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Head of Cell Therapy Manufacturing - Full-time / Part-time
|Location||North hills, California|
About this job
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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description
About the Role:
As the Head of Cell Therapy Manufacturing, you will lead and direct the Thousand Oaks Cell Therapy Manufacturing team in the production of cell therapy products for commercial use in the US. Reporting to the Global Head of Cell Therapy Manufacturing, you will be responsible for all cell therapy manufacturing operations at Thousand Oaks. You will oversee all aspects of cell therapy manufacturing including process development, manufacturing operations, and technical transfer.
You will be an 'enterprise thinker' with an ability to collaborate and work with colleagues within the global manufacturing network, R&D and commercial functions across Takeda.
The Thousand Oaks plant operates 24 hours/day, 7 days/week.How you will contribute:
- Lead the Thousand Oaks Cell Therapy Manufacturing team and direct cell therapy Operations.
- Build and lead a team of cell therapy manufacturing professionals, providing guidance and support in the execution of their roles and responsibilities.
- Collaborate with cross-functional teams including R&D, Quality Assurance, Commercial and Regulatory Affairs, to ensure successful product launch and commercialization.
- Manage Manufacturing budgets, resource allocation and timelines to ensure delivery of high-quality cell therapy products.
- Build and implement an organizational structure that is fit for purpose. Drive organizational and individual development through talent review cycles and implementation of development plans to provide an adequate organizational structure, qualification of team members, and compliance of processes.
- Collaborate with the Global Cell therapy team in identifying and implementing process improvements to increase efficiency and reduce costs.
- Be a subject matter expert on cell therapy manufacturing for internal and external stakeholders, including regulatory agencies.
- Be the main site contact to Supply Chain and Commercial teams supplying cell therapy products from the site.
- Identify and develop potential successors for key management and expert positions.
- Drive the cell therapy manufacturing operations following OpU goals, ensure robust processes, adequate life cycle management, and optimize yields and capacity.
- Develop and execute strategic plans, goals, and targets in alignment with the GMS Network strategy and plan.
- Drive continuous improvement in operations
- Motivate and encourage the plant teams, ensure availability of job-relevant information promptly, and foster collaboration across teams/functions/partners (e.g., other plants, R&D); apply High-Performance Team principles.
- Report the status of the operations, including the defined indicators, the goals, the achievements, the gaps, and the opportunities for improvement.
- Review and approve manufacturing procedures and regulatory documents.
- Establish relationships with all internal and external stakeholders, including the Thousand Oaks Site Leadership Team, US commercial, Reg Affairs and others.
- Host inspections of cell therapy operations by third parties (e.g., inspections by notified bodies and by regulatory agencies) and assure timely implementation of commitments to regulatory agencies.
- Master's degree, preferably in science, engineering, or another related technical field. MBA preferred.
- Minimum 10 years of experience in biologics manufacturing, with at least 3 years of experience in cell therapy manufacturing (clinical or commercial environment).
- Proven track record of successful leadership and project management in a manufacturing environment.
- Experience in GMP/ISO manufacturing and handling regulatory inspections
- Experience in General Management to drive Plant performance and investments
- Continuous improvement knowledge; e.g., Black Belt/Lean/Six Sigma certification preferred
- Experience working in a matrix organization and across functions and businesses
- Comprehensive Healthcare: Medical, Dental, and Vision.
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan.
- Health & Wellness programs including onsite flu shots and health screenings.
- Generous time off for vacation and the option to purchase additional vacation days.
- Community Outreach Programs and company match of charitable contributions.
- Family Planning Support.
- Professional training opportunities.
- Tuition reimbursement.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- May work in a cold, hot or wet environment.
- May work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Base Salary Range: $165,000.00 to $ 236,000.00. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors, including, but not limited to, location, skills, education, and experience.
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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - CA - Thousand Oaks - Rancho ConejoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time