Head, Process Research
1 month ago
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.
**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
**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
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