Location:Chaska, MN, USAEmployment Type:Full TimeEmail Me This Job
This individual will lead the development of manufacturing processes for new products from benchtop scale to commercial scale using Quality by Design approach (ICH Q8). They will lead the manufacturing of development batches, facilitate projectcommunication and issue resolution with internal and external customers, and provide technical manufacturing process expertise as required. They will be accountable for delivery of key project financial deliverables. They will transfer benchtop scale manufacturing processes from customer site to Lifecore; scale up benchtop manufacturing processes to pilot scale and commercial scale; manufacture non-GMP and GMP development batches; evaluate and optimize manufacturing process design and performance using design of experiments (DOE) and statistical analysis; lead analysis of process improvements tocommercial product; create robust process development plans and reports. They will also proactively engage quality, manufacturing, and engineering as needed to support process development activities; present data and recommendations at internal and external project team meetings in a clear and logical manner and be able to support or defend recommendations; proactively assess future commercial scale manufacturing process while developing bench and pilot scale processes.
Requirements: BS/BA in chemistry, biochemistry, chemical engineering, or related science with 10+ years of appropriate industrial experience. Experience with processes or methods used in the pharmaceutical or biotechnology industry; experience leading multidisciplinary teams; FDA regulated industry experience. Experience with biopolymers and pre-clinical pharmaceutical process development preferred.