Head, Biotherapeutics Pivotal Development Support

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Job Description

Objective / Purpose:

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

Accountabilities:

• Guide BPD teams globally on late-stage process development strategy and activities.

• Serve as an advisor to BPDLT on all late stage development projects.

• Accountable for standardizing late-stage development strategy and implementation across all BPD geographies.

• Manages a team of fellows/experts that is accountable for ensuring all late stage activities are completed in accordance with regulatory agency expectations.

• The team is also accountable for ensuring BPD teams completes all late stage activities on time and right first time.  

• Advice BPD teams on process characterization, QbD, PPQ, and authoring BLA sections.

• Responsible for preparing BPD teams for CSRB presentations/discussion.

• Manages aspects of department performance, personnel issues, and effective communication within group and with the company as directed by senior staff.

• 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. 

• Ensures effective project management of initiatives and projects within own area of responsibility and direct reports, linking scientific efforts to company, program and functional goals.

• Contributes to cross-department strategy and initiatives and serves as technical resource to guide group members in strategic and technical decision making.

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

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

Education & Competencies (Technical and Behavioral):

• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 20+ years relevant industry experience.

• Masters 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; 12+ years relevant industry 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).

• In depth knowledge on regulatory agency requirements for biologics DS development.

• Significant relevant pharmaceutical development experience.

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

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

• Experience leading functional regulatory 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

• Organization - Exercises good time management and prioritization skills to balance several 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.

• 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)

• 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.

• Leadership Skills - Demonstrated ability to manage up and down the organization; Ability to use appropriate management strategies to provide direction for the work of team members and support individual development

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.

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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.

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EEO Statement

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