Manager, Product Quality Operations and Stability

Overview

Iovance Biotherapeutics is seeking a Manager, Product Quality Operations and Stability, to join the Quality Assurance and Product Quality organization. The candidate will be instrumental in supporting the Amtagvi annual product quality review (APQR) to ensure that the process remains in a validated state of control in compliance with Health Authority expectations.  This may include content mapping and creating document templates, working with internal and external stakeholders to ensure delivery of content for the APQR, management of APQR-related documentation and deliverables, and tracking and managing drafting and assembly of the APQR to support overall delivery of the APQR for Amtagvi.

The candidate will have knowledge of and experience with quality systems and document management, specification management across clinical and commercial products including multi-national specification management strategies, tactical management of specification document reviews and approvals, change controls, specification review boards, etc., and have a solid technical understanding of stability-indicating methods with a strategic background related to stability programs for cell therapies and biologics including knowledge of guidance documents and regulatory requirements.

The candidate will serve as an influential change agent that is able to work collaboratively and cross-functionally with both internal and external stakeholders and management to support cross-program and cross-site alignment, establishing phase-appropriate stability and shelf-life strategies for clinical and commercial programs, improving the maturity of the Quality systems and procedural lifecycles owned by Product Quality, and ensuring global product teams and site Quality teams deliver on departmental and corporate milestones across the product development lifecycle.

The Manager, Product Quality Operations and Stability, should have a good understanding of quality systems, Quality Assurance, Quality Control, document management best practices and lifecycle, analytical methodologies, tracking and trending best practices using statistical approaches, and regulatory requirements across the product development lifecycle.

 
Essential Functions and Responsibilities

• Must have a strong Quality mindset with knowledge of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA, etc.) requirements for cell therapies and biologics

• Strong technical writing skills
• Experience authoring and compiling information for annual reports and/or APQR

• Communicates and collaborates within function and with cross-functional stakeholders with clarity and transparency.

• Must be able to recognize problems and effectively communicate and collaborate with stakeholders to assess and document risks, implement mitigations, and escalate within and across project teams and to management.
• Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
• Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
• Must manage problems of diverse scope and demonstrate ability to translate complex issues in a concise manner.

• Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
• Monitors analytical method performance across network to ensure consistency and that assay controls, critical reagents, and reference materials are appropriately qualified prior to implementation.
• Operates at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
• Performs duties with a high level of autonomy and with minimal supervision and oversight.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Supports and performs other activities as assigned.

Travel

• Some travel (< 10%) may be required.

Required Education, Skills, and Knowledge

• Bachelor’s degree with at least 8 years of experience in a relevant discipline (biological sciences or equivalent).
• Broad knowledge of cell therapy and biologics product development with respect to stability programs, stability-indicating methods, Quality Control, and regulatory guidance.
• High degree of proficiency in statistical methodology and software (e.g., JMP, Minitab) commonly used for evaluation of data generated with cell therapy products.
• Able to successfully interface with cross-functional teams, network within and across functions both internally and externally, and build and maintain collaborative and trusting relationships
• detail-oriented and organized with strong analytical, written, and verbal communication skills with right-first-time mentality and approaches.
• Ability to effectively manage multiple priorities involving aggressive timelines and consistently deliver on time.
• Demonstrate sense of urgency; ability to recognize and meet time sensitive demands.
• 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

• Master’s degree with 6 years of relevant experience or Ph.D. with 4 years of experience preferred.
• Experience with cell and/or gene therapies and associated key and critical starting materials is a plus.
• Experience managing stability programs including authoring stability protocols, oversight of stability testing, data analysis, statistical trending, and interpretation, and authoring stability reports according to global current good manufacturing practices (cGMP) and ICH guidelines across all Iovance network sites/partners and programs.

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 operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

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.

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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