|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 Director, Analytical Development, Pharmaceutical Sciences Cell Therapies in our Cambridge office.|
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Cell Therapies team, you will be empowered to help lead the Cell Therapy Pharmaceutical Sciences team and help to define the vision of the Analytical Development group, and a typical day will include:
The Director of Analytical Development will bring vision and leadership to the Cell Therapy Pharmaceutical Sciences team and deliver on building out a world-class cell therapy analytical development and product characterization group. The position will work with the Head of Cell Therapies CMC 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.
The position will be a subject matter expert in the characterization of CAR T-cells, other genetically modified immune cells, stem cells, and other advanced cell therapy products. The position will manage a group of development scientists to ensure that laboratory activities are well coordinated, analytical methods are qualified and fit for purpose, and information is effectively communicated and documented. The position will also provide expert input on the commercialization strategy, especially with applying analytical methods during process development, scale-up, and comparability studies.
The position will also partner with internal and external Manufaturing and Quality teams to ensure that appropriate analytical methods are developed and qualified and put into use for routine QC testing and characterization of therapeutic products, starting materials, and in-process samples. In particular, this position will champion and promote a mindset of uncompromised product quality and high standards in the manufacture of products intended for human use.
The position will also work with research to support pre-clinical activities and also provide expert technical support to the regulatory and clinical groups for regulatory submissions and planning and execution of human clinical trials. This position will interact with external collaborators and internal teams examining clinical samples and outocomes and correlating therapeutic product criticlal quality attributes.
The key objectives are:
- Buildout the Analytical Development capability:
- Team buildout identify talent, recruit and effectively manage a highly skilled team of scientists in cellular therapy and analytical development
- Laboratory buildup provide vision and guidance in establishing internal development capabilities
- Set strategy and establish industry-leading capabilities for cell therapy characterization and product testing
- Establish and foster a culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, inclusion and trust.
- Work with the CMC team in successful execution of cell therapy programs
- Lead the analytical efforts focused on product characterization and testing for early clinical stage cell therapy programs. This includes championing efforts at defining critical product quality attributes, product stability, and acceptance critiera.
- Establish and execute strategy for the development and qualification of novel analytical methods used to characterize and test complex products with consideration to automation, high-throughput methods, cost effectiveness, and rapid turn-around of results.
- Drive the the intergration of analytical methods into routine use in development and manufacturing to permit robust cell therapy processes with rapid feedback on product quality and critical process parameters
- Design and develop analytical methods in collaboration with academic and biotech partners; partner with them in the successful execution of research and manufacturing projects .
- Drive the global strategy for continuous and phase-appropriate process/analytical/ manufacturing optimization towards standardized platforms and streamlined world-wide tech transfer.
- Manage CMOs, external laboratories, and suppliers of critical reagents:
- Provide expert technical input and manage analytical testing issues associated with suppliers of critical materials (e.g. viral vector, starting donor tissues, critical analytical reagents)
- Manage analytical and product testing issues with cell therapy CMOs to plan and execute successful tech transfers, comparability studies, and build collaborative relationships
- Manage outside testing laboratories to ensure that methods are suitabliy qualified, performed to expectation, and results are returned in a timely manner
- 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 analytical methods and improvements
- 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 analytical development team, including defining its vision, strategy, execution, hiring, training, staff assignment, coaching, mentoring and performance management.
- Accountable for analytical development capabilities buildup and integrating analytical methods into early stage clinical manufacturing, product release testing, and product charateriztion.
- Responsible for the successful transfer of early phase 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 estabishing operating budgets and managing expenses within those budgets
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Knowledge and Skills:
- Advanced degree (PhD highly desirable) in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry), and significant prior experience in analytical/QC testing and characterization of cell and gene therapy products
- 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.
- 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
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
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.