Quality Control Technician
Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The company's lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support development and launch of these assets.
Iovance Biotherapeutics is seeking a Quality Control Technician to join the team at 700 Spring Garden St, Philadelphia, PA. Co-located at the American Red Cross Penn Jersey Region, this Iovance facility produces a critical raw material used in the company's TIL process. The critical raw material is processed from leukapheresis units and frozen. Processing is performed in an ISO 7 cleanroom within an ISO 5 biological safety cabinet. The Quality Control Technician's primary responsibility is to conduct release testing on each critical raw material lot produced by the manufacturing team. The release tests include automated cell counting and tissue culture based assays.
A background in tissue culture is preferred, but not required.
Complete training sessions and ensure training documentation is maintained.
Proficiently carry out procedures to achieve a consistent, error-free execution of daily job assignments
Test each lot according to standard operating procedures (SOPs), accurately and fully complete forms to document testing.
At all times, understand and comply with quality standards and safety guidelines
Perform materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
Identify errors and report them promptly to lab management. Participate in root cause analysis and implement corrective actions.
Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
Other duties as assigned.
Minimum A.S. degree in biology, chemistry, or related technical field, or equivalent industry experience.
Minimum of 0-2 years of experience in biopharmaceutical based GMP manufacturing operations or quality control. Tissue culture experience preferred.
Able to accurately perform basic math, including fractions, decimals, and percentages.
Able to work effectively with team members and show initiative to assist others on the team when needed
Able 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.
Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
Quality Control Technicians are required to work their assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of processing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.
Able to read, write and understand English, and be proficient in Microsoft Office (Excel, Word, Outlook).
Able to work in laboratory with biohazards, human blood components, chemicals, and variable noise levels.
Able to don personal protective equipment.
Able to see at near and mid-range with depth perception.
Able to stand/sit/walk for long periods of time.
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Able to lift 20 lbs.
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Iovance Biotherapeutics Inc.