BS degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline with a minimum of 14 years of relevant experience in biopharmaceutical process development, manufacturing, validation, or commercialization; Master's degree in a relevant discipline with a minimum of 10 years of experience: PhD with a minimum of 7 years of experience. The role will partner with Drug Substance, Drug Product, Analytical Sciences, Quality, Regulatory Affairs, Manufacturing Operations, and external CMOs or CDMOs to ensure that process knowledge, validation strategy, control strategy, and filing content are scientifically sound, consistent, and inspection ready.