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Accountabilities:
Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department
Contributes significantly and independently to project work which may include multiple projects within functional area.
Plans and implements resolutions to technical problems/issues
Independently designs and executes experiments, and reports results
Recommends, justifies and implements technologies and innovations.
Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.
Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams
Conducts analysis of technical and conceptual risk and trends
Identifies process trends and defines/champions process strategy or use of novel technologies
Recognized as a technical expert and resource within function
Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences
Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff.
Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges
Coordinates and leads technology transfer to internal or external manufacturing sites
Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.
Represents Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.
Education and Experience:
A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees in chemical engineering required.
Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred
Experience in building reaction kinetic models as well as process models preferred.
Experience in building laboratory and pilot plant equipment a plus
Experience in crystallization process development and scale-up with an emphasis on form, purity, and particle size control a plus
Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus
Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required
Experience in building chemometric models preferred
Experience in developing continuous processes a plus
Sound knowledge of current Good Manufacturing Practices (cGMP) preferred
Experience working in a pilot plant a plus
Previous experience with the use of contract facilities and managing technical transfers a plus
Experience in working in a multi-disciplinary team environment
Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts
Knowledge and Skills:
Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
Teamwork -- Ability to work well on global cross-functional teams.
Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives
Technical - Subject matter expertise in a specific scientific area or areas.
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
Resource Management -Project management skills; ability to manage one’s time within individual, departmental
External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
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