As the Director - QC Stability & Release Testing (GMP), your basic purpose will be to ensure efficient and effective management of PPD resources. You will supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. In addition, you will plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. You will assist the division executive director in strategic planning, business development and expansion initiatives by providing mid range (1-3 month) resource utilization predictions for a department.
Note: This leadership role will be based in PPD's Middleton, WI, "best in class" GMP Laboratory.
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10-12+ years) or equivalent and relevant combination of education, training, & experience.
- Strong Global CMC experience for drug development processe.
- 5+ years of management responsibility.
- Proven leadership skills.
- driving the orders growth and financial performance of the business
- providing scientific and operational leadership in the areas of cGMP-compliant biopharmaceutical testing services that include protein characterization, biosafety, and release testing
- recruiting an experienced and talented scientific and operational team
- developing and implementing process excellence initiatives to increase productivity and quality, and decrease cost and cycle time
- develop scope of work and proposal for new and existing clients.
- work collaboratively with PPD site functions and other BP groups, to ensure that QC analytical methods are aligned with process needs/capabilities and product requirements.
- identify and address technical and validation gaps in analytical methods and implement improvements in analytical methods per ICH requirements.
- Stay up to date on new technologies and changes in CMC and other regulatory requirements
- Expert planning and tracking skills, able to see big picture, well-organized, focused onresults, capable of managing multiple projects, excellent time management with respect topriorities and self-management.
- Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective collaboration.