Senior Director, CMC Product Development Team Leader

Iovance Biotherapeutics is seeking a Senior Director in the CMC organization to support its Tumor Infiltrating Lymphocytes (TIL) products.  This position is a critical leadership role within Iovance' s Commercial and Clinical programs, focusing on coordinating and driving cross-functional activities within the Chemistry, Manufacturing, and Controls (CMC) domain. As the CMC Lead, this individual will need a blend of strategic leadership, program management expertise, and in-depth knowledge of CMC processes in the pharmaceutical and biopharmaceutical industry.

The candidate should possess strong leadership skills, be resourceful, and be able to navigate complex cross-functional environments effectively. They will need to balance high-level strategic oversight with attention to operational details to ensure smooth execution of all CMC-related activities.

Key responsibilities include:

Portfolio Management & Strategy: Overseeing and guiding the implementation of integrated CMC portfolio strategies for commercial and clinical products, and associated goals, budgets, and timelines.

Cross-Functional Leadership:

Leading CMC teams and coordinating activities across multiple departments including Process and Analytical Development, Manufacturing Sciences and Technology, Analytical Sciences and Technology, Manufacturing, Quality Control, Quality Assurance, Regulatory CMC, and Supply Chain.

Program Execution & Risk Management:

Managing the day-to-day execution of the program strategy, ensuring all CMC timelines and milestones are met. This will involve identifying risks and mitigating them in coordination with other departments.

Stakeholder Interaction:

Proactively managing the interactions between clinical, commercial, and CMC activities, fostering strong relationships with key stakeholders.

Collaboration:

Working closely with the key stakeholders to determine project timelines, manage resources, and define the comprehensive portfolio strategy

Experience and ability to develop and deliver presentation to senior leadership

Strong understanding of project planning principles and ability to lead effectively

Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Perform miscellaneous duties as assigned.

 

Travel

• Travel - < 10-20% for meeting, workshop, presentations at Iovance facilities 

 

Required Education, Skills, and Knowledge

• Bachelor’s degree in scientific discipline or related field required.
• 13 years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry.
• Demonstrated ability to manage multiple projects, interfacing with multi-disciplined teams.
• Basic understanding of scientific and quality principles as they apply to oncology drug products.
• Ability to apply scientific principles, assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
• Proven experience working and leading in a matrix environment.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities and ability to manage ambiguity.
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving and critical thinking skills.
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve them
• Preferred Education, Skills, and Knowledge
• Familiarity/experience with end-to-end CMC drug development and/or cell therapy.
• Previous experience supporting ramp up in a quality control environment.  

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an 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 perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.  
• 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 works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

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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 to change the duties of the position 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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