Senior Quality Control Specialist, LIMS

4 weeks ago

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

Iovance Biotherapeutics Inc is hosting an onsite Job Fair to connect with talented professionals.

Event Details

  • Location: Iovance Cell Therapy Center (iCTC)
  • Address: 300 Rouse Blvd, Philadelphia, PA 19112
  • Date: Wednesday, October 23, 2024
  • Time: 12pm to 6pm (EDT)

What to Expect

Meet our team and learn about our company culture, benefits, and career opportunities. We're looking for a Senior Quality Control Specialist, LIMS to join our team.

Job Summary

The Senior Quality Control Specialist, LIMS will be responsible for deploying and administering the QC Laboratory Information Management System (LIMS). This role will represent QC in the development, configuration, validation, implementation, and maintenance of the LIMS as it relates to QC functionality, including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability, and sample management to support compliance with regulatory requirements and commitments for clinical and commercial products.

Key Responsibilities

  • Understand and execute change management in a GMP environment and drive changes through the appropriate quality system.
  • Support deviations and LIRs with LIMS information as needed.
  • Collaborate with stakeholders to develop the requirements and the long-term vision for LIMS.
  • Drive development and implementation of the LIMS by partnering with IT and external vendors.
  • Develop and regularly update key project information such as status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.
  • Manage enhancements, incident investigation, and changes for a multi-site, global LIMS.
  • Draft program-related support documents, including operational SOPs, work instructions, system impact assessments, change controls, as needed.
  • Track and resolve LIMS support program issues and identify potential enhancements to the system.
  • Independently plan, manage, and execute assignments, contribute to project planning meetings.
  • Support product stability programs, including generating stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data.
  • All duties are performed with minimal supervision and oversight.
  • 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

  • Bachelor's degree in a relevant discipline (biological sciences, computer science, or equivalent).
  • Minimum of 5-10 years of experience in a cGMP laboratory, including at least 3 years as a LIMS administrator. Experience with configuring and implementing a LIMS.
  • Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.
  • Ability to manage external partners with respect to technical support activities.
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
  • Problem solver who not only identifies issues but leads efforts to resolve them.

Preferred Qualifications

  • Experience with cell and/or gene therapy products is a plus.
  • Experience with MS SQL Server or Oracle database is a plus.

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.
  • Must meet requirements for and be able to wear a half-face respirator.
  • Able to stand and/or walk 90% (and sit 10%) of a 10-hr day, which may include climbing ladders or steps.
  • Must be able to use near vision to view samples at close range.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 45 pounds.

Mental Demands

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

Equal Employment Opportunity

Iovance Biotherapeutics Inc is an equal-opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment and do not discriminate based on race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other characteristic protected by applicable law.

Accommodation

If you require accommodation to apply for this position, please contact Human Resources.

By submitting your application, you consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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