Job Description

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Job Description

Title: Senior Manager, Commercial Biologics Product Science Lead

Location: Lexington, MA / Zurich, Switzerland

About the role:

Join Takedas global Biologics Product Sciences team and become a member of the global team of product science experts responsible for product knowledge for Takedas large and diverse commercial biologics portfolio. In this role, you will be a senior subject matter expert across one or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. Through your deep product and process understanding you will shape CMC and program strategy and ensure robust control strategies to the benefit of patients worldwide.

How you will contribute:

• Build and maintain a comprehensive understanding of product structure, critical quality attributes, impurities, stability and structurefunction relationships.

• Define and justify product specifications using process and analytical history, ensuring consistency across sites and over the product lifecycle.

• Design and own analytical comparability strategies and nonGMP analytical methods for assigned products.

• Lead preparation and review of CMC dossier sections related to product quality, characterization and analytical control strategy.

• Provide technical leadership for complex investigations and cross-site initiatives affecting product quality, driving alignment and timely decision-making.

• Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical Sciences, Global Manufacturing Sciences and Quality.

• Ensure effective product knowledge sharing across sites and functions to support reliable commercial supply.

• Influence stakeholders across functions and regions to resolve complex issues, balancing patient, quality, business and regulatory considerations.

• Mentor colleagues and contribute to the development of future talent in biologics product sciences.

What you bring to Takeda:

• Degree in Engineering, Life Sciences, or closely related area

• B.Sc. with a minimum of 10 years of experience in a pharma/biotech environment; an advanced degree (M.Sc. or PhD) is preferred.

• Deep expertise in analytical methods and characterization for biologics with capability and interest in analyzing and solving complex problems through innovative thought and experience.

• Experience with activities associated with commercial launch and release as well as interactions with Health Authorities to support submissions.

• Experience operating globally in a matrixed organization would be greatly appreciated.

• Clear, concise communication skills, with the ability to convey complex concepts in writing and in person to technical and non-technical audiences.

• Fluent English required; proficiency in verbal and written Mandarin is beneficial but not required.

• Demonstrated enterprise mindset, strong prioritization and quality focus.

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:

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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, MAVienna, Austria

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job Tags

Minimum wage, Full time, Temporary work, Local area, Worldwide,

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