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Associate Director Process Engineering, Process Chemistry and Development

Bio-Life Plasma, LLC

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Process Chemistry & Development (PCD) 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.

Join Takeda as an Associate Director Process Engineering in our Process Chemistry & Development team. You 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. You will have deep experience using process analytical technologies (PAT) in combination with mathematical models (both statistical and first principle) to enhance process understanding to develop/ optimize/ scale-up and troubleshoot processes. You will have experience with building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes.

How you will contribute:

  • You will be striving 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 as well as robotics and/ or cobotics.

  • You will be recognized as a technical resource/expert within PCD and across Pharmaceutical Sciences and utilize technical expertise to contribute across multiple projects and drive technical/scientific strategy.

  • You will collaborate closely with the Chemistry and Manufacturing Sciences & 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.

  • You 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.

  • Lead a group of Engineers responsible for supporting Takeda's synthetic molecule pipeline.

  • Develop project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department.

  • Develop and manages strategies for projects and executes complex experimental protocols.

  • Have full accountability for all engineering aspects for multiple pipeline projects.

  • Initiate complex projects with extraordinary technical challenges and applies strong technical risk assessment skills.

  • Own a discipline/technical skill in its entirety and continue to develop expertise in other key technical skills.

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

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

  • Conduct analysis of technical and conceptual risk, identify trends and defines and champions process or scientific strategies.

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

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

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

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

  • Lead small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions.

  • Identify topics for initiatives and lead 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.

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

  • Make proposals regarding sourcing/consultancy strategy.

  • Lead technology transfer to internal or external manufacturing sites or vendor

  • Communicate with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes.

  • Author relevant sections of regulatory documents, validation plans, reports and pier reviewed manuscripts.

  • Define outsourcing strategy for department in conjunction with senior staff.

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

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

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

Minimum Requirements/Qualifications:

  • 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.

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

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time