Head of Process Chemistry, Synthetic Molecule Process Development (PC SMPD) TSHO

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Job Description

The Process Chemistry (PC) group within Synthetic Molecule Process Development (SMPD) is responsible for the development and execution of robust and cost-effective processes for the manufacture of new synthetic molecule Drug Substance (DS), along with methods for achieving and controlling high standards of purity and quality, from hand-off from the Process Research team at Ph1 through PPQ and transfer to Commercial.

The successful candidate for Head Process Chemistry TSHO group will manage his/her staff with accountability for performance and results including: the development and characterization of chemical processes with a focus on robustness, sustainability and COGS, technical transfer to manufacturing sites, oversight of cGMP manufacture, and representation on CMC teams.  They will develop their staff to deepen their expertise in disruptive route scouting utilizing innovative synthetic approaches, subsequent process development and process characterization and PPQ support. 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 PC group at the TSHO site

• Assure technical deliverables for DS projects under team direction (process development work captured in technical reports, tech transfer and cGMP productions, process characterization consistent with QbD principals, and process validation as appropriate)

• Develops and manages strategies for process chemistry 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.

• 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

• Sound knowledge of current Good Manufacturing Practices (cGMP)

• Significant relevant pharmaceutical development experience

• Significant relevant experience with industrial/academic consortia establishing industry trends/best practices

• Significant technical and strategic leadership experience with direct accountability for managing a team of direct reports

• Experience leading in a multi-disciplinary environment with accountability for informing departmental or functional strategy.

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:

• PhD-level research in organic chemistry or related field; or substantial industrial organic chemistry lab-based research experience

• Outsourcing experience

• Advanced proficiency with typical analytical tools (e.g. NMR, UV, IR, HPLC)

• Proficiency with utilizing typical literature searching techniques to solve organic chemistry problems  

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

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