Analytical Sciences Specialist
1 week ago
We are seeking a highly skilled Biotechnology Specialist to join our team at Iovance Biotherapeutics, Inc. as an Analytical Sciences Specialist. This role will be responsible for the technical development of quality control methods and processes, method and instrument validations, and technical transfers related to Analytical and/or Microbiological quality control testing of products, raw materials, and packaging components at the site.
Key Responsibilities- Execute testing for method and instrument implementation and qualification/validation protocols.
- Support Phase II LIR OOS/OOT investigational testing.
- Responsible for the timely completion of required tasks, including SOPs, aseptic techniques, gowning, testing, and EHS.
- Prepare applicable documents, forms, and records, such as method or instrument qualification/validation records, and follow Good Documentation Practices.
- Support internal and external Audits and Inspections, if needed.
- Adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
- A minimum of a bachelor's degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field and 1-3 years of GMP experience is required.
- Solid understanding and functional knowledge with hands-on experience with Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays.
- Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.).
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate a sense of urgency; ability to recognize time sensitivity.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
- Master's degree with four years of experience.
- Experience with cell therapy products is a plus.
- 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 90% (and sit 10%) 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.
- 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.
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