Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Overview
The Analytical Sciences & Technology Specialist I participates in laboratory activities to support process development, support the development, qualification, and validation of analytical methods, perform product characterization for TIL therapies, and support critical reagent/materials selection, qualification, and testing programs. In this role, you will be involved in assay qualification, validation, optimization, standardization, and transfer of analytical and/or microbiological methods. Under reasonable supervision, you will support assay development experiments, carefully document methods and materials, assist with drafting SOPs/reports, and communicate findings. The ideal candidate demonstrates foundational skills and knowledge in process and analytical development and is excited to take on new challenges in a fast-paced and dynamic environment.
Essential Functions and Responsibilities
- Support the development of analytical and/or microbiological methods involving a variety of protocols and techniques.
- Make detailed observations and record them in a timely and relevant fashion.
- Performs assays for process assessment and characterization.
- Assist with analysis and interpretation of experimental results.
- Organize results for team presentation and discussion.
- Assist with drafting test methods, technical protocols and reports, and standard operating procedures (SOPs).
- Sets up, monitors, samples, and analyzes cell culture processes.
- Work with various internal teams to better understand the analytical methods for characterizing product critical quality attributes.
- Supports Quality Control group by performing training, support testing, and validation execution.
- Ensure training is up to date on new processes and analytical methods.
- Compliance and maintenance of lab safety, environment, and quality.
- Perform duties and responsibilities with proficiency and conformance to internal standard operating procedures and international governing procedures and standards.
- Familiar with ICH and FDA guidance and USP standards.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Minimum of 2 years of related experience with a bachelor’s degree, or an advanced degree without experience; or equivalent work experience.
- Hands-on cell culture and associated lab experience.
- Experience with microbiological techniques such as microscopy (gram stain) and growth promotion
- Proficiency in Microsoft Office Suite and spreadsheet programs required.
- Proficiency in graphing and statistical software.
- Must comprehend regulations and guidance documents and apply critical thinking. Skills to evaluate requirements and effectively communicate (written and oral) findings.
- Strong interpersonal, written, and oral communication skills are required.
- Must be organized, multitask, and be a team player.
- Comfortable working in an agile environment and adjusting priorities as needed.
Preferred Education, Skills, and Knowledge
- Foundation in experimental documentation, fundamental statistical analysis, and data presentation
- Experience with sterility testing, endotoxin testing, mycoplasma testing.
- Basic skills in molecular techniques, including qPCR or ddPCR.
- Experience with drafting SOPs and forms
- Exposure to assay development, cell product release testing, characterization studies, or design of experiment (DoE) approaches 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
- 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 and perform repetitious actions such as pinching with the thumb and forefinger, turning with the hand/ arm, and reaching 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.
#LI-onsite
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 [email protected].
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.
Skills Required
- Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field
- 1-3 years of relevant laboratory experience
- Hands-on experience with Flow Cytometry, cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays
- Experience executing method and instrument qualification/validation protocols and technical transfers
- Proficient technical writing skills (test methods, SOPs, protocols) and Good Documentation Practices
- Familiarity with aseptic techniques, gowning, sterility principles, and laboratory EHS practices
- Ability to interface with multi-disciplined teams and manage multiple priorities under aggressive timelines
- Proficient with Microsoft Office applications (Outlook, Excel, Word, PowerPoint)
- Master's degree with four years of experience
- Experience with cell therapy products
What We Do
Iovance Biotherapeutics (NASDAQ: IOVA) aims to improve patient care for people living with cancer. Iovance is investigating T cell-based therapies, known as tumor infiltrating lymphocytes (TIL), which use a patient’s own immune cells to attack cancer. Our unique Iovance TIL technology platform has generated novel cell therapies that are currently in clinical studies for multiple cancers. We are adding to our talented team as we actively prepare for our initial commercial launch, advance our research and development efforts, and build our internal manufacturing capabilities. Iovance is headquartered in the San Francisco Bay Area. Our Iovance Cell Therapy Center (iCTC), a state-of-the-art manufacturing facility, is located in Philadelphia. We also have a research site in Tampa, Florida. Any information expressed by Iovance is subject to the risk factors and information on forward-looking statements contained in its filings with the Securities and Exchange Commission and available here: https://ir.iovance.com/sec-filings
