Shire operates the Los Angeles plant which performs fractionation and purification of human plasma to safely produce quality therapies that save and sustain lives. The facility has evolved over the last six decades through expansions, upgrades and increases in output. In order to maintain a reliable supply of therapies for patients, Shire manages projects to improve manufacturing and auxiliary processes on a continuous basis. These projects executed locally at the Los Angeles plant and globally throughout the Technical Operations organization.
Essential Duties and Responsibilities
- Responsible for performance and oversight of project portfoliosupporting AHF-M Manufacturing including capital budgeting, monthly cash-flow updates, and project status reviews.
- Develops and implements strategy to achieve site objectives and production ramp-up targets
- Provides clear direction on product/process development requirements and facility/equipment upgrades required to meet expectations of customers and stakeholders.
- Leads the team in defining program strategies and goals, and assigns/manages project tasks to ensure the project team meets all commitments.
- Sets the project strategy, schedule, aligns resources and provides ongoing analysis of financial and schedule performance.
- Communicates project status updates to all levels of management.
- Develops and manages team deliverables required for successful project completion
- Provides technical support for all project phases; product/process development, project execution and transition into manufacturing.
- Anticipates and resolves conflict situations to ensure win-win outcomes.
- Must manage all project requirements including engineering design, equipment evaluation and procurement, contractor selection and coordination of all project resources to ensure successful project execution, validation and handover to manufacturing.
- Must be willing to work evenings and weekends, as required, to oversee project activities.
- Drives use of Shire’s Project Management Methodology throughout Projects
- Demonstrates a commitment to continuous improvement of PMO business processes
- Must be well versed in Project Management tools and must possess knowledge of related disciplines. Must have knowledge of such principles as GMPs, FDA guidelines and purchasing practices. Experience with commissioning and validation concepts, procedures, protocols and requirements to support GMP are required. Understanding of Critical Systems, facilities, and logistics process and project implementation experience a definite plus
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
- Ability to manage multiple cross-functional teams simultaneously.
- Ability to design and implement projects/studies outside area of expertise. Must demonstrate strategic leadership, strong financial acumen, and proficient supervisory skills. Display ability to communicate effectively using a wide variety of skills and vehicles.
- Ability to work in a fast paced or challenging work environment.
Education and/or experience
Bachelor’s degree in Engineering or Science is preferred. PMI certification is preferred. Minimum of 5+ years of related experiencerequired, 3+ years of project management experiencerequired. Experience in FDA regulated environment highly preferred.
- Must be able to lift, push, pull and carry up to 10 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Normal office environment.
- May be required to travel for business reasons. e.g. training and meetings.
- Must be able to work in controlled or clean room environments requiring special gowning. Would be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
- May be around moving equipment and machinery.
- Inside working conditions.