Head of Manufacturing, Purification

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Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

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Job Description

This 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 Sigma

Education 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.

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.

Check out where you could be
working if you apply.

Job Seekers: Protect yourself against identity theft

Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.

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