Sr. Director, Head of Process Engineering
Job Location:
Cambridge, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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OBJECTIVE:
Synthetic Molecule Process Development (SMPD)is responsible fordeveloping robust sustainable and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals ensuringhigh standardsof quality safety and scalability.
The Sr. Director ofProcessEngineeringwillbe responsible fororganizational leadershipforglobalProcess Engineering team within SMPDandfordrivingglobalfunctional area strategy.Accountable for the performance and results ofglobal Process Engineeringgroup; strategic influence across Takeda Business Units and/or with external collaborators.Responsible for identification and application of relevant industry trends to inform operational strategy with an emphasis on enterprise leadership ensuringsuccess for current and future programs withinProcess Engineering and SMPD broadly.RepresentsTakeda externally and drives external collaboration network strategy.Provide strategic and technical leadership for the global process engineering group driving process design optimization and technology transfer for small molecule drug substance unit operations for the full development lifecycle from pre-IND to PPQ and Commercial tech transfer. The successful candidate will be accountable forestablishinglong-term technical vision building organizational capability and ensuring alignment with both pipeline needs and broader organizationalobjectives.
ACCOUNTABILITIES:
Defines the long-term vision and strategic roadmap forSMPDglobalprocess engineering capabilities ensuring alignmentacross SMPD departments and Pharm Sci functions as well as other business units (Quality Regulatory GSQ).
Accountable for the performance and results of global team including performance management talent development succession planning and building organizational capability across global regions.
Accountable fordevelopment and manufacturing offull synthetic moleculedevelopmentin terms ofleveragingprocess engineeringexpertiseeither directly or through leadership of team members
Establishes and manages operational processes acrossglobal Process Engineeringwithinglobal SMPD.
Has full accountability for all engineering aspects forsmall moleculepipeline projects.
Directsteam members inprocess development and optimization for key unit operations including reaction engineering crystallization particle engineering separations and drying.
Overseesdesign qualification and operation of laboratory scale-down models to enable robust process scale-up.
Develops and oversees strategies forglobal Process Engineeringinfrastructure resources projects etc. and implementsrelevanttechnologies and innovations.
Manages performance personnel issues and communication effectivenesswithin global Process Engineering
Accountable for the development of organizational culture and capabilities withinglobal Process Engineering and global SMPD.
Defines and ownssourcingstrategy forprocess engineering developmentand contributes materially and may own aspects of overall strategy forsynthetic molecule development and manufacture.
Contributes to wider cross Business Unit strategyparticularly with respect to Commercial (GSQ) development and manufacturing
Engagesfrequentlywith leadership of SMPD departments and Pharm sci functions and other business units (Quality Regulatory and GSQ) to ensure investigational synthetic moleculeengineeringstrategies are aligned at the operational workflow Project and Portfolio levels where relevant.
Identifiesand elevates awareness of topics for initiatives with impact across R&D/cross-divisionalorganization.
Leads complex interdisciplinary initiatives and may sponsor a cross-departmental or cross-functional initiatives
Advises CMC teams on impact of team actions on other projects in their functional area and vice versa.
Utilizes technicalexpertiseto contribute toR&D/cross-Business Unit strategy to solve complex issues.
Accountable for relevant technical content in regulatory filings (IND NDA MAA) and health authority queries.
Establishes and enforces best practices in process safety quality by design (QbD) and risk management.
Buildsandsustainsstrategic relationships with academic partners consortia and vendors to accesscutting-edgescience and capabilities.
Maintains external visibility and thought leadership through publications invited talks and representation in industry working groups.
EDUCATION EXPERIENCE AND SKILLS:
Bachelors degree in Chemical Engineeringand25 years relevant industry experience;Masters degree in Chemical Engineeringand21 years relevant industry experience; PhD in Chemical Engineering and 15 years relevant industry experience.
Extensive experience in small molecule process development scale-up and commercialization.
Direct experience working in a manufacturing facility or pilot plant environment with a strong understanding of cGMP operations technology transfer and scale-up.
Demonstrated leadership in facility design start-up or expansion projects including defining user requirements equipmentselection and commissioning.
Demonstrated success in leading teams and managing technical staff.
Strongtrack recordof contributions to regulatory filings (IND/IMPD NDA MAA) including late-stage submissions.
Significant experiencein working with external partners (CMOs/CDMOs) and managing complex technology transfers.
Expertisein process analytical technologies (FT-IR NIR FBRM UV-vis etc.) chemometrics and modeling (statistical and first principles).
Experience with advanced process control strategies and continuous manufacturing.
Strong background in crystallization particle engineering and polymorph control.
Priorsuccess in building new technical platforms and organizational capabilities.
Experience with process safety evaluation risk assessments and pilot plant operations.
Experience navigating changing external and internal environment and leading others through change by creatingandinspiring and engaging workplace
Experience recommendinginfluencingand implementing organizational change and continuous innovation
Proven scientifictrack recordthrough presentations at scientific conferences and publication of peer-reviewed manuscripts.
Knowledge and Skills:
Leadership:Proven ability to lead mentor and inspire high-performing technical teams.
Strategic Vision:Ability to define and implement long-term technical and organizational strategies.
Technical Depth:Recognized subject matterexpertisein process engineering with broad knowledge across reaction engineering particle science and scale-up.
Communication:Excellent written and verbal communication; able to influence across functions and present effectively to senior leadership and external stakeholders.
Collaboration:Strong cross-functional teamwork; ability to build relationships internally and externally.
Problem-Solving:Strong analytical risk assessment and decision-making skills.
External Engagement:Active involvement in professional networks with a record of publications presentations or scientific leadership in the field.
TRAVEL REQUIREMENTS:
May requireapproximately5-10% travel.
This position is currently classified as hybrid in accordance with Takedas Hybrid and Remote Work policy.
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:
Cambridge MAU.S. Base Salary Range:
$212000.00 - $333190.00
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 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. U.S. based 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. U.S. based 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.
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Required Experience:
Exec
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
