Key Responsibilities:

Design, develop, and optimize biotechnology processes for the production of biopharmaceutical products, including cell culture, purification, and analytical methods.
Collaborate with cross-functional teams to identify process improvement opportunities and develop innovative solutions to enhance product quality and yield.
Utilize statistical analysis and design of experiments (DOE) to optimize process parameters and troubleshoot process issues.
Develop and implement process control strategies to ensure consistent and reproducible product quality.
Conduct process scale-up studies to support technology transfer to manufacturing sites.
Author and review technical documents, including process development reports, protocols, and batch records.
Stay current with industry trends and advancements in biotechnology process development, and apply this knowledge to improve processes and procedures.
Train and mentor junior team members on process development techniques and best practices.

Qualifications:

Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
Minimum of 3 years of experience in process development within the biotechnology or pharmaceutical industry.
Strong knowledge of biotechnology processes, including cell culture, purification, and analytical methods.
Experience with statistical analysis and design of experiments (DOE) for process optimization.
Familiarity with process scale-up and technology transfer to manufacturing.
Excellent problem-solving skills and ability to troubleshoot process issues.
Strong communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.
Knowledge of cGMP regulations and FDA guidelines for biopharmaceutical production.
Experience with process validation and authoring technical documents is preferred.

Join our team and be a part of shaping the future of biopharmaceutical production.

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