Associate Engineering Fellow Process Engineering

Takeda Pharmaceutical is seeking a highly skilled Associate Engineering Fellow to join our Synthetic Molecule Process Development (SMPD) team. As a key member of our team, you will be responsible for developing robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals.

The successful candidate will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences, utilizing their technical expertise to contribute across multiple projects, drive technical/scientific strategy, and mentor junior engineers. You will lead complex programs and be responsible for all aspects of reaction & particle engineering, including the development of scale-down models for the study of unit operations, process safety evaluation, and technical transfer to external contract manufacturing organizations.

Key Responsibilities:

• Develops project and/or significant technical strategy and leverages technical skill(s) as a resource/expert within the department.
• Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies.
• Drives process optimization initiatives to improve sustainability, process efficiency, yield, quality, and cost-effectiveness, utilizing expertise in process chemistry and fundamental engineering principles.
• Oversees process scale-up activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation.
• Has full accountability for all engineering aspects for complex pipeline projects.
• Initiates complex projects with extraordinary technical challenges and applies strong technical risk assessment skills.
• Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.
• Conducts analysis of technical and conceptual risk through robust process characterization, failure mode analysis, and risk assessment methodologies, identifies trends, and defines and champions process or scientific strategies.
• Benchmarks current trends in R&D and manufacturing technologies.
• Incorporates novel manufacturing, technologies, and industry trends as a key aspect of scientific strategy development.
• Leads small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions.
• Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff.
• Recognized as a technical leader/resource by the group and fosters development of technology skill sets within department and among junior staff.
• Acts as a mentor to junior staff.
• Leads the development of novel solutions for complex cross-functional data analysis, modeling, and engineering challenges.
• Contributes to departmental strategy around scientific improvement and new capabilities.
• Coordinates and leads technology transfer to internal or external manufacturing sites or vendors.
• Communicates with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes.
• Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), process descriptions, and peer-reviewed manuscripts.
• Defines outsourcing strategy for department in conjunction with senior staff.
• Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver against pipeline goals.
• Attends pertinent workshops and conferences. Belongs to a national professional society, actively participates in local and national activities. Presents scientific posters or podiums internally and externally to Takeda. Authors internal reports of publication quality and co-authors publishable manuscripts. Represents Takeda in relationships with universities and industrial consortia. Is an inventor on invention disclosures and patents. Authors publications. Contributes to and drives publication strategy within department. Establishes recognition as scientific leader within Takeda.

Requirements:

• A Ph.D. degree with 7+ years of pharmaceutical industry experience; an MS degree with 13+ years of pharmaceutical industry experience; or a BS degree with 15+ years of pharmaceutical industry experience. Degrees in chemical engineering required.
• Extensive experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred.
• Extensive experience in building reaction kinetic models as well as process models preferred.
• Extensive experience in building laboratory and pilot plant equipment preferred.
• Experience in crystallization process development and scale-up with an emphasis on polymorph, 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 preferred.
• 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).
• Experience working in a pilot plant a plus.
• Previous experience with the use of contract facilities and managing technical transfers.
• Experience in working in a multi-disciplinary team environment.
• Significant technical and strategic leadership and accomplishments.
• Previous experience contributing to regulatory filings, preferably experience with late-stage filings.
• Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts.

Knowledge and Skills:

• Able to troubleshoot critical issues or problems and determine the causes and possible solutions.
• Ability to work well on global cross-functional teams.
• Ability to express oneself clearly and concisely within teams; documents issues and/or concerns concisely and comprehensively; adjusts communication style as appropriate for the audience timely and effectively communicates with senior management; technical writing skills to support authorship of internal/external and approval of internal technical documents.
• Excellent time management and prioritization skills to balance several project and departmental objectives.
• Recognized specialist in defined scientific area or areas.
• 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.
• Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events and communicating new scientific trends. Interacts with external vendors for projects.
• Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.

About Us:

Takeda Pharmaceutical is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are certified as a Global Top Employer and strive for excellence in everything we do. Our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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 strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

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. 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. 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.

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