Senior Director, Manufacturing-Madison, WI- 100% on-site
This is an exciting Executive leadership position responsible for overseeing strategic Manufacturing operations within a major US Biologics CDMO. You will be responsible for providing key leadership, direction, organization, management, monitoring, and cGMP compliance of the roles, activities, and proceedings of Manufacturing to ensure the successful, cost effective, timely, and safe processing of client projects. You will be charged with overseeing the following activities:
* Leading a 200+ person manufacturing organization comprised of upstream cell culture and downstream purification manufacturing operations teams including Manufacturing Directors, Managers and Supervisors.
* Develop the vision and direction of the Manufacturing operational strategy in conjunction with the Manufacturing vision set forth by the Head of Manufacturing.
* Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead tech transfers, process validation, process change control, deviation investigation and process characterization activities.
*Develops the manufacturing strategy and deploys initiatives to align with site strategy.
* Driving programs and initiatives for operational excellence, root cause analysis, continuous improvement and lean manufacturing.
* Interacting with executive leadership to optimize strategies and maximize efficiencies in manufacturing operations.
* Interfacing and engaging with global BioPharma clients and partners throughout Business Development, Product Lifecycle and Technology Transfer projects.
* Ensuring all plant safety policies and procedures are met in compliance with internal and external regulatory standards.
Preferred Candidate Background and Expertise:
* BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.
* 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Strong team leadership overseeing large Upstream and Downstream Manufacturing organizations and teams.
*Working knowledge of end-to-end supply chain preferred including experience with S&OP, Inventory Management, and other associated Supply Chain disciplines.
* Thorough experience with clinical and commercial manufacturing.
* Experience leading projects relating to process validation, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes within cGMP, FDA and EMA compliance.
* Active participation in regulatory inspections and up to date on compliance requirements.
*will offer full relocation