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Lead New Modalities, MfgX

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **www.astellas.com** .

The Role:

The New BioManufacturing POD Lead is responsible for driving digital transformation initiatives within the BioPharma Manufacturing division of Astellas Pharma. This role develops and oversees the implementation of a digital solutions roadmap, aligning with strategic business objectives to enhance operational efficiency and innovation. The position requires close collaboration with BioPharma Manufacturing leadership to identify technical needs across the division and develop tailored solutions to address those needs effectively. Additionally, the role fosters strong relationships with stakeholders across the manufacturing network, ensuring alignment and engagement in digital transformation efforts.

This position is accountable for planning, managing, and executing digital projects that deliver measurable business impact. The New Modalities POD Lead serves as a key escalation point for IT-related issues at BioPharma Manufacturing plants, working closely with cross-functional teams to resolve challenges and continuously improve digital capabilities. By leveraging expertise in manufacturing technologies, project management, and stakeholder engagement, this role plays a critical part in advancing Astellas’ digital strategy and enhancing manufacturing operations.

Responsibilities and Accountabilities:

+ Lead the New Modalities POD, adhering to an Agile operating model by identifying and staffing Value Teams and ensuring the seamless execution of Agile frameworks, including Scrum ceremonies, sprint planning, retrospectives, and continuous backlog management to drive efficiency and innovation.

+ Leads a team of approximately 5 or more direct reports, overseeing MFGX operations and the deployment of digital solutions.

+ Serves as an active participant on the BioPharma Manufacturing Leadership Team, contributing to strategic decision-making and digital innovation initiatives.

+ Holds a key role on the MFGX Leadership Team, ensuring alignment between digital transformation efforts and broader manufacturing objectives.

+ Develop and implement the digital transformation roadmap for BioPharma Manufacturing, aligning with business objectives and industry advancements.

+ Engage with BioPharma Manufacturing leadership to identify technical needs and recommend digital solutions that drive operational efficiency.

+ Establish and maintain strong stakeholder relationships across the manufacturing network to ensure alignment and collaboration on digital initiatives.

+ Lead and oversee the execution of digital projects, ensuring they are delivered on time, within scope, and meet business requirements.

+ Build, develop, and mentor a high-performing team, fostering a culture of innovation, collaboration, and continuous learning.

+ Manage budgets for digital transformation initiatives, ensuring cost-effective allocation of resources and alignment with business priorities.

+ Act as the primary escalation point for IT-related issues at BioPharma Manufacturing plants, facilitating issue resolution and continuous improvement.

+ Collaborate with cross-functional teams, including IT, Operations, and Engineering, to drive adoption and successful deployment of digital solutions.

+ Monitor emerging technologies and industry trends to identify opportunities for innovation and efficiency improvements in manufacturing.

+ Develop business cases and proposals to secure investment and resources for digital initiatives.

+ Ensure compliance with regulatory, security, and data governance standards when implementing digital solutions.

+ Support change management and training efforts to drive user adoption and maximize the impact of digital transformation initiatives.

Required Qualifications:

+ Bachelor’s degree in computer science, Information Technology, Engineering, or a related field.

+ 10+ years of IT leadership experience, with at least 5+ years in biomanufacturing, pharmaceutical, or regulated manufacturing environments.

+ Proven experience in leading digital transformation and IT strategy within manufacturing operations.

+ Strong understanding of IT Service Management (ITSM) frameworks, including ITIL, and experience with IT governance, risk, and compliance (GRC).

+ Expertise in manufacturing execution systems (MES), enterprise resource planning (ERP) systems (e.g., SAP), and industrial automation technologies.

+ Knowledge of cloud computing, cybersecurity, data analytics, and AI/ML applications in manufacturing.

+ Familiarity with 21 CFR Part 11, GAMP 5, and other regulatory requirements governing IT systems in life sciences.

+ Proven ability to develop and execute IT strategies that drive operational efficiencies and align with business objectives.

+ Strong leadership skills with experience managing cross-functional teams, IT budgets, and fostering innovation.

+ Excellent communication and stakeholder management skills, with the ability to collaborate effectively across senior leadership, regulatory teams, and manufacturing operations.

Preferred Qualifications

+ Master’s degree (MBA, MIS, or related field).

+ Experience leading large-scale digital transformation initiatives in a biomanufacturing or life sciences environment.

+ Knowledge of advanced data analytics, predictive maintenance, and AI-driven manufacturing solutions.

+ Prior experience working with Industry 4.0 technologies, including IoT, digital twins, and smart factory solutions.

+ Familiarity with Lean, Six Sigma, and other continuous improvement methodologies in IT and manufacturing.

Working Environment

+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

**Salary Range** : $168,700 - $265,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

**Benefits** :

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Company fleet vehicle for eligible positions

+ Referral bonus program

_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._

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Category MFGX

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans