Overview

The Director Technical Product Leader will support the development of new Tumor Infiltrating Lymphocytes (TIL) products. This role is a matrix role and will be based in Philadelphia, Pennsylvania. To be successful in the role, you must have prior experience as a CMC professional responsible for leading a cross-functional CMC team in the development of next-gen TIL cell therapy programs (pre-IND to clinical/registrational), with strong strategic focus, scientific and technical expertise, and regulatory and quality awareness. The Technical Product Leader should know and understand the regulatory guiding principles of cell and gene therapy product development and commercialization, have experience with clinical and commercial regulatory submissions, and be familiar with compliance of GMP operations in support of advanced therapy operations.

Essential Functions and Responsibilities

• The Technical Product Leader will lead the cross-functional CMC team, represent CMC, and deliver CMC objectives to the Product Development Team (PDT).
• They will formulate and implement a scientifically sound and business-driven project strategy, including contingency planning, risk assessment, and risk management.
• They will manage external partners and vendors, including creating and managing timelines and budgets.
• They will proactively communicate overall project strategy, status, key issues, and any other critical topics promptly to CMC team members, the PDT, and appropriate management stakeholders.
• They will understand and proactively manage the interactions of the project with current commercial and clinical activities between their department (P&AD) and other departments (Manufacturing Sciences & Technology, Analytical Sciences & Technology, Manufacturing Operations, Quality Control, Quality Assurance, Regulatory CMC, Supply Chain, Strategic Manufacturing).
• They will foster strong team spirit and promote and facilitate knowledge exchange within and between teams.
• They will support the overall product technical development plan based on Iovance Biotherapeutics annual goals, critical projects, support for Product Development Team objectives, and regulatory commitments.
• They will act as a reviewer of CMC sections of Regulatory submissions and respond to global agencies' queries for various product submissions as required. They may author CMC sections or responses to queries as needed.
• They represent CMC functions in interactions with global regulatory agencies during development and initial licensure.
• They assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical manufacturing to process validation.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

Required Education, Knowledge, Skills, and Abilities

• Must have extensive knowledge of cGMP operations, Quality, as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA, etc.) 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.
• Must be able to interpret problems, make risk-based decisions, and effectively communicate in a productive manner to management and teams.
• Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
• Must have strong troubleshooting skills and be able to critically review information, interpret results, and generate technical conclusions consistent with Quality and regulatory requirements.
• 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

Required Education, Knowledge, Skills, and Abilities

• 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.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position, standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

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 careers@iovance.com.

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