Associate Director, CMC Analytical Development, Cell Therapy

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Job Description

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, CMC Analytical Development, Cell Therapy where 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 CMC analytics including method development, GxP method validation, familiarity with analytical method transfers to CROs, as well as strong team management and interpersonal skills.You will report to the Head, Cell Therapy Product Control and Analytics .

How you will contribute:

• You will bring in deep knowledge of CMC analytical release and characterization technologies including flow cytometry, potency indicating cell-based methods, and process residual quantification applicable to the cell and gene therapy pipeline.

• Lead the implementation of innovative and QC-friendly strategic release and stability indicating CMC readouts including ligand binding assays, potency, sequencing, NGS, etc for release and characterization of viral vectors, cell banks, and drug products to enable and deliver IND and BLA filings.

• You will be responsible for the development, technology transfer, and implementation of product control strategies through life cycle management of Cell Therapy products at collaborator sites such as CROs, biotech and academic partners, or internal functions across global Takeda sites.

• Lead investigations on quality events related to analytical aspects involving viral vector and other material manufacturing within the Cell Therapies pipeline.

• You will mentor and develop staff at all levels in the organization in ensuring the timely completion and delivery of analytical results anddocumentation (eLN, protocols, reports, SOPs, specifications, etc.) to support product development during clinical phases.

• You will be responsible for establishing operating budgets for their team and managing expenses within those budgets

Minimum Requirements/Qualifications:

• Ph.D. in life science or engineering (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, or 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 life science and at least 12 years of relevant industry experience.

• Extensive experience in leading product teams responsible for CMC analytical activities to support IND, Phase I/II, pivotal and commercialization in the biotech and pharmaceutical industry is required

• Experience with potency and other cell-based methods for impurity assessment and characterization, critical material assessment and ID test development, and comparability studies in biologics is required

• Understanding various cell and gene therapies and gene editing technologies with previous experience in cell therapy products is a big plus

• Proven track record and demonstrated a deep understanding of pharmaceutical drug development, program development, and cross-functional engagement

• Work in a matrix team in a fast-paced environment and strong organizational, planning, and follow-up skills

Preferred Qualifications:

• 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 such as GxP/QC is highly preferred.

• 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 Ways of Working

• Tuition reimbursement

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.

Base Salary Range: $143,500.00 to $205,000.00, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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EEO Statement

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time