MSAT Supervisor

Overview

The MSAT Supervisor/Manager‘s role is integral to ensuring effective execution of manufacturing related investigations according to regulatory guidelines as well as execution and development of protocols related to process improvement. The MSAT Supervisor/Manager will also lead the development and manage the MSAT specialists and managers training program. The ideal candidate will have a deep understanding of cell therapy manufacturing and development.

Essential Functions and Responsibilities

• Develop and manage training programs for MSAT specialists and managers.
• Develop and manage the Positive Control manufacture at the MSAT lab.
• Lead investigation plans, associated protocols, and reports for ongoing root cause analyses.
• Lead and mentor a team of MSAT specialists to ensure timely progression of root cause analyses, deviations or change controls through the various phases of the processes.
• Develop manufacturing strategies for resolving complex issues related to manufacturing investigations and process improvement.
• Evaluate, develop, and implement new technical and manufacturing procedures.
• Serves as a document reviewer, owner, and approver as appropriate.
• Assist with maintaining global alignment of manufacturing processes across internal manufacturing facilities and CMOs.
• Assist with COGS reduction projects planning, execution, technology transfer and implementation at manufacturing sites as required.
• 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.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge

• Bachelors in relevant discipline or equivalent in work experience for supervisor
• Must possess a thorough understanding of cell therapy manufacturing.
• Prior training experience preferred.
• 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 preferred.
• 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

• 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 (2-4 hours).
• 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 work on a tablet or computer typing for 50% of a typical working day.
• Must be able to move and lift 15 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.

 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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