Overview:

Responsibilities:

• Develops platform processes and technologies.
• Designs experiments, analyzes data, and draws conclusions.
• Develops, optimizes, characterizes and troubleshoots cell culture processes to produce mAbs, gene therapy vectors, and other biologics.
• Designs, performs and analyzes small-scale cell culture experiments. Develops new cell culture growth and feed media formulations.
• Molecular and cellular biology techniques and processes.
• Keep accurate records in notebooks, organize and report results.
• Analyze data by statistical, Design of Experiment (DoE), and graphical procedures in order to provide accurate, concise and pertinent summaries and data reports.
• Collaborates with other groups within Process Development and the organization to meet organizational objectives.
• Transfers processes to the cGMP plant and supports cGMP manufacturing at up to 250L scale.
• Ensures that all work is properly documented and suitable for regulatory submission.
• Drafts technical reports to support technology transfer, regulatory and intellectual property submissions.
• Maintains substantial knowledge of state-of-the-art principles in cell culture technology.

Qualifications:

• Requires a PhD in a scientific discipline such as Bioengineering, Chemical engineering and Biochemistry
• Ability to adapt to a cGMP environment and maintain all work to cGMP standards.
• Excellent problem solving skills as well as time management and organizational skills.
• Strong oral and written communication skills
• Ability to multi-task with a strong attention to detail
• Ability to work flexible and at times, extended hours to meet business needs
• Adept in Microsoft Office products