Manufacturing Specialist

3 weeks ago


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

Overview

Iovance Biotherapeutics Inc is a leading immune-oncology company focused on developing and commercializing novel cancer immunotherapies based on TIL. Our team is seeking a highly skilled Manufacturing Specialist to join our GMP manufacturing operations. The successful candidate will be responsible for supporting the development and launch of our assets, ensuring compliance with regulatory requirements, and contributing to the improvement of our manufacturing processes.

Key Responsibilities

  • Support the development and implementation of SOPs, batch records, deviations, and CAPAs to ensure compliance with GMP regulations.
  • Lead teams in investigating minor, major, and critical nonconformances and deviations, including root cause analysis and deviation report drafting.
  • Manage change controls associated with manufacturing areas and equipment.
  • Participate in technology transfer, conference calls, and sharing of technical information.
  • Coordinate front-end document requests with supporting departments.
  • Ensure timely resolution of deviations and CAPAs, and review and approval of batch records.
  • Continuously seek and support new approaches, practices, and processes to improve document review and revision efficiency.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Attend weekly management meetings to discuss timelines and priorities.
  • Contribute to projects to ensure timely initiation and completion of work.
  • Troubleshoot issues and prioritize workload to solve moderately complex problems.
  • Ability to work in a team environment and independently as required.
  • Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements.
  • Review data generated/collected by less experienced technical staff.
  • Must adhere to Iovance Biotherapeutics Inc's core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.

Requirements

  • Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 2 years of experience in biopharmaceutical-based GMP manufacturing operations.
  • Demonstrated strong technical knowledge of aseptic processing in cleanroom environments.
  • Ability to build relationships quickly and credibly, with excellent support to staff.
  • Proactive, results-oriented, self-starter with strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity and manage constant change.
  • Ability to work successfully in a fast-paced, team-oriented environment.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent presentation skills, both written and verbal.
  • Understands and complies with quality standards and requirements as documented.
  • Strong computer skills, problem-solving, and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES).
  • Able to work independently with minimal supervision.
  • Must adhere to Iovance Biotherapeutics Inc's core values, policies, procedures, and business ethics.
  • This position is currently for regular work week hours (1st shift M-F).
  • Need to be able to read, write, and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Physical Demands and Activities Required

  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
  • Able to stand and/or walk 90% (and sit 10%) which may include climbing ladders or steps.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 45 pounds.

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 manufacturing cleanroom setting.
  • When in the lab, must be able to work in cleanroom setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.


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