Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Process Development and Manufacturing in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Cell Therapies team, you will be empowered to be a leader in the Pharm Sci organization and develop and execute far-reaching strategies, and a typical day will include:
POSITION OBJECTIVES:The Senior Director of Process Development and Manufacturing will bring vision and leadership to the Pharm Sci team and deliver on building out a world-class cell therapy process development and early clinical manufacturing group. The position will work with the Head of Cell Therapies Pharmaceutical Sciences and other directors 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 setting up strategy and translate that strategy into action.
In the laboratory setting, the position will lead a group of PD scientists in the development of cutting edge cell therapy products and innovative manufacturing solutions. The position will provide leadership in ensuring that development activities are well defined, coordinated, and consistent with the overall corporate strategy.
The position will also be responsible for early clinical manufacturing activities and championing a customer-focused and collaborative culture with a high regard to the objective of delivering life-saving therapies to patients in need. The position will work close with the quality, analytical, and regulatory groups to ensure the clincal products are manufactured with a high degree of quality and the manufacturing facility maintains compliance with cGMP requirements.
The key objectives are:
- Buildout the Process Development and Manufacturing capability:
- Team buildout identify talent, recruit and effectively manage a highly skilled team of scientists, managers and process engineers in cellular therapy process and analytical development
- Facility buildup design the footprint of development labs, manufacturing space
- Set strategy and establish industry-leading CMC capabilities for cell therapies, and drive the buildup of an integrated team spanning the CMC, discovery/research, and clinical/translational functions.
- Establish and foster a culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, inclusion and trust.
- Lead the CMC team in successful execution of cell therapy programs
- Establish and lead the Cell therapy CMC team focused on process development and product manufacturing for early clinical stage cell therapy programs.
- Establish and execute CMC strategy for acceleration of cell therapy programs from early to pivotal/commercial stage, including scale up/scale out solutions, automation, and manufacturing cost reduction.
- Drive the team s performance to develop robust cell therapy processes and integrated analytical characterization.
- Design and develop processes in collaboration with academic and biotech partners; partner with them in the successful execution of manufacturing projects .
- Work with the clinical team to integrate manufacturing operations with the receipt of patient donor cells and delivery of therapeutic product
- Drive the global strategy for continuous and phase-appropriate process/analytical/ manufacturing optimization towards standardized platforms and streamlined world-wide tech transfer.
- Manage CMOs and external suppliers:
- Manage the supply chain of critical materials (e.g. viral vector, starting donor tissues, critical reagents and consumables) to ensure timely and cost effective delivery
- Manage and partner with cell therapy CMOs and testing laboratories to plan and execute successful tech transfers and build collaborative relationships
- Engage with outside organizations and drive collaboration with biotechs, academic and C(D)MO partners.
- Identify and form collaborative relationships to advance technology developmement and novel manufacturing solutions
- Seek out and create opportunities for team members to participate in conferences and other learning opportunities
- Promote the reputation of the organization as a leader in the cell therapy field through participation in technical conferences
- Accountable for the leadership of the Cell Therapy process development and manufacturing team, including defining its vision, strategy, execution, hiring, training, staff assignment, coaching, mentoring and performance management.
- Accountable for process development, integrated analytics and early stage clinical manufacturing, including the buildup of the capabilities and the operations
- Responsible for the successful transfer of early phase process and analytics from biotech and academic partners or internal programs.
- Accountable for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings.
- Responsbile for establishing operating budgets and managing expenses within those budgets
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree (PhD highly desirable) in relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry), and significant prior experience in the manufacture of cell and gene therapies.
- Minimum 10 years of relevant experience in leadership and people management with successful performance track record. Experience in technical development of biologics and other advanced modalities in early and late develoment setting is highly desirable.
- Excellence and successful track record in managing interfaces with other functions and integrated teams.
- Relevant experience in cell and gene therapies CMC teams including experience with clinical trial, financial reporting, and/or project management systems and processes.
- Proven track record and demonstrated deep understanding of pharmaceutical drug development, program and project development.
Knowledge and Skills:
- Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
- Ability to lead successfully within extended, global multinational project teams and handle multiple challenges under pressure.
- Demonstrated ability for innovative and big picture thinking.
- Requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence.
- Excellent communications and presentation skills written and verbal; create and deliver presentations with appropriate messaging and focused recommendations
- Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously
- Negotiation and strong persuasive abilities, diplomacy and positive influencing abilities
- Fluent in English
- Approximately 15% travel is required.
- Domestic and international flights with overnight stays required
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
No Phone Calls or Recruiters Please.