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Head of Biotherapeutics Process Development - Senior Director at Research & Development

Head of Biotherapeutics Process Development - Senior Director

Research & Development Lexington, MA Full-Time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas [ Link removed ] - Click here to apply to Head of Biotherapeutics Process Development - Senior Director and [ Link removed ] - Click here to apply to Head of Biotherapeutics Process Development - Senior Director. I further attest that all information I submit in my employment application is true to the best of my knowledge.



Job Description



About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as the Head of Biotherapeutics Process Development-United States (PDUS). You will bring vision, strategic direction, and leadership to the Pharmaceutical Sciences organization and deliver on building a world-class biotherapeutics process development function. The Biotherapeutics PDUS group will perform developability assessments, clone selection, process development (Upstream and downstream), and clinical manufacturing of drug substance for biologic therapeutic candidates using mammalian cell or microbial production system. In addition, the position will manage teams for process development and clinical manufacturing of viral vectors for cell therapy applications. The in-process analytics group that supports this function will also report into this organization.



How you will contribute:

The Head of Biotherapeutics PDUS will work closely with the Head of Biotherapeutics Process Development (BPD) for Pharmaceutical Sciences, and other Sr. leaders of BPD to lead and direct the strategy at the interface between portfolio management, project management, and operations. The position will help drive the team's execution and proactively contribute to development strategy and translation of that strategy into action.

The position will provide leadership ensuring that development activities are well defined, coordinated, and consistent with the overall corporate strategy. The position will also drive the development of group leaders and talent and champion an inclusive and engaging culture to drive overall department performance in support of the development of cutting-edge processes and innovative manufacturing solutions.

The position will partner with the leaders of Analytical development, Drug product development, Manufacturing, Quality and Regulatory functions to ensure the clinical products are manufactured with a high degree of quality and drive the global strategy for continuous and phase-appropriate process optimization in collaboration with customers.

Key objectives are:

Strategy for the Process Development capability:

  • Foster a customer-focused culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, inclusion and trust.

  • Identify talent, recruit and effectively manage a highly skilled team of scientists, managers and process engineers in upstream process development

Engage with outside organizations and drive collaboration with academic and industry partners.

  • Support collaborative relationships to advance technology development and novel manufacturing solutions

  • Promote the reputation of the organization as a leader in the bioprocess development field through publication and contributions to larger industry consortia

As assigned lead Global CMC teams in successful execution of early phase CMC development internally or in collaboration with partners

  • Establish and lead the CMC team focused on process development and product manufacturing for early clinical stage programs.

  • Design and develop processes in collaboration with academic and biotech partners; partner with them in the successful project execution

ACCOUNTABILITIES:

  • Direct and indirect supervisory responsibilities in one or more technical areas for development of high-quality biologic therapeutics

  • Drive team to obtain scientific data; data compilation and review; preparation and review of technical reports, regulatory filings, and other documentation; project/CMC team representation/leadership; technical interactions with internal partners and contract laboratories.

  • Contribute to setting the strategy and direction for the overall global function and frequently represents the function within CMC/Pharm Sci and across the global organization.

  • In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good/Laboratory/Manufacturing Practice (cGMP, cGLP) regulations.

  • Manage functional area budget and human resources to be within required limits.

  • Collaborate with other functions in PharmSci to encourage strategic alignment and successful achievement of shared goals.

  • Seamlessly interface with stakeholders, including research development and commercial

  • Be well versed in all stages of pharmaceutical development and understands the global regulatory trends for CMC activities, to ensure robust and high-quality regulatory filings in all countries active.

  • Lead global CMC key initiatives and represent PharmSci to other cross functional stakeholder key initiatives

  • Analyze and synthesize concepts from diverse information and articulate

  • Look for external benchmarks that help to aid superior performance of products, processes and people

  • Maintain an active understanding of the future trends of medicine to build an organization adaptable for the future.

  • Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment

  • Build future leadership while mentoring direct reports and junior employees



Minimum Requirements/Qualifications:

  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years relevant industry experience

  • 9+ years of direct industry experience in relevant development and manufacturing functional area of expertise.

  • Demonstrated people and program management skills, critical and out-of-the-box thinking ability, situational leadership skills

  • Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.

  • Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization

  • Experience in writing regulatory documents

  • Understands the structure, functions, and methods of the global organization and overall R&D operations.

  • Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe.

  • Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions

  • Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.

  • Demonstrated ability to effectively lead and motivate a team of direct reports, build on strengths, and address areas for improvement.

  • Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals



What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Flexible Work Paths

  • Tuition reimbursement



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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.



Locations

Lexington, MA

Boston, MA



Worker Type

Employee



Worker Sub-Type

Regular

Time Type

Full time

Recommended Skills

  • Analytical
  • Assessments
  • Benchmarking
  • Biology
  • Bioprocess
  • Biotechnology
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