Manager, MSAT & External Manufacturing

Overview

The Manager, MSAT and External Manufacturing is a Manufacturing Operations cell therapy subject matter expert that will actively collaborate with Quality, Regulatory, Manufacturing Operations, Process Development, and our Contract Manufacturing Organizations (CMO). The Manager, MSAT and External Manufacturing will lead a team of MSAT Specialists providing support and oversight of internal and external manufacturing of Iovance therapies.  The position is responsible for the transfer and implementation of projects, processes, and technology from process development to manufacturing sites for Iovance cell therapy products. 

This position will assist the Senior Director of MSAT and External Manufacturing in planning, coordinating, and overseeing manufacturing and manufacturing related activities through the product life cycle which includes development, stability, and product validation batches across manufacturing sites. This position will support manufacturing activities at the various manufacturing sites as a Person-in-Plant (PIP).  The PIP will be critical in the ongoing training of manufacturing staff, drive/own deviation investigations, provide product quality impact assessments, and assist in qualification and validation activities at the manufacturing site.  The Manager, MSAT and External Manufacturing will own and delegate change controls and CAPAs pertinent to manufacturing operations across multiple manufacturing sites.

Essential Functions and Responsibilities

• Leads a team of MSAT Specialists providing internal and external oversight and support of manufacturing activities.
• Serves as PIP overseeing manufacturing operations at CMOs.
• Provides training to new manufacturing operators at CMOs.
• Conducts process audits of manufacturing operations across manufacturing sites ensuring continuity and reproducibility in execution of Iovance cell therapy processes.
• Drives complex change controls and tech transfers at manufacturing sites.
• Own Stage 2 (PPQ) of Process Validation and assist in the development, implementation, and maintenance of Stage 3 (CPV).
• Utilizes technical writing strategies to ensure change control content is clear, concise, and complete.
• Ensures timely progression of change controls through the various phases of the change management process.
• Ensures operational readiness for process transfers and change controls, including; the facility, equipment, documentation, and staff.
• Executes process transfers into the existing manufacturing structure, including SOPs, batch records, work instructions, and training curricula.
• Initiates, revises, and approves manufacturing procedures. Ensures all procedures reflect current operations. Serves as a document reviewer, owner, and approver as appropriate.
• Prepares for, and participates in, regulatory inspections.
• Utilizes strong operational excellence / lean principles, business acumen, quality-mindedness, and exceptional communication skills to develop streamlined, efficient, and robust systems, and to affect positive change.
• Contributes to the development of manufacturing strategies for resolving complex issues related to new process transfers to manufacturing sites.
• Authors, reviews, and approves risk assessments, protocols, manufacturing batch records and supporting documentation for regulatory submissions.

Required Education, Skills, and Knowledge

• Bachelors in relevant discipline, plus 6 years of related industry experience
• Must possess a thorough understanding of cell therapy manufacturing.
• Must be able to translate bio-tech processing into documentation such as batch records, protocols, and SOPs.
• Must possess strong verbal and written communication skills.
• Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including management or inspectors.
• Technical writing must be at an advanced level with proficient spelling, grammar, and typing skills. Ability to understand and teach technical writing skills and minimize risk of misinterpretation.
• Exhibits leadership behaviors including collaborating for results and developing/executing strategy.
• Strong ability to influence in a team environment and collaborate with peers.
• Must be able to create an environment that encourages continuous improvement, best practices and appropriate risk taking.
• Must have experience working in various Quality Systems, understanding of facility technology, system troubleshooting, CAPA's and change controls.
• Ability to perform gowning activities and enter the manufacturing plant.
• Project Management experience with prior experience managing multiple assignments and processes while developing practical and thorough solutions for complex issues.
• Ability to meet objectives and perform with a high degree of accuracy. Expert in Microsoft Office 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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• Must be able to move to and from the office to the lab located on separate floors and move about the office and lab as needed.
• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to grasp with both hands, perform repetitious actions such as pinch with thumb and forefinger, turn with hand/ arm, and reach above shoulder height.
• Must be able to use several types of laboratory equipment and pipettes for extended periods.
• Must be able to work on a tablet or computer typing for 50% of a typical working day.
• Must be able to move and lift 20 pounds multiple times daily.
• Must be able to use near vision to view samples at close range.
• Wear proper personal protective equipment when in a laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

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 careers@iovance.com.

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