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Shire Material Qualification Lead in Social Circle, Georgia
Takeda 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.
Ensure validation master plans comply with Takeda and regulatory agency requirements. Develop material qualification strategies and protocols for material changes. Provide project management for material qualification execution. Support development of best demonstrated validation practices within the Engineering Validation Department, based on current industry practices and guidelines. Support continuous improvement within the Engineering Validation Department. Support regulatory submissions and regulatory agency inspections as required. Represent Takeda Engineering Validation Department to industry as required. Serve on divisional teams as required. Assist with preparation of regulatory filings, with answering questions from health authorities, and with presentations of materials during regulatory inspections/partner audits, as applicable and as related to the assigned programs. Development and implementation of SOPs/Guideline documents with systemic procedural improvements related to process validation and associated activities. Determine methods and procedures on new assignments with oversight from project leadership team. Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by Takeda, validation techniques/approaches and systems utilized at Takeda. Identifies and implements improvements to the Engineering Validation systems (department level impact).
Ability to work effectively with multi-department and multi-site teams Ability to manage and organize complex technical problems Good written and oral communication skills, excellent attention to details Strong team leader with management skills and focus on results Strong scientific analysis and troubleshooting skills Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes
Qualifications: Ideal candidate will have a Ph.D. in inorganic or organic chemistry, material science, or related field. Minimum BA or BS degree preferably in the engineering or science field. Minimum 7 years validation experience for non manager role; 5+ years experience for Supervisor
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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, a wholly-owned subsidiary of Takeda, 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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.