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Job Description

Objective:

Under the direction of the Director or Sr. Director, ODPD, the Assoc. Director is responsible for supporting the Takeda pipeline programs with expertise in drug product formulation development, process development, drug product manufacturing, regulatory support, validation thru commercialization of oral drug products for global markets. Expertise in drug product manufacturing process optimization, scale up and QbD are required. The Assoc. Director actively manages and oversees Takeda employees and contractors to achieve Takeda pipeline project and ODPD function goals. The individual sets and defines drug product goals upon project inception and implements actions required in achieving program goals. The individual is expected to represent the Department on PSTs/GPTs, and other cross functional forums as deemed necessary.

Job Description:

+ DevelopsCMCstrategy for the oral drug products and provide budget estimatesforR&D pipelineprojects.

+ Managesthedevelopmentofdrugproductformulation/manufacturing processes at both internal laboratories and at external CDMOs

+ ResponsibleforprovidingguidancetoTakedacontractors as needed

+ Writes/reviews/approvesprotocols and reports fordrugproducts

+ Managesanyreportingstaff(Takeda employeesand/orcontractors).

+ Preparesorsupervisespreparationofhigh-quality DP-CMCsectionsfor Global regulatory filings to meet accelerated submission timelines and manages RTQs in a timely manner

+ Activelyparticipatesinpreparationsforinternalauditsandregulatory inspections and agency interactions.

+ IsanactivememberofPharm Sci teams.

+ Contributesto ODPD/DPDD/PharmSci innovation/improvementinitiatives.

+ Performs CMC duediligenceevaluationsofpotentialneworin-licensed products on behalf of Pharmaceutical Sciences.

+ Uses In-Silico, DOEandQbDprinciplesindevelopingDrug Product manufacturing processes.

+ InteractswithcounterpartsinGMSGQtoensure robust processes are effectively transferred to both internal and external sites.

+ PreparesandmaintainsPharmSci/DPDDSOPsasassigned.

Education & Experience** **Requirements

+ Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, or closely related field with 15+ years of Pharmaceutical Industry experience is required.

+ M.S. Degree in Pharmaceutical Sciences, Chemical Engineering, or closely related field with 13+ years of Pharmaceutical Industry experience is required.

+ Ph.D. Degree in Pharmaceutical Sciences, Chemical Engineering, or closely related field with 10+ years of Pharmaceutical Industry experience is required

+ Supervisory experience is required

+ Significant experience in oral drug product formulation development, process development and manufacturing is required.

Key Skills and** **Competencies

+ Proven working knowledge of current GMP regulations.

+ Detailed knowledge of Global regulatory requirements for drug products.

+ Knowledge of current pharmaceutics technology, including formulation and manufacture of oral solid, liquid and semi-solid dosage forms. Sterile product experience is desirable

+ Experience in robust process development, scale-up, manufacturing and validation, including DOE and QbD.

+ Knowledge of clinical supply requirements and regulations.

+ Must have a working knowledge of various analytical methods used during the development of pharmaceutical products, including, but not limited to, HPLC, IR, UV, NMR, Mass Spec., dissolution and tablet hardness, etc.

+ Must be able to apply product development expertise to CMC sections of the regulatory filings.

+ Experience of both Early and Late-stage development including product stability and product packaging and labeling requirements.

+ Ability to present complex issues well in oral and written form.

+ Ability to work independently, take initiative, and complete tasks to deadlines.

+ Excellent interpersonal, communication, analytical, managerial, and organizational skills.

+ Ability to effectively present information to senior management, external CDMOs and employees at all levels of the organization.

+ Excellent management skills for coaching and mentoring team members and reporting staff (employees and/or contractors).

+ Strong team player. Excellent leadership skills. Basic knowledge of project leadership tools including MS Project

Complexity and Problem** **Solving:

+ Objective setting of any reporting staff (employees and/or contractors).

+ Budget management and sign off at Assoc.Director authorization level, CMC -DP strategy development, implementation, and vendor selection

+ Author, review, approve and manage product development protocols and reports

+ Authoring, review, approval and management of high-quality global CMC regulatory submissions and timely responses to agency RTQs

+ Accountable to the Director or Sr. Director, ODPD-US

+ Internal contacts: PSPL, AD, SMPD, Pharm Sci QA, CPA, CMC-GRA, GMSGQ

+ External contacts: Regulatory agencies. Vendors: DP Development and contract manufacturing organizations

PHYSICAL DEMANDS:

+ Some hands-on laboratory work may be required

TRAVEL REQUIREMENTS:

+ Requires occasional travel to various meetings or vendor sites to oversee mfg. activities. Some international travel may be required.

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

$153,600.00 - $241,340.00

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 job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

It 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.