Sr. Staff Engineer

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Job Description

OBJECTIVE:

Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.

The successful candidate will be responsible for all aspects of reaction & particle engineering including the development of scale down models for the study of unit operations as well as technical transfer to external contract manufacturing organizations. He/ she will have deep experience in using process analytical technologies (PAT) in combination with mathematical models (both statistical & first principle) to enhance process understanding to effectively develop/ optimize/ scale-up and troubleshoot processes. The Senior Engineer will have experience building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes.

Be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences, will serve as a subject matter expert in one or more key areas (e.g., crystallization, reaction engineering, mixing, heat transfer, drying), provide guidance to junior engineers, and contribute to strategic initiatives to advance the organization’s process development capabilities. The role involves close collaboration with process chemistry, analytical development, manufacturing, formulation scientists, quality, and regulatory functions to ensure the successful progression of drug substance candidates from early clinical phases through to commercial launch.

The Senior Engineer will be responsible for benchmarking current trends in research, development and manufacturing technologies, developing initiating and/or participating at a high level in projects that involve extraordinary, well-considered risks along with scientific/technical challenges, as well as directing and managing outsourcing across a product platform, as appropriate. 

ACCOUNTABILITIES:

• Lead the engineering design, development, and optimization of synthetic processes for small molecule active pharmaceutical ingredients (APIs).

• Apply chemical engineering fundamentals (mass/energy balances, kinetics, thermodynamics, fluid dynamics, mixing, heat transfer, crystallization, etc.) to ensure scalability and robustness of processes.

• Plan and execute laboratory and pilot-scale studies to support process development, scale-up, and validation.

• Implement Process Analytical Technology (PAT) and Quality by Design (QbD) principles to enable process understanding and control strategies.

• Lead the technology transfer from development to cGMP manufacturing sites, ensuring process robustness and compliance.

• Partner with process chemists and manufacturing operations to solve technical challenges, and resolve technical issues during scale-up, batch execution, and validation campaigns.

• Provide on-site support at manufacturing facilities during key technical transfers, troubleshooting, and regulatory inspections.

• Identify and implement opportunities for efficiency, cost reduction, sustainability, and innovation in process development and manufacturing.

• Support the development of new tools, methodologies, and platforms to accelerate small molecule development. Contribute to the long-term capability building in areas such as digitalization, automation, and modeling/simulation.

• Identify topics for initiatives and leads local/global initiatives on behalf of senior staff.

• Own a discipline/technical skill in its entirety and continue to develop expertise in other key technical skills.  Recognized as a technical expert and resource within function. 

• Review, interpret and communicate data cross functionally within pharmaceutical sciences and project teams.

• Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences

• Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.

• Proactively identify vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.

• Provide technical mentorship, guidance, and training to junior engineers and scientists.

• Manage key vendor relationships across multiple projects as appropriate

• Represent Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.

EDUCATION, EXPERIENCE AND SKILLS:

• A Ph.D. degree with 3+ years of relevant industry experience; an MS degree with 9+ years of relevant industry experience; or a BS degree with 11+ years of relevant industry experience. Degrees in chemical engineering required.

• Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred

• Experience in building reaction kinetic models as well as process models preferred.

• Experience in building laboratory and pilot plant equipment a plus

• Experience in crystallization process development and scale-up with an emphasis on form, purity and particle size control a plus

• Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus

• Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required

• Experience in building chemometric models preferred

• Experience in developing continuous processes a plus

• Sound knowledge of current Good Manufacturing Practices (cGMP) preferred

• Experience working in a pilot plant preferred

• Previous experience with the use of contract facilities and managing technical transfers a plus

• Experience in working in a multi-disciplinary team environment

• Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts

Knowledge and Skills:

• Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions

• Teamwork - Ability to work well on global cross-functional teams.

• Communication Skills - Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with  senior management; technical writing skills to support authorship and approval of internal technical documents

• Organization - Exercises good time management and prioritization skills to balance multiple project and departmental objectives

• Technical - Subject matter expertise in a specific scientific area or areas.

• Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use

• Resource Management - Project management skills; ability to manage one’s time within individual, departmental

• External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects

• Leadership Skills - Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.

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:

Boston, MA

U.S. Base Salary Range:

$137,000.00 - $215,270.00

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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