Location: Tampa,FL, USA
Overview
The Scientist-II, Process Development will be responsible for in-house lentiviral (LV) process development, evaluation of LV vectors, collaborating with the analytical department (AD) to development new LV-related assays/methods, and supporting external LV-related manufacturing operations. This person is expected to be a subject matter expert (SME) in LV biology and LV production with good working knowledge of cGMPs/cGLPs. This role is a lab-based role and will be based out of Iovance's Tampa, FL facility.
Essential Functions and Responsibilities
* Function as team's LV SME. Support LV manufacturing and TIL transduction development, interface with external LV manufacturing partners, contribute to regulatory filings.
* Lead in-house LV development activities, including production and evaluation of in-house produced LV, evaluation of externally produced LV, development of new methods, and may include cell line development. Evaluation techniques may include flow cytometry, cell counting, qPCR, and cell-based assays.
* Design development and characterization studies with high degree of autonomy. Write protocols, execute studies, analyze data, author reports, and orally present findings.
* Assist teammate in managing external LV manufacturing (plasmid production through LV manufacture). Help guide external development and manufacturing activities.
* Partner with AD on assay/method development, Research on LV process development, process development (PD) on TIL PD (especially with regards to the transduction step), MSAT/ASaT and Operations on technology transfer of processes and methods, and external manufacturing partners.
* Support manufacturing investigations and on-going process development activities, as needed.
* Evaluate new technology and automation
Required Education, Skills, and Knowledge
A minimum of a bachelor's degree in chemical engineering, immunology, biology, microbiology, or related scientific field and 14+ years of industry experience is required; or a master's degree with 12+ years of industry experience; or a Ph.D. with 6-8 years of industry experience.
* Excellent working knowledge of lentivirus biology and production with deep understanding of factors affecting LV quality, titer, and ability to transduce.
* Experience with flow cytometry to evaluate gene expression and other expression and/or titration methods.
* Strong technical writing and oral communication skills.
* Ability to effectively manage multiple priorities involving aggressive timelines at a high level of autonomy.
* Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
* Role may require up to 10% travel, as needed.
Preferred Education, Skills, and Knowledge
* Experience with cell therapy products, especially CAR-T, is a plus.
* Experience with large scale LV manufacturing (either hands-on or managing external partner).
* Authoring sections of regulatory filings (IND/IMPD, amendments, BLA/MAA, IRs)
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Physical Demands and Activities Required
* Must be able to wear appropriate Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
* Must be able to work in a lab setting with biohazards / various chemicals.
* Able to stand and/or walk 70% (and sit 30%) within your scheduled workday, which may include climbing ladders or steps.
* Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
* Must be able to lift and carry objects weighing up to 45 pounds
* 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 when not in a lab setting.
* Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
* 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 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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position's responsibilities 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 ...@iovance.com
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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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