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Specialist /Senior Specialist, Quality Control External Operations (Contract)

Iovance Biotherapeutics Inc
Philadelphia, PA
  • Expired: May 20, 2022. Applications are no longer accepted.

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a contract Sr. Specialist/ Specialist Quality Control, who will be responsible for oversight of day-to-day quality control operations for the development and manufacture of early phase through commercial cell therapy programs. S/he must have a good understanding of Quality Control and apply practical knowledge of phase appropriate GMPs and regulatory requirements in the product development life cycle, including but not limited to: lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. Experience working in a GMP-regulated environment is essential, including knowledge of health authority expectations for novel and complex oncology programs. The position will report to the Associate Director, Quality Control.

Specific Responsibilities

  • Manage day-to-day GMP QC testing activities for lot release across CMO and CTL network ensuring alignment with approved methods and regulatory requirements and ensure practices are compliant with global current good manufacturing practices (cGMP) and ICH guidelines.
  • Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents.
  • Coordinate all quality control-related activities with respect to timelines and compliance
  • Manage sample testing schedule, shipment, receipt, CoA reviews to support testing of various stages of pipeline, ensure deadlines are met.
  • Facilitate thorough GMP investigations for out of specification test results and corrective actions
  • Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment
  • All duties are performed with minimal supervision and oversight

Education and Qualifications:

  • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
  • Broad knowledge of biological drug development with respect to Quality Control
  • Minimum (6) years of experience in the biopharmaceutical industry within a Quality Control role; experience with cell and/or gene therapy products is a plus
  • Successfully interface with multi-disciplined teams in a global setting
  • Extremely detail-oriented with strong analytical, written, and verbal communication skills
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
  • Demonstrate sense of urgency; ability to recognize time sensitivity
  • Flexible and adaptable style with an eagerness to take on challenges
  • Problem solver who not only identifies issues but leads efforts to resolve them

Physical Requirements:

  • Sit for an extended amount of time in front of the computer

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Employment Type: CONTRACTOR

Iovance Biotherapeutics Inc

Address

Philadelphia, PA
19112 USA

Industry

Manufacturing

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