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Quality Control Analytical Specialist
2 months ago
Position Title: Analytical Sciences & Technology Specialist I
Salary: Competitive
Summary:
The Analytical Sciences & Technology Specialist I plays a pivotal role in the technical advancement of quality assurance methodologies and processes. This includes the validation of methods and instruments, as well as the technical transfer related to Analytical and/or Microbiological quality control assessments of products, raw materials, and packaging components. The incumbent is also tasked with the operation and maintenance of quality control instruments in alignment with cGMP/FDA regulations and Iovance's standard operating procedures.
Work Schedule: Sunday - Thursday, 8:30 AM - 5:00 PM
Key Responsibilities:
- Conducts testing for the implementation and qualification/validation of methods and instruments.
- Assists in investigational testing for Phase II LIR OOS/OOT.
- Ensures timely completion of essential tasks, including SOPs, aseptic techniques, gowning, testing, and EHS compliance.
- Prepares necessary documentation, including method or instrument qualification/validation records, adhering to Good Documentation Practices.
- Supports internal and external audits and inspections as required.
- Upholds Iovance Biotherapeutics' core values, policies, and ethical standards.
- Performs additional duties as assigned.
Qualifications:
- Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or a related scientific discipline, with 1-3 years of GMP experience.
- Strong understanding and hands-on experience with Flow Cytometry, Cell-based ELISA, cell culture (primary cells and cell lines), and molecular assays.
- Proficient in technical writing, including test methods, SOPs, and protocols.
- Ability to collaborate effectively with multidisciplinary teams.
- Detail-oriented with robust technical capabilities.
- Proven ability to manage multiple priorities under tight deadlines.
- Demonstrates a high level of ownership and accountability.
- Exhibits a sense of urgency and recognizes time-sensitive tasks.
- Proficient in Microsoft Office Suite (Outlook, Excel, Word, PowerPoint).
Preferred Qualifications:
- Master's degree with four years of relevant experience.
- Experience with cell therapy products is advantageous.
Physical Requirements:
The physical demands outlined here are essential for the successful performance of this role. Reasonable accommodations may be provided upon request to enable individuals to perform essential functions.
- Ability to wear appropriate Personal Protective Equipment (PPE), including scrubs, gowns, masks, and gloves.
- Capability to work in a laboratory environment with biohazards and various chemicals.
- Must be able to stand and/or walk for 90% of the workday, with occasional sitting.
- Ability to lift and carry objects weighing up to 45 pounds.
- Must have visual acuity for data analysis and extensive reading.
- Requires repetitive motion and substantial wrist, hand, and finger movements.
- Effective communication skills to exchange information with colleagues.
Mental Requirements:
Clear and conceptual thinking ability; excellent judgment and problem-solving skills; capacity to manage work-related stress; ability to prioritize multiple tasks and meet deadlines.
Work Environment:
This position operates in both an office and laboratory setting, with potential exposure to hazardous or biological waste during various processes.
Iovance is dedicated to fostering a diverse and inclusive workplace. As an equal-opportunity employer, we consider all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.
