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, Process Development and Manufacturing, 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 Process Development and Manufacturing will play a key leadership role within the Pharmaceutical Sciences Department in executing strategic plans for the build out of a world-class cell therapy process development and early clinical manufacturing group. The position will align with other department directors and staff to define to prioritize specific objectives in support of the company goals and drive those objectives to completion.
- In the laboratory setting, the position will help manage high level lab operations, play an active role in identifying novel manufacturing solutions, and champion the successful completion of development projects by helping teams overcome technical and resource obstacles. The position will also ensure that development activities are aligned with the needs of manufacturing, analytical, quality, regulatory, and clinical teams. The position will also mentor staff members, foster a spirit of team work, and help the staff grow technically and professionally.
- The position will oversee 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 ensure the clinical products are manufactured with a high degree of quality and the manufacturing facility maintains compliance with cGMP requirements.
The key objectives are:
- Build out laboratory and manufacturing infrastructure
- Team buildout Lead activities associated with hiring and training of process development and manufacturing staff
- Facility buildup provide input into the design of development labs and manufacturing space, and installation of equipment
- Lab operations support the set-up of laboratory systems and tools for managing activities, planning experiments, managing and analyzing data, communicating information, and documenting results
- Manufacturing operations support the establishment of cGMP systems, facilities, and equipment for the manufacture of early phase clinical trials
- Lead CMC teams in the successful execution of specific cell therapy development and manufacturing projects
- Coordinate with product development teams to define CMC project plans that includes project deliverables, timelines, and budgets
- Lead multi-disciplinary project team and manage progress towards project deliverables; identify bottlenecks and champion solutions to overcome obstacles.
- Lead in generating written CMC content necessary for IND and other regulatory submissions; ensure that CMC content is well integrated, consistent, and technically sound; ensure that supporting development and manufacturing information is reliable and maintained
- 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
- Support the 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 cell therapy CMOs and testing laboratories to plan and execute successful tech transfers and build collaborative relationships
- 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 the Cell Therapy process development and manufacturing team, including project execution, hiring, training, staff assignment, coaching, mentoring and performance management.
- Accountable for process development 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 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, Bioprocess Engineering, Immunology, Molecular Biology, Biochemistry), and significant prior experience in the manufacture of cell and gene therapies.
- 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.