Associate Director, Process Engineering

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Objectives:

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

The successful candidate will be responsible for leading a group of Engineers responsible for all aspects of reaction & particle engineering including the development of scale down models for the study of unit operations, process safety evaluation as well as technical transfer to external contract manufacturing organizations. The ideal candidate 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 Associate Director will have experience with building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes. The ideal candidate will strive to continuously improve how pipeline projects are supported and will be developing new workflows to facilitate and accelerate process development, optimization and understanding as well as technical transfer to manufacturing, leveraging digital tools, automation, robotics and/ or cobotics.

The successful candidate will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize his/ her technical expertise to contribute across multiple projects and drive technical/scientific strategy. The Associate Director will be collaborating closely with the Chemistry and Technology groups to apply enabling & emerging development and manufacturing technologies, and will be responsible for helping shape the department’s technology roadmap, based on pipeline needs and current trends in research. The successful candidate will be responsible for maintaining and growing the department’s strategic relationships with our outsourcing partners as well as directing and managing outsourcing across a product platform, as appropriate.

Accountabilities:

• Leads and manages a group of Engineers, providing technical guidance, mentoring, and performance management to ensure the team's success and professional growth.

• 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 multiple 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.

• Contributes significantly to develop, drive and set the vision and direction of departmental activities, management of resources, time, personnel and financial resources. Maintains ownership of overall vision of scientific platform.

• Communicates and coordinates implementation of technology/scientific improvement to senior management, across therapeutic and scientific areas.

• 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.

• Incorporates novel manufacturing, technologies and industry trends as a key aspect of scientific strategy development.

• Maintains complete technical responsibility for program(s)/initiative(s) within the department.

• Leverages cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in technical aspects.

• Ensures effective project management of all plans and projects within area of responsibility, linking all scientific efforts to company, program and functional goals.

• 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.

• Contributes to departmental strategy around scientific improvement and new capabilities.

• Makes proposals regarding sourcing/consultancy strategy.

• Coordinates and leads technology transfer to internal or external manufacturing sites or vendor

• 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.

• Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.

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

Education and Experience:

Required:

• A Ph.D. degree with 7+ years of academic or 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 managing staff 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 will late stage filings.

• 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 express oneself 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. Demonstrated ability to successfully contribute across multiple scientific endeavors

• 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, and corporate goals and timelines; management of internal and external resources (vendors)

• 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.

Travel Requirements:

May require approximately 10% travel

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

Location: Cambridge, MA - Hybrid

Base Salary Range: $160,000 - $205,000

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.