Shire Manufacturing 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 Ophthalmic.

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 processing facility that will bring Takeda additional cGMP capacity for fractionation, purification, filling, and packaging for its biologic medications.

The Manufacturing Lead-V position will be responsible for material system transactions, cycle count, storage room handling or management. The Manufacturing Lead – V will also be responsible for day to day scheduling of manufacturing activities including maintenance, calibrations and PM’s, validation exercises and technical studies. The incumbent has enough applied technical knowledge to perform moderate trouble shooting tasks and will assist in the execution of technical transfer activities. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

Materials Perform cycle count Monitor and report usage Perform scrap transactions Materials reconciliation during and after runs Update work-order status Assist with organizing storage rooms Maintain communication with warehouse, planners and manufacturing

Scheduling Assist Manager in Orchestrate model creation Daily updating of schedule during runs Maintain constant communication with Manufacturing Supervisors, Superintendents and Process Captains/Leads Identify windows in the schedule for activities like calibrations, PMs, equipment maintenance, validations, technical studies, etc. Work together with Maintenance Planners in proactive planning like weeks and months look-ahead. May perform other duties as assigned.

Requirements: Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties. 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 chemical and biological safety procedures. Good computer skills, knowledge of Microsoft Word and Excel. Must have demonstrated interpersonal and leadership skills 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. JDE knowledge (preferred) Orchestrate scheduling software Knowledge (preferred)

Qualifications: Requires an Associate Degree (Bachelors preferred) or equivalent with a minimum of 7 years related experience and demonstrated working knowledge of scientific principles. Pharma or biotech experience 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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Reasonable Accommodations

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.