Manufacturing Operations Specialist

1 week ago

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

Position Summary:
Iovance Biotherapeutics Inc. is a pioneering company in immune-oncology, dedicated to the advancement and commercialization of innovative cancer immunotherapies utilizing Tumor Infiltrating Lymphocytes (TIL). Our flagship product is an autologous, ready-to-administer cell therapy that has shown remarkable effectiveness in treating metastatic melanoma. We are expanding our commercial manufacturing capabilities to support the development and launch of various clinical assets currently in progress.

Key Responsibilities:

  • Assist in the preparation and approval of essential documentation, including Standard Operating Procedures (SOPs), Batch Records, and corrective actions.
  • Lead investigations into nonconformances and deviations, utilizing structured root cause analysis to draft and amend reports as necessary.
  • Manage change controls related to manufacturing processes and equipment.
  • Engage in technology transfer and facilitate technical information sharing.
  • Coordinate document requests with relevant departments to ensure compliance.
  • Ensure timely resolution of deviations and corrective actions, while overseeing the review and approval of Batch Records.
  • Continuously explore and implement innovative practices to enhance the efficiency of document management.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), ensuring compliance with regulatory standards.
  • Participate in weekly management meetings to discuss project timelines and priorities.
  • Contribute to various projects to ensure timely execution and completion of tasks.
  • Address moderately complex operational issues independently, ensuring minimal disruption to manufacturing activities.
  • Provide troubleshooting support and prioritize tasks to resolve operational challenges.
  • Collaborate effectively within a team environment while also demonstrating the ability to work autonomously.
  • Ensure the accuracy and completeness of raw data records, adhering to protocol specifications and GMP requirements.
  • Comply with safety protocols and laboratory procedures as per company policy.
  • Perform additional duties as assigned.

Travel Requirements:
Occasional travel may be necessary, up to 10%, based on business needs.

Qualifications:

  • Bachelor's degree in biology, biochemistry, bioengineering, or a related technical field, or equivalent experience in the industry.
  • A minimum of 2 years of experience in GMP manufacturing operations within the biopharmaceutical sector.
  • Strong technical knowledge of aseptic processing in cleanroom environments is essential.
  • Proven ability to build relationships and provide exceptional support to staff across diverse teams.
  • Results-driven, proactive individual with demonstrated leadership skills in a complex manufacturing setting.
  • Adaptability to manage changing priorities and navigate ambiguity effectively.
  • Ability to thrive in a fast-paced, collaborative environment.
  • Familiarity with quality standards, including 21 CFR Part 11 and GxP best practices.
  • Excellent communication skills, both written and verbal.
  • Strong organizational skills and attention to detail, with proficiency in data management systems.
  • Ability to work independently with minimal supervision.
  • Compliance with Iovance Biotherapeutics' core values and ethical standards is mandatory.
  • This position operates primarily during standard business hours.
  • Proficiency in English and Microsoft Office Suite (Excel, Word, Outlook) is required.

Physical and Mental Demands:
The role requires the ability to wear appropriate cleanroom attire and personal protective equipment. Candidates must be able to stand or walk for the majority of the workday, perform repetitive motions, and lift objects weighing up to 45 pounds. Strong analytical and problem-solving skills are essential, along with the ability to manage multiple priorities and meet deadlines.

Work Environment:
This position involves working in both an office and a cleanroom manufacturing environment, with potential exposure to various chemicals and biological materials.

Iovance is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer, and all qualified applicants will be considered 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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