Director, Technical Product Leader

3 days ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Summary

We are seeking a highly skilled and experienced Director, Technical Product Leader to join our team at Iovance Biotherapeutics Inc. This is a critical role that will support 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.
  • Understand and proactively manage interactions between the project and current commercial and clinical activities between departments.
  • 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, 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.
  • Represent CMC functions in interactions with global regulatory agencies during development and initial licensure.
  • Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical manufacturing to process validation.
Requirements
  • Extensive knowledge of cGMP operations, Quality, and general industry requirements for advanced cell therapy programs.
  • 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.
  • Ability to interpret problems, make risk-based decisions, and effectively communicate in a productive manner to management and teams.
  • Ability to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
  • Demonstrated leadership through partnership in a matrixed organization is required.
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
  • 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.
Preferred Qualifications
  • PhD with 6-8 years' experience in relevant Biological Science, engineering, or similar scientific discipline.
  • 4-6 years of experience in a product development role is preferred.
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. Standard office equipment and keyboards are required.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position's responsibilities at any time.

Iovance 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. If you need assistance or accommodation to apply to one of our opportunities, please contact

By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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