About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Associate Director, Molecular Analytics, Cell Therapies Analytical Development where you will will join a dynamic team of scientists whose main mission is analytical method development to support cell therapy projects in all phases of clinical development. You bring in deep knowledge on molecular technology applicable to CMC and be responsible for product control strategies through life cycle management of cell therapy products. As part of the Oncology Cell Therapy and Therapeutic Area Unit (OTAU) team, you will report to the Head of Viral Vector and Cell Bank Analytics, Cell Therapy.
How you will contribute:
Our team is looking for an Associate Director to lead our Analytical Development efforts for Cell Therapy products. You will join a dynamic team of scientists whose main mission is analytical method development to support cell therapy projects in all phases of clinical development. You will have a strong background in molecular biology and method development, experience developing molecular assays in a regulated environment, familiarity with analytical method transfers to CROs, as well as strong team management and interpersonal skills.
You will bring in deep knowledge on molecular technology applicable to CMC and be responsible for product control strategies through life cycle management of cell therapy products.
Lead the development of molecular assays (e.g. PCR, cell-based assays with molecular readout, sequencing, NGS, etc) used for release and characterization of viral vectors, cell banks and drug products.
Lead a team that investigates and implements new technologies and QC friendly molecular platforms within Cell Therapy CMC strategies to enable and deliver IND and BLA filings.
You will be responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs across global Takeda sites.
You will mentor and develop staff at all levels in the organization. Ensure timely completion and delivery of analytical results and documentation (eLN, reports, SOPs, etc.) to support product development during clinical phases.
You will be responsible for establishing operating budgets and managing expenses within those budgets
PhD in life science or engineering (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics) and at least 7 years of relevant industry experience, or a Master's with at least 10 of relevant industry experience or Bachelor's degree in a life science and at least 12 years of relevant industry experience.
Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T or CAR NK products is a big plus.
Extensive experience in lead analytical activities to support IND, Phase I/II, pivotal and commercialization in the biotech and pharmaceutical industry
Experiences with genomic & molecular methods e.g. PCR (qPCR & ddPCR), NGS, bioassays for impurity assessment and characterization, critical material assessment and ID test development, comparability studies are required.
Proven track record and demonstrated deep understanding of pharmaceutical drug development, program development and cross-functional engagement
Self-motivated and comfortable working independently in a fast-paced environment.
Demonstrated ability to work in a matrixed environment and interact productively with associates, scientists, and management at various levels, both locally and internationally.
Experience working in a regulated environment.
Excellent written and verbal communication skills.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.