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. Description: Experience in Albumin purification is required Prepare media and buffer solutions Operate Clean-in-Place (CIP) and Steam-in-Place systems Assemble and operate filtration systems Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc) Monitor and record critical process parameters Complete all relevant paperwork following GDP/GMP guidelines Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion Perform sampling using aseptic techniques Participate on Continuous Improvement Teams Train and mentor other team members Write, revise and review pertinent documentation as appropriate Troubleshoot process problems and respond to process alarms Assist with process/equipment validation and data analysis Work with other groups such as maintenance/metrology to ensure preventative maintenance is done Initiate and/or coordinate other process improvement projects May perform other duties as assigned Requirements: Knowledge of cGMP manufacturing Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems. Must be able to apply quantitative analysis to analyze process performance. Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills. Knowledge of basic chemical and biological safety procedures. Good computer skills, knowledge of Microsoft Word and Excel. Very good interpersonal skills and be able to work effectively and efficiently in a team environment. This position requires shift, weekend and holiday work. Overtime may be required at times. The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. May require immunization before performing work within the manufacturing area. Qualifications: Experience in a regulated production environment desirable: · Bachelor’s degree in Science / Engineering or AA or equivalent and 4+ years of experience or · High School diploma with 6+ years of experience. Must have working knowledge of scientific principles. Scientific or technical degree preferred.
Notice to Employment / Recruitment Agents:
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.