Senior Process Development Associate [Contract to Hire]

Overview

The Senior Process Development Associate will support process development, technology transfer, and external vendor management activities related to genetically and non-genetically engineered Tumor Infiltrating Lymphocyte (TIL) programs. The successful candidate will have extensive experience with aseptic cell culture techniques, preferably T cells or other immune cells, and previous experience in process development or manufacturing sciences with some knowledge of cGMP/cGLPs. This role is a lab-based and will report to Iovance’s Tampa, FL facility.

Essential Functions and Responsibilities:

·       Process development and characterization supporting TIL clinical trials. Perform unit operations including, but not limited to, media optimization, mammalian cell culture, genetic modification using mRNA or lentivirus, drug product formulation, and cryopreservation of cell products. 

·       Design development and characterization studies with some autonomy. Write protocols, execute studies, analyze data, author reports, and orally present findings.

·       Provide support for external contract manufacturers, including document reviews (protocols, reports, batch records) and managing shipping logistics

·       Support technology transfer of process to internal and/or external manufacturing partner(s). Partner with MSAT and Operations to facilitate technology transfer (MBR creation, training, on-going technical support).

·       Provide support related to data and records management

·       Remain current with new processes and analytical methods.

·       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 all other related duties as assigned

Required Education, Skills, and Knowledge

·       Bachelor’s degree with 5 yrs or Master’s degree with 3 yrs in chemical engineering or STEM-related discipline

·       2 years of cell culture/ cell therapy biotechnology life science industry experience

·       Proficiency in Microsoft Office Suite

·       Must be able to comprehend regulations and guidance documents

·       Must be analytical and able to apply critical thinking

·       Effective written and oral communication skills

·       Must be organized, able to multi-task

·       Work well in team environment

Preferred Education, Skills, and Knowledge

·       Previous cell therapy experience.  Experience with TIL or CAR-T is an added plus

·       Experience with MS Project, Smartsheets, or similar project management software

·       Proficiency in Graph Pad, MiniTab

·       Experience with automated instruments such as Miltenyi Prodigy, Lovo, Sepax, Rotea, and/or similar

·       Previous work with cell-based or flow analytical assays is a plus.

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.

·       Must be able to move and lift containers of fluid weighing up to 15 pounds multiple times a day

·       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 hr@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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