Head, Process Research

Boston, MA, United States

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Job Description

The Process Research (PR) group within Synthetic Molecule Process Development (SMPD) is a global team responsible for interfacing with Takeda's Discovery functions (e.g. medicinal chemistry, DMPK, Drug Safety) with the goal of route identification and phase appropriate route development to deliver GLP Tox and Ph 1 GMP Drug Substance (DS). The PR team is accountable for process knowledge transfer after Ph 1 to the downstream Process Chemistry (PC) team in SMPD.

The successful candidate for Head of Process Research will manage his/her staff with accountability for performance and results including: coordination with Research functions (medicinal chemistry, DMPK and Drug safety) to define strategies and deliverables, rapid design of scalable synthetic routes, phase-appropriate strategies for process optimization, oversight of cGMP manufacture, and transfer to downstream Process Chemistry (PC) team. As a leader within the global synthetic molecule process development department, the successful candidate will contribute his/her technical expertise across multiple sites and multiple teams, defining global best practices and maintaining and deepening our global expertise by benchmarking current industry trends in process chemistry and participation in industrial/academic consortia. He/she will also be expected to lead and drive both line function and cross-functional strategy and lead teams with accountability for performance and results.

ACCOUNTABILITIES:

Responsible for technical, budgetary, and development oversight of the global PR group

Assure technical deliverables for DS projects under team direction (route scouting, phase appropriate process development work, cGMP productions, tech transfer to PC)

Managing relationships with key stakeholders in Takeda's discovery functional lines such as Medicinal Chemistry, DMPK, and Drug Safety to insure optimized strategies and shared deliverables.

Develops and manages strategies for process research infrastructure, resources, projects, outsourcing, etc. in conjunction with local and global senior staff.

Serves as a technical resource to guide group members in strategic decision making and conducts analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.

Monitors and participates in establishing industry trends and recommends and implements new technologies and innovations to deliver upon process chemistry goals as appropriate.

Develops discipline/departmental plans/initiatives and drives strategy and implementation for process chemistry, creating linkages with strategies of other relevant functions.

Accountable for all aspects of department performance, personnel issues, and effective communication within group and with the company.

Provides technical/departmental leadership by fostering development of skill sets among staff and providing guidance on project leadership and cross-functional awareness.

Mentoring team members serving as Leads for early phase cross-functional CMC teams.

Drives cross-departmental, R&D-level and cross-divisional strategy and identifies topics for initiatives and leads global department, cross-department, R&D-level and cross-divisional initiatives with accountability for performance and results. Communicates efforts with senior management of other functions as appropriate.

EDUCATION, EXPERIENCE AND SKILLS:

Education and Experience:

Required:

Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 20+ years relevant industry experience

Master's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 18+ years relevant industry experience

PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years relevant industry experience

Knowledge and Skills:

Resource Management - Project management skills and familiarity with financial aspects related to projects including ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital)

Demonstrated ability to supervise team of employees, while fostering a positive/collaborative work environment.

Demonstrated ability to coach and mentor direct reports, identifying growth opportunities and supporting their professional development.

Analytical and Problem-Solving Skills - Able to troubleshoot the critical issues or problems and determine causes and possible solutions

Teamwork - Ability to work well on and effectively lead global cross-functional teams

Communication Skills - Ability to expresses oneself clearly and concisely within team; documents issues and/or concerns concisely and comprehensively; adjusts communication style appropriate for the audience; timely and effectively communicates with senior management and direct reports; technical writing skills to support authorship of internal/external & approve internal technical documents

Organization - Exercises good time management and prioritization skills to balance a number of project and departmental objectives.

Technical - Relevant expertise across a broad range of disciplines related to drug development

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

External Involvement - Involved in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Involvement in establishing and applying industry trends. Advises team members or directly interacts with external vendors for projects

LINE FUNCTION SPECIFIC QUALIFICATIONS:

Process Chemistry:

Significant relevant early phase pharmaceutical development experience

Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's.

Sound knowledge of current Good Manufacturing Practices (cGMP).

Previous experience with the use of contract facilities.

Understanding of a wide range of synthetic organic chemistry, including reaction mechanistic aspects and synthetic route design (retrosynthetic analysis), paired with excellent laboratory and productivity skills.

Proficiency in multi-step synthesis, purification, and characterization of complex organic molecules using the latest techniques.

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.

Empowering Our People to Shine

Learn more at takedajobs.com .

No Phone Calls or Recruiters Please.

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

U.S. Base Salary Range:

$205,100.00 - $322,300.00

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.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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