职位描述
Responsibilities (including but not limited to)
•Provide technical leadership, management, oversight and strategic guidance for early and late stage programs including process development, scale up, tech transfer, scale-down model, process characterization, process validation and BLA-enabling activities.
•Author and review CMC sessions for regulatory submissions
•Oversee and define project scope and ensure successful delivery regarding technical quality, timeline and budget
•Work with cross-functional teams and support senior leadership in defining and executing against short-term and long-term strategic goals
•Establish and maintain an understanding of current trends and emerging cell culture process technologies
•Apply innovative thinking and technical knowledge to design experiment and analyze data.
•Ensure well-organized, clear and complete records of all activities across areas of responsibility
•Manage and mentor junior staff in the cell culture process development group
任职条件
Qualifications
•Requires a PhD with 6-10 years of cell culture process development leadership experience in biotech industry
•Significant experience in the areas of cell culture process development, scale up of bioreactors and GMP manufacturing, process characterization, tech transfer, process validation and BLA-enabling activities
•Experience in preparing and defending regulatory documents (BLAs/INDS)
•Knowledge of cGMP regulations
•Strong experience and knowledge in process validation highly desired
•Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
•Excellent team building, leadership and management skills
•Strong technical/analytical skills to identify and solve problems
•Proven ability to work with a high level of integrity, accuracy, and attention to detail
•Strong organizational skills for high productivity, innovation and priority-setting to complete assignments on time and on budget
•Excellent oral and written communication skills
•Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
•Resourceful, creative, enthusiastic, and results-oriented