Description Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for fractionating, purification, and fill and finish for its biologic medications. This position will play a key role in start-up operational readiness and supporting manufacturing operations in areas like raw materials and consumables onboarding, materials management logistic definition, JDE operational design, and manufacturing scheduling.
• Specify production work order builds for materials resource planning system
• Ensure availability of all materials and consumables
• Support the implementation of Kaizen, Kanban and 6S systems to assist from CQV to Full production environment.
• Revise existing or initiate new SOPs, Job aids, and Structured on the Job Training (SOJT) associated to material inventory, handling, and manufacturing scheduling process.
• Maintain records of materials in inventory and on order. May be designated a lead worker within the inventory or scheduling group.
• Work with inventory analyst to schedule, coordinate, and execute material transfers that include non-hazardous, hazardous and flammable chemicals to support manufacturing schedule adherence.
• Analyze and reverse material transfer plans as required.
• Containment of issues as they arise on shift and effective escalation of issues as needed.
• Independently develop schedules for manufacturing using system tools.
• Partner with supply chain planning to understand demand forecast and determine appropriate production plans.
• Manage reporting tools and metrics that support department and team goals.
• Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS). Understand and follow Job Hazard Analysis (JHA) packets.
• Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
GD123 Qualifications Education and/or Experience:
• Bachelor of Science degree required (prefer Operations, Logistics, Science, or similar degree)
• Minimum five years relevant professional (GMP industry) experience required
• Demonstrated ability to perform in a high performing workforce
• JDE or equivalent ERP (enterprise resource planning) system knowledge preferable
• Must have scheduling experience. (Experience with Orchestrate planning tool is a plus)
• Must have experience with inventory management.
• Experience in handling pallet-jacks, pallet trucks, and forklifts desired.
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Self-driven individual that requires minimal supervision
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel, PowerPoint, and Project).
- Ability to prioritize in a fast paced environment.
- Basic knowledge of lean manufacturing systems (Ex. Kaizen, Kanban, 5S).
- Must have customer services and leadership attitude to take ownership of any material transfer related problem.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must demonstrate importance of working in a regulated environment.
Equal Employment Opportunity
- May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry).
- May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
- May be required to work weekends, evenings, off-hours, extended periods of time.
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.