Biotherapeutics Pivotal Development Support Lead

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Job Description

This role sits in Biotherapeutics Process Development (BPD) and is responsible for guiding and leading late-stage development activities for Biologics Drug Substance Process Development. This includes QbD workflow execution, process characterization strategy, PPQ strategy, and support of regulatory filings. This is a global role and therefore responsible for guiding BPD teams on late-stage development strategy across all BPD geographies.

Accountabilities:                                                                                                         

• Guide BPD teams on late-stage process development strategy and activities including QbD, process characterization, and PPQ strategy.  

• Drive execution of QbD workflow for biologics drug substance development.

• Conduct data analysis and modeling of process characterization results.

• Accountable for ensuring BPD teams complete all late-stage activities on time and right first time.  

• Authoring of late-stage development documents to support BPD teams.

• Support authoring of relevant sections for IND and BLA submissions.

• Communicates and coordinates implementation of procedural improvement to senior management, across therapeutic and scientific areas.

• Conducts analysis of technical and conceptual risk; identifies and champions operational processes and strategies.

• Identifies topics for initiatives and leads local/global department initiatives. 

Education & Competencies:

• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 11+ years relevant industry experience.

• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 9+ years relevant industry experience.

• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 3+ years relevant industry experience.

• Experience in CMC pharmaceutical development for active pharmaceutical ingredients.

• Profound knowledge of Quality by Design (QbD) approach and statistics.

• Sound knowledge of current Good Manufacturing Practices (cGMP).

• Knowledge on regulatory agency requirements for biologics DS development.

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

Knowledge and Skills:

• Experience in biologics late-stage 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 global cross-functional teams; Proven ability to foster a highly efficient team environment.

• 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 and approve internal technical documents

• 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.

• Project management skills and familiarity with financial aspects related to projects.

• External Involvement – Involved in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Communicates or applies industry trends. Advises team members or directly interacts with external vendors for projects.

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