists and technicians and collaborate with other teams in protein production and analytics to drive innovation and success.

Key Responsibilities:

• Lead the development and optimization of protein purification processes (Chromatography, UF/DF, filtration, precipitation) across various systems.
• Manage and mentor a team of scientists and technicians to ensure successful project execution.
• Oversee process validation, process upscaling, and technology transfer to support clinical batch manufacturing.
• Develop DSP processes in line with regulatory requirements, including continuous process development and PAT integration.
• Write development reports, and contribute to CTD chapters for regulatory submissions.
• Manage project timelines, resources, and budgets to achieve business goals.

Qualifications:

• PhD in Biotechnology Engineering, Biochemistry, or Life Sciences.
• Minimum of 5 years of experience in the pharmaceutical industry, with at least 3 years in a team leadership role.
• Strong experience in GMP manufacturing and process validation.
• Proven expertise in DSP Development, technological transfer, and regulatory submissions.
• Experience in CMC development, process validation, and support for clinical batch manufacturing.
• Excellent communication and leadership skills with a strong ability to collaborate across teams.