Quality Control Microbiologist I

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Position Overview

Salary:

Summary:

The Quality Control Microbiologist will play a crucial role in ensuring the integrity of quality control testing operations at Iovance Biotherapeutics Inc. This position involves overseeing microbial testing programs for both in-process and final drug products, focusing on essential aspects such as bioburden, endotoxin, gram staining, environmental assessments, and sterility procedures.

Key Responsibilities:

  • Conduct daily cGMP microbiological testing within the quality control laboratory.
  • Execute scheduled environmental monitoring in cleanroom environments.
  • Analyze data and report results of microbiological assays to facilitate product lot release, ensuring adherence to established turnaround times.
  • Maintain compliance with cGMP regulations throughout all activities.
  • Assist in comprehensive investigations related to out-of-specification test outcomes.
  • Trend environmental monitoring data effectively.
  • Provide support for technical troubleshooting as needed.
  • Contribute to product stability initiatives, including the execution of stability tests, data analysis, and final reporting.
  • Consistently operate at a high level of efficiency, delivering precise and high-quality results.

Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • A minimum of one (1) year of experience in a Quality Control role within the pharmaceutical sector; experience with cell therapy products is advantageous.
  • Ability to collaborate effectively with multidisciplinary teams.
  • Strong attention to detail and technical proficiency.
  • Capacity to manage multiple priorities while meeting stringent deadlines.
  • Demonstrated ownership and accountability in work responsibilities.
  • Exhibit a sense of urgency and recognize the importance of time-sensitive tasks.

Physical Requirements:

  • Must be able to wear appropriate cleanroom attire and Personal Protective Equipment (PPE).
  • Must meet criteria for wearing a half-face respirator.
  • Able to stand and/or walk for the majority of a 10-hour shift, which may include climbing.
  • Must possess near vision capabilities for close sample examination.
  • Ability to perform physical activities including bending, reaching, and lifting objects up to 45 pounds.

Mental Requirements:

  • Strong analytical and problem-solving skills; ability to manage work-related stress and prioritize multiple tasks effectively.

Work Environment:

  • This role involves working in both office and laboratory settings.
  • Exposure to various chemicals and biohazards is expected in the lab environment.
  • Potential exposure to noise and equipment hazards.

The information provided in this document is intended to outline the general nature and level of work performed by individuals in this position. It is not intended to be an exhaustive list of all responsibilities, duties, or local variations. Management reserves the right to modify job duties as necessary.

Iovance Biotherapeutics Inc. is dedicated to fostering a diverse and inclusive workplace. We are an equal opportunity employer and consider all qualified 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.

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