US-GA, Material Qualification Lead SR0029873-MZ
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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