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Shire Head of Network Support Lab in Social Circle, Georgia
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,
Lead the Technical Services Laboratory for support of Covington manufacturing and the Global Wet Lab network. Recruit and train the TS Laboratory staff of Scientists and Engineers. Guide team members in the initiation of studies and improvement projects for product quality, process robustness, product yield and cycle time based on recent technical knowledge. Support commercial manufacturing operations to meet fulfillment targets (lot release timing). Complete CAPA tasks to ensure on time release of lots; product impact assessments, corrective and preventive actions and root cause investigations as needed. Manage the laboratory area and group to ensure readiness of all instrumentation and equipment, supplies, consumables, and procedures for a safe, efficient and compliant Tech Services laboratory.
Understand and integrate information from multiple disciplines and apply it to solving complex problems using Lean/Six Sigma and related variation reduction techniques. Manage, identify, hire, develop and recognize technical staff; create and maintain employee and organizational development; as well as HR plans which meet business needs. Participate in and/or lead global task forces and committees to address technical, quality and continuous improvement and harmonization initiatives. Identify and fulfill documentation requirements that support product licensing approvals. Approve protocols and support documentation in order to support regulatory licensure of the facility. Develop staff members to assume technical approver role.
Knowledge of GMPs, FDA guidelines and
process validation. Must be self-motivated, have good interpersonal skills,
capable of analyzing and solving complex problems through
innovative thought and experience. Ability to manage multiple cross-functional teams
simultaneously. Ability to design and influence outside of immediate scope of responsibility. Maintain industry contacts and be involved in industry interest groups. Proven track record of management/leadership effectiveness.
BS in relevant engineering or physical science discipline, advanced degree preferred, 6 years experience in pharmaceutical, biotechnology or related industry.
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.