Director, Technical Product Leader

3 days ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Title: Director, Technical Product Leader

We are seeking a highly experienced Director, Technical Product Leader to join our team at Iovance Biotherapeutics Inc. This role will be responsible for leading the development of new Tumor Infiltrating Lymphocytes (TIL) products.

Key Responsibilities:
  • Lead cross-functional CMC teams and represent CMC functions in interactions with global regulatory agencies.
  • Formulate and implement scientifically sound and business-driven project strategies, including contingency planning, risk assessment, and risk management.
  • Manage external partners and vendors, including creating and managing timelines and budgets.
  • Proactively communicate overall project strategy, status, key issues, and any other critical topics to CMC team members, the Product Development Team, and management stakeholders.
  • Foster strong team spirit and promote knowledge exchange within and between teams.
  • Support the overall product technical development plan based on Iovance Biotherapeutics annual goals, critical projects, support for Product Development Team objectives, and regulatory commitments.
  • Act as a reviewer of CMC sections of Regulatory submissions and respond to global agencies' queries for various product submissions as required.
Requirements:
  • Master's degree in biological science, engineering, or similar scientific discipline with 12+ years of experience in CMC in a biotech, pharmaceutical, or biopharmaceutical organization.
  • Expertise in GMP compliance, global regulations, and a strong understanding of the pharmaceutical product development lifecycle are required, with specific emphasis on advanced/cellular therapy activities.
  • Strong project management skills and ability to communicate effectively across matrix functions.
  • Excellent verbal and written communication skills.
  • Ability to prioritize and balance work from multiple projects in parallel.
Work Environment:

This job involves working in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noises, lab equipment hazards, strong odors, and chemicals/biochemicals is possible.

Iovance Biotherapeutics Inc is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

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