Senior MSAT Specialist - 2nd Shift

Overview

The Senior MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert.  The MSAT Senior Specialist reports to the Director, MSAT and is responsible for manufacturing data analysis, contributing to deviation root cause analysis and owning steps of the manufacturing process tech transfer.  The Senior MSAT Specialist is also responsible for protocol and report authoring, technical oversight of manufacturing operation execution, and execution of MSAT laboratory activities.

Shift: Monday to Friday from 3:00pm - 11:30pm

Essential Functions and Responsibilities

• Serve as a manufacturing processes technical SME representing MSAT during cross functional meetings.
• Serve as primary MSAT POC for study, clinical, and commercial manufacturing execution escalations for multiple cell and gene therapy GMP Processes. Perform Person-In-Plant (PIP) responsibilities at CMOs managing production execution at external manufacturing facilities. Ensure alignment of manufacturing practices at all manufacturing facilities.
• Provide MSAT oversight, training, and support within the manufacturing cleanroom environment as well as assist with onboard training of new MSAT specialists.
• Manage and own Technology Transfer campaigns of new product introduction, and process improvements to internal and external manufacturing facilities. Provide hands-on manufacturing process training to manufacturing personnel as part of process tech transfer as needed.
• Senior MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation:
• Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution)
• Study or investigational protocols and corresponding reports
• Process Characterization, Validation, Qualification protocols and reports
• Product Impact and Risk Assessments, Failure Modes Risk Analysis
• SOPs, COPs, MSAT MBRs
• Senior Specialists will be responsible for managing MSAT department Quality System metrics and managing complex investigations (CAPA, Deviation, etc.) related to the manufacturing process. Investigation activities may include execution of studies, GEMBA, Kaizen, Risk Analysis, etc. through to completion.
• Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Will assist manufacturing and quality when authoring Master Batch Records and implementing process improvements.
• Analyze and interpret manufacturing process data and ensure process trends are addressed appropriately. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the manufacturing operations environment.
• Execute hands on experiments in the MSAT lab (as applicable).
• 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

• B.S degree in a relevant discipline or equivalent industry experience.
• A minimum of 5 years of relevant hands-on operations experience for clinical or commercial production and/or process development experience in the life sciences industry.
• Expertise in cell culture and aseptic technique.
• Knowledge and understanding of GMP systems within a manufacturing facility.
• Ability to organize, analyze manufacturing process data, and provide potential process improvements.
• Knowledge and expertise in manufacturing process tech transfer. Involvement in prior manufacturing process tech transfer is required.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to work cross functionally within the organization as part of a project team.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Must be comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Preferred Education, Skills, and Knowledge

• Prior cell therapy experience is highly preferred.

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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