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 Scientific Manager, 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 a Senior Scientific Manager in the Pharmaceutical Sciences Cell Therapies team, you will be empowered to build our Cell Therapy footprint, and execute our strategy.
- The Senior Manager of Process Development and Manufacturing will be executing strategic plans for the build out of a world-class cell therapy process development and early clinical manufacturing group. The position will coordinate with other departments and manage staff performing daily operations in support of company goals and driving objectives to completion.
- In the laboratory setting, the position will manage lab daily operations, play an active role in implementing 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 lab operations are efficient and that individual team members are operating at a high level of performance. The position will also mentor staff members, foster a spirt of team work, and help the staff grow technically and professionally.
- 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 manage development and manufacturing staff and projects and work closely with the analytical and quality groups to ensure that that clinical products are manufactured with a high degree of quality and the manufacturing facility maintains compliance with cGMP requirements.
- The key objectives are:
- Manage laboratory, manufacturing infrastructure, PD, Manufacturing and Tech Transfer Projects
- Team buildout support activities associated with hiring and training of process development and manufacturing staff
- Facility buildup be actively involved in the specification, procurement, and installation of equipment
- Lab operations lead the set-up of laboratory systems and tools for managing activities, planning experiments, managing and analyzing data, communicating information, and documenting results; ensure that laboratory operations meet EH&S requirements
- Manufacturing operations lead the establishment and on-going maintenance of cGMP systems, facilities, and equipment for the manufacture of early phase clinical trials
- Leads team in the successful execution of specific cell therapy development and manufacturing projects
- By being actively engaged in daily operations and experiment/process design, manage one or more groups of development and manufacturing staff in the execution of cell therapy projects
- Provide technical oversight to lab activities and ensure that experimental design is sound and appropriate to achieve objectives, that meaningful conclusions can be reached, and that information is accurately captured and archived
- Lead tech transfer activities between development and manufacturing, and with outside collaborators, CMOs, and testing laboratories
- Champion the evaluation of new and innovative manufacturing processes and tools and their successful implementation
- Participate on multi-disciplinary project team and report-out/manage progress towards project deliverables; proactively identify bottlenecks and champion solutions to overcome obstacles.
- Participate in generating written CMC content necessary for IND and other regulatory submissions; ensure that CMC content is well integrated, consistent, and technically sound
- 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.
- Collaborate with outside biotech companies, suppliers, academic groups, and C(D)MO partners:
- Work collaboratively to advance technology development and novel manufacturing solutions
- Promote the reputation of the organization as a leader in the cell therapy field through participation in technical conferences
- Accountable for your team in Cell Therapy process development and manufacturing team, including project execution, project management, hiring, training, staff assignment, coaching, mentoring and performance management.
- Accountable for specific project elements as assigned in process development laboratory and early stage clinical manufacturing or management of a PD, Manufacturing and Tech Transfer Projects
- Responsible for the successful transfer of early or late phase process and analytics from biotech and academic partners or internal programs to Pharm.Sci. or from Pharm.Sci to C(D)MO partners
- Accountable for Cell Therapy CMC content to enable and deliver IND and BLA filings.
- Responsible for managing expenses within budget
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree (MS or PhD) 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 5 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 on product development teams
- Proven track record and demonstrated success in process development and/or clinical manufacturing.
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
- Must be willing to occasionally work weekends or be on call if required by project demands and manufacturing facility needs
- Occasional 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.