Head of Manufacturing, Purification

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionThis position reports to the Site Head (VP, Manufacturing) and is responsible to lead a cross-functional Purification Manufacturing team to deliver high-quality products, safely and consistently on time, at the most competitive cost, and in compliance with local and global regulatory requirements. Partner with other functions like EHS, Quality, Engineering, Supply Chain, and Manufacturing Sciences to drive continuous improvement in safety, quality, fulfillment, capacity, cost, and project execution.Essential Duties and Responsibilities* Responsible for safety leadership and culture for Purification organization with a focus on employee safety, environmental exposures and identifying potential serious issues proactively.* Responsible for compliance with all regulatory policies. Implements current Good Manufacturing Practices (GMP) consistent with Corporate requirements.* Responsible for Purification manufacturing of multiple products in multiple suites at the facility which operates seven days a week, 24 hours a day. Responsible for Purification manufacturing with three purification suites (small, mid and large scale) composed of cleanrooms, automated process control, EBM and a variety of purification methods including MAb, UF/DF, NF and TFF skids.* Ensures organization adheres to policies and procedures governing environmental, health, and safety, requirements.* Accountable for delivering quality products in a timely manner at the most competitive cost to the Corporation. Effectively communicates production status with downstream customers.* Responsible for defining near-term and long-term strategic plans for extended organization. Implements required actions, staffing plan and organizational development to deliver committed results.* Champions and implements a culture of operational excellence that leverages lean manufacturing principles.* Develops annual operating budget and executes all operational activities to meet or beat financial plan. Accountable for developing and implementing a 3-5-year manufacturing strategy to address safety, quality, product yields, and financial outcomes.* Regularly interacts with leaders from Quality, Engineering, Supply Chain, Manufacturing Sciences, and other Sites to resolve issues, drive improvement activities, and prioritize initiatives and resources.* Develops self, direct reports, and high potential employees. Manages a team of 2-3 direct reports and ~150 indirect reports.* Key member of Site Senior Leadership Team (SLT).Qualifications* Ability to manage activities of departments through subordinate managers who exercise full supervision in terms of cost, methods, and employees.* Ability to interpret and analyze statistical data and financial reports, understand, and resolve technical difficulties, interface with internal and external engineering/technical experts, and manage multiple priorities in a manufacturing environment setting.* Demonstrated leadership skills, including sponsoring/leading high performing cross-functional teams* Excellent communication and presentation skills, both oral and written, with a demonstrated ability to present key quality/department/business indicators to senior management.* Ability to drive change and motivate others toward a common vision* Excellent facilitation, problem-solving, and analytical skills* Must be confident, resourceful, creative, self-reliant, and self-motivated.* Understanding of global cGMP regulations and quality management systems for pharmaceutical or biotechnology operations, including participation in regulatory inspections* Excellent interpersonal, influencing, and negotiating skills.* Strong project management, organization, and planning.* Excellent working knowledge of world-class manufacturing techniques, including Lean and Six SigmaEducation and/or experience* Requires a bachelor’s degree, preferably in Science, Engineering, or other related technical field. Master’s Degree preferred. 10+ years of related experience with 7+ years of experience in a Biopharmaceutical/Pharmaceutical in a management/manufacturing leadership role.* Must have previous relevant experience leading manufacturing operations with a proven track record of success in leading complex organizations.* Experience in Lean Manufacturing and DMAIC, with a proven record of driving operational improvements.Physical Demands* In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.Working Environment* Must be able to work in controlled environments for 3-5 hours requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.* No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.* May work in a cold, wet environment* Must be able to work as needed to cover multiple shifts, including weekends.* May be required to work in a confined area.* Some Clean Room and cool/hot storage conditions.LocationsUSA – CA – Los AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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