Senior Staff Engineer

Takeda; Lexington (AL); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda in Lexington, MA is seeking a Senior Staff Engineer, Process Development to lead downstream bioprocess development, scale-up, and technology advancement for robust, compliant manufacturing of biotherapeutics. You will shape process strategies, automation, PAT, and digital solutions while collaborating across development, manufacturing, quality, regulatory, and external partners.

The role demands advanced data analytics, process modeling, and cross-functional leadership, with a focus on

Qualifications

• Bachelor’s with 11+ years, or Master’s with 9+, or PhD with 3+ years.
• Extensive experience in cGMP pharmaceutical development for APIs and/or drug products.
• Strong knowledge of cGMP practices and regulations.
• Excellent leadership, communication, and collaboration skills.
• Expertise in data analytics, process modeling, automation, PAT and digital tech.
• Proven success mentoring scientists/engineers and managing external partners.

Responsibilities

• Lead downstream bioprocess development, optimization, and scale-up.
• Define strategies for process design, automation, PAT, and tech uptake.
• Develop robust purification, filtration, chromatography, and viral clearance processes.
• Solve complex technical challenges with data-driven approaches.
• Mentor colleagues and lead cross-functional teams.
• Communicate strategies and results to leadership and stakeholders.

Skills

CMC development

cGMP knowledge

Technical leadership

Cross-functional collaboration

Data analysis

Process modeling

Automation

PAT

Digital infrastructure

Education

Bachelor’s degree

Master’s degree

PhD

Job description

Job Description

About the Role:

Takeda is seeking a Senior Staff Engineer, Process Development to provide technical leadership in the development, optimization, scale-up, commercialization, and technology advancement of downstream bioprocesses. This role will help shape platform strategies, process intensification, automation, process analytical technology (PAT), and digital solutions that enable robust, scalable, compliant, and efficient manufacturing of biotherapeutics.

The successful candidate will serve as a recognized technical expert, lead cross-functional initiatives, and collaborate with development, manufacturing, quality, regulatory, business, and external partners to deliver innovative process solutions.

How you will contribute:

• Lead downstream bioprocess development, optimization, scale-up, commercialization, and technology development.
• Define strategies for process design, intensification, automation, PAT, and implementation of emerging technologies.
• Develop and characterize robust processes involving purification, filtration, chromatography, viral clearance, formulation, and related unit operations.
• Solve complex technical challenges through innovative, data-driven approaches and methodologies.
• Serve as a subject-matter expert across multiple downstream processing technologies.
• Advance digital infrastructure, advanced data analysis, and process modeling capabilities.
• Manage external partnerships, vendors, and technology providers in support of project objectives.
• Mentor colleagues and strengthen team capabilities in a collaborative, development-focused environment.
• Ensure alignment with business, manufacturing, quality, regulatory, and product development objectives.
• Communicate technical strategies, results, risks, and recommendations to cross-functional stakeholders and leadership.

What you bring to Takeda:

• Bachelor’s degree with 11+ years of relevant industry experience; or
• Master’s degree with 9+ years of relevant industry experience; or
• Ph.D. with 3+ years of relevant industry experience.
• Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and/or drug products in a cGMP environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP).
• Demonstrated experience working effectively in multidisciplinary teams.
• Excellent technical leadership, communication, problem-solving, and
• collaboration skills.
• Expertise in advanced data analysis, process modeling, automation, PAT, process intensification, and digital infrastructure development preferred
• Proven success leading technology implementation and cross-functional programs, mentoring scientists and engineers, and managing external collaborators would be ideal.

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

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.

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. 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.