Overview
The Analytical Sciences & Technology (AS&T) Specialist is responsible for supporting Quality Control (QC) compliance through data trending, investigation management, and the initiation and execution of change controls and Corrective and Preventive Actions (CAPAs) related to analytical and microbiological testing of products. This role conducts and supports investigations in accordance with cGMP and FDA regulations, as well as Iovance policies and standard operating procedures, ensuring timely resolution and closure of QC-related events. Given the complexity of the manufacturing and testing environment, the position requires strong technical expertise, a thorough understanding of QC compliance requirements, and strong technical writing skills.
In addition, the AS&T Specialist supports the technical development and continuous improvement of QC methods and processes, including method development, validation, instrument qualification, and technology transfer activities for analytical and microbiological testing. The role is also responsible for the operation and maintenance of AS&T owned equipment, ensuring all activities are performed in compliance with applicable regulatory requirements, internal procedures, and quality standards.
Essential Functions and Responsibilities
- Performs data trending of assay controls and compiles associated metrics, authors quarterly reports, and communicates OOT results for investigation.
- Performs root cause analysis and investigations in response to audits, deviations, out of specification/lab investigations, corrective/preventative actions (CAPA) and initiates change controls as required.
- Work cross-functionally to support deviations and Out of Specification investigations with an emphasis on analytical assays (flow cytometry, ELISA, and other cell-based assays) and Microbiology assays.
- Gather data in support of deviations and maintain a trending database of applicable metrics.
- Perform investigational testing in the laboratory, as required.
- Revise Quality documents in support of deviation mitigation and/or CAPAs.
- Supports Phase I/II LIR OOS/OOT investigations and testing.
- Responsible for the timely completion of required trainings.
- Prepares applicable documents and records, such as investigational analyses summaries or testing record, and follows Good Documentation Practices.
- Supports testing for method and instrument implementation, as well as qualification/validation protocols, as needed.
- Responsible for timely completion of required training, including SOPs, aseptic techniques, gowning, testing, and HSE.
- Supports preparation of applicable documents, forms, and records, such as method or instrument qualification/validation records, and follows Good Documentation Practices.
- Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Performs miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Minimum of a Bachelor’s degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field and at least 3 years of experience is required.
- Solid understanding and functional knowledge with the following: Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines).
- 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)
Preferred Education, Skills, and Knowledge
- Master’s degree with 4 years of experience.
- Experience with cell therapy products 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 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
- 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.
