The Technical Services Group Head will represent PDTS on the Lexington Launch Center of Excellence initiative with technical responsibility to bridge across PDTS and site functions to drive consensus. Strategic alignment across Process Development, Clinical and Commercial manufacturing will be a key success driver with the expectation to drive near term and long term projects to meet overall program goals.
The Technical Services Group Head will manage a technical services team with the focus on process installation and site activities related to new product introduction and CMC lifecycle management. The team will partner with PDTS and site functions to execute site continuous improvements to meet site targets for product transfers, site utilization, process robustness and yield.
Process Installation & New Product Introduction
Lead or manage resources for site-based product transfers and activities supporting new product introduction
- Support tech transfer teams, PDTS teams, Manufacturing, and other stakeholders to clearly define the scope of work, objectives, and deliverables for tech transfer projects.
- Establish and revise procedures/best known methods for continuous improvement (CI)
- Ensure documentation and activities are compliant with GMP, Quality procedures and Regulatory expectations
- Effectively communicate ideas, project goals and results.
- Foster teamwork, engagement and CI mindset.
- Expected to lead cross-functional projects and teams
Launch Center of Excellence
- Provide strategic vision and help shape initiatives for Launch CoE
- Translate vision and strategy to deployment with the focus on project management and execution.
- Network effectively and represent PDTS on site-based teams
- Ensure PDTS projects are resourced and managed to deliver on project deliverables and goals
- Provide leadership to drive project execution
- Communicate status and project metrics to key stakeholders including PDTS and Lexington SLT.
Education and Experience Requirements
- BS/MS Degree in Science, Engineering or related pharmaceutical field. (or an equivalent combination of education and relevant experience)
- Ten years in experience in Pharmaceutical, biotech product development or commercial manufacturing operations.
- Proven record of technical leadership, including the ability to influence, motivate, and drive technical rigor.
- Project management experience and demonstrated ability to manage large cross-functional teams
Key Skills, Abilities, and Competencies
Shire’s Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
- Strong technical leadership and direct experience in the transfer of biopharmaceutical products
- Must possess knowledge of cGMP and commercial operations.
- Effective verbal and written communication skills throughout all levels of the organization.
- Proven organizational and time management skills
- Customer service oriented
- Ability to foster a collaborative mindset with teams
Complexity and Problem Solving
- Background in OpEx including DMAIC highly desirable
- Defining and managing detailed timelines for simultaneous cross-functional efforts
- Prioritization of deliverables from complex projects
- Good understanding of manufacturing capabilities and process technologies
- Ability to understand technical details and product specific requirements
Location/Region: Lexington, MA