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Job Description

About the role:

As the Head of External Site Operations, you will be responsible for overseeing the conversion of raw materials and components into finished goods. This role ensures the efficiency and quality of production processes, contributing to the overall success of Takeda's manufacturing operations.

How will you contribute:

• Manage existing supplier relationships, including the day-to-day management, Business Review meetings and support contractual negotiations.

• As a CMO management expert, provide leadership and support for RFP's, technical transfer activities, and deviations, investigations, CAPA and change control for global commercial biologic Drug Substance/Drug Product / Finished drug product manufacturing.

• Work with Takeda stakeholders to develop and monitor short-term and long-term plans, including timelines, budget forecasts, for achieving department strategies.

• Independently negotiate (with Procurement and legal support) moderate scope manufacturing supply agreements/SOW’s meeting Takeda supply, quality, financial and risk mitigation requirements.

• Identify, elevate, and work with Takeda stakeholders and CMO’s to facilitate resolution of manufacturing, analytical, supply chain, quality, or issues that may arise.

• Monitor and drive adherence to Takeda’s and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.

• Utilize ESOT / Tier 3 standard governance for CMO oversight.

• Establish track, monitor, and report performance metrics related to operations, quality, cost, and customer service per agreed OpU KPIs. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.

• Experience in management of internal and CMO Manufacturing and Quality deviations, changes, process yield issues and any technical issues that may arise during production and testing of commercial products at CMOs.

• Experience in global product launches and the associated CMC regulatory requirements.

• Strong business and functional knowledge of biopharmaceutical and/or pharmaceutical Operations, Process. Development, Finance, Supply Chain Management, Regulatory Affairs, Quality Assurance, and Quality Control.

• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.

• Strong technical, interpersonal, communication and leadership skills.

• Strong organizational and strategic thinking skills.

• Demonstrated organizational skills including project and budget management.

• Demonstrated ability to anticipate and address conflicts or issues in timely manner that supports long term success of the organization.

• Demonstrated success in technical proficiency, scientific creativity, and independent judgment. Works on complex problems which require in-depth analysis and collaboration with others and exercises judgment within broadly defined procedures and practices. Determines methods and procedures on new assignments and provide guidance to all colleagues. Thinks broadly and identifies opportunities and develops solutions that impact beyond their role/function.

• This role requires a significant wide-spectrum understanding of pharmaceutical manufacturing and the associated requirements. Support ongoing development plans, devise improvements and outline opportunities for success under tight timeframes. 

• The candidate must be able to successfully interpret sometimes incomplete information and design cost effective opportunities to fill gaps.    

• Deal with a wide range of problems that require complex judgments and innovative solutions in order to meet the needs of both Takeda Product Teams and the external suppliers.

What you bring to Takeda:

• Requires a degree in a scientific/technical discipline with 10 years technical and managerial industry experience in development and/or manufacturing, ideally within the Biologics area. 

• Demonstrated experience in external manufacture management across drug substance, drug product and finished drug product.

• Ten or more-year experience in organization management including responsibility for budgets, resource allocation and project portfolio management.

• Proven and demonstrable negotiation skills in all categories of direct spend, effectively leading, communicating and influencing others to accomplish challenging tasks.

• Proven ability in managing cross-functional teams.

• Recognize the importance of meeting business needs and balance cost, quality and customer service.

More about us:

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.

#GMSGQ 

#ZR1

#LI-MA1

#LI-Hybrid

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$153,600.00 - $241,340.00

EEO Statement

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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