Msat Specialist

Overview

Iovance is seeking an MSAT Specialist who is a Manufacturing Operations PBMCs-based product subject matter expert. The MSAT Specialist will report to the Sr. MSAT Manager and be responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning steps of the manufacturing process tech transfer. The MSAT Specialist will also be responsible for protocol and report authoring, oversight of manufacturing operations, and execution of MSAT laboratory activities.

Responsibilities

• Serve as a manufacturing processes technical SME representing MSAT during cross-functional meetings.

• Serve as MSAT POC for clinical and commercial manufacturing execution escalations for PBMCs-based GMP Processes. Perform Person-In-Plant (PIP) responsibilities observing production and providing real-time feedback support during internal manufacturing execution.

• Help support alignment of manufacturing practices across multiple manufacturing facilities.

• Provide MSAT oversight, training, and support within the manufacturing cleanroom environment.

• Execute Technology Transfer responsibilities related to new product introduction or process improvements to internal and external manufacturing facilities. Provide hands-on manufacturing process training to manufacturing personnel as part of process tech transfer in suite as needed.

• The MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation:

• Quality Systems (minor to complex) - Change Controls, Deviations, CAPAs, Action Items, Laboratory Investigations

• Minor Study or investigational protocols and corresponding reports

• Process Characterization, Validation, Qualification protocols and report amendments

• Product Impact and Risk Assessments, Failure Modes Risk Analysis

• SOPs, MSAT MBRs

• MSAT Specialists will be involved in execution of investigation activities which may include execution of studies, GEMBA, Kaizen, Risk Analysis etc.

• 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. 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).

Position Requirements

• B.S degree in a relevant discipline or equivalent industry experience.

• A minimum of 3 year of relevant hands-on operations experience for clinical or commercial production and/or process development experience in the life sciences industry. Prior cell therapy and/or PBMC-based product experience is highly preferred.

• Expertise in aseptic technique.

• Knowledge and understanding of GMP systems within a manufacturing facility.

• Ability to organize and analyze manufacturing process data.

• Knowledge of manufacturing process tech transfer. Involvement in prior manufacturing process tech transfer is preferred.

• 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.

• Involvement in prior manufacturing process tech transfer is 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.

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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