Project Manager, Quality Control [Contract to Hire]

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Project Manager, primarily working with the Quality Control team, who will drive and support internal and cross functional projects within the Iovance Quality Control Department. This role will take the lead in driving all Quality Control projects, ensuring their on-time completion, and proactively identifying and solving roadblocks prior to their cause in delay. The Project Manager, Quality Control, will also keep all timelines updated with accurate due dates and actions required, including cross-functional responsibilities. The candidate should have solid cross-functional experience across all aspects of Quality Control, including but not limited to onboarding of new products and assays, method transfers, instrumentation implementation, validations, and qualifications. This role requires an outgoing, driven, and resourceful project manager who will play a key role in ensuring all Quality Control timelines are met. This role will work with the Head of Quality Control to identify the quality control projects and expected timelines, and own the comprehensive project plans and timelines.

Essential Functions and Responsibilities

• Plan, Manage and track and report on projects.
• In collaboration with cross-functional teams, create, establish, and maintain comprehensive project plans and timelines.
• Drive effort to create project management processes, best practices, tools and dashboards for cross - functional projects.
• Understanding and adherence to internal governance processes.
• Identify critical path and at-risk activities, anticipate bottlenecks, and help clear barriers to progress against department or corporate goals.
• Builds productive internal / external working relationships with cross - functional teams.
• Strong understanding of project planning principles and ability to lead effectively.
• Solid presentation skills for project progress and status / dashboard reports with senior leadership.
• Identify and initiate process improvements as appropriate.
• Willingness to do what needs to be done in a dynamic environment and work with internal and external stakeholders to manage project deliverables.

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

• Perform miscellaneous duties as assigned.

Travel - < 10%

Required Education, Skills, and Knowledge

• Bachelor's degree in a relevant discipline (biological sciences or equivalent)
• 5+ years in the Pharmaceutical Industry with 2 + years direct project management experience.
• Demonstrated ability to manage multiple projects, interfacing with multi-disciplined teams.
• Strong expertise in using Smartsheet, MS Project, MS PowerPoint, MS Visio, SharePoint, timeline visualization software e.g, One Pager, Swimlane.
• 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.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities and ability to manage ambiguity.
• Fundamental knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality records, and training.
• Ability to effectively balance multiple priorities involving aggressive timelines at a high level of productivity
• 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

• PMP certification preferred.
• 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 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 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 position will work in both an office and a laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste.

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 [redacted].

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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