Senior Staff Engineer

Senior Staff Engineer, Process Development

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.

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.

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.

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.

Location: Lexington, MA

U.S. Base Salary Range: $137,000.00 - $215,270.00