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 an Associate 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 an Associate Director in the Pharmaceutical Sciences Cell Therapies team, you will be empowered to build our Cell Therapy footprint, and establish and execute our strategy.
- The Associate Director of Analytical Development will play a key leadership role within the Pharmaceutical Sciences Department in strategic plans for the build out of a world-class cell therapy analytical development and product characterization group. The position will lead the priorities of specific objectives with other department directors in support of the company goals and align all objectives to completion.
- The position will lead the subject matter experts in the characterization of CAR T-cells, other genetically modified immune cells, stem cells, and other advanced cell therapy products. The position will manage the high level analytical lab laboratory operations and 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 input on the commercialization strategy, especially with applying analytical methods during process development, scale-up, and comparability studies.
- The position will also partner with Manufacturing and Quality groups to oversee the analytical methods are used, inclinging. method transfer, troubleshooting, interpretation of results, and providing technical input of method qualification and validation.
- The position will oversee the support of pre-clinical activities in the development of analytical methods. This position will 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 outcomes and correlating therapeutic product critical quality attributes.
The key objectives are:
- Buildout the Analytical Development capability:
- Team leadership lead hiring and training/cross-training of analytical staff
- Laboratory buildup provide input into the design of analytical and QC labs, instrument selection, method development, and method qualification
- Lab operations oversee the the set-up of laboratory systems and tools for managing activities, planning experiments, managing and analyzing data, communicating information, and documenting results
- Work with the CMC team in successful execution of cell therapy programs
- Working closely with lab staff and, lead the analytical efforts focused on product characterization and testing for early specific cell therapy programs. Ensure that methods are fit for purpose, interpreted correctly, and reported clearly.
- Execute strategy for the development and qualification of analytical methods used to characterize and test complex products with consideration to automation, high-throughput methods, cost effectiveness, and rapid turn-around of results.
- Manage the integration 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 and external suppliers:
- 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 suitably qualified, performed to expectation, and results are returned in a timely manner
- Collaborate with outside biotech companies, suppliers, academic groups, and C(D)MO partners:
- Work collaboratively to advance technology development 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 elements of the Cell Therapy analytical development, including project 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 characterization.
- Responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs.
- Accountable for executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings.
- Responsible 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, Immunology, Molecular Biology, Biochemistry), and significant prior experience in analytical/QC testing and characterization of cell and gene therapy products
- Minimum 7 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 development 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 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
- Ability to work in a laboratory and cleanroom environment
- 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
Learn more at takedajobs.com
No Phone Calls or Recruiters Please.