Senior Quality Control Analyst - Raw Material [3rd Floor Lab]

Iovance Biotherapeutics • Philadelphia, PA

309d

About The Position

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Senior Analyst, Quality Control (QC) Raw Materials, who will be responsible for the sampling, release testing, data review, and vendor qualification, for all raw material lots received for use in the manufacturing of product at the Iovance iCTC site. These activities include chemical and biological raw materials, component inspection, and final packaging.

Requirements

• Bachelor's degree in a relevant discipline (biological sciences or equivalent).
• Minimum five (5) years in a GxP regulated setting (pharmaceutical or biotechnology industry).
• Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
• Strong microbiological, analytical and technical background in compendial testing and related equipment.
• Experience in raw material inspection and testing practices.
• Experience leading and facilitating quality events including OOS investigations.
• Strong analytical and technical background in compendial testing and related equipment, including microbiology, potency, gel electrophoresis, wet chemistry, FT-IR, UV/VIS, KF, Titration, and GC methodologies.
• Experience with inspections/audits by FDA and other regulatory agencies.
• Experience in method validation and assay transfer.
• Experience with lab and data management systems (LIMS, Empower, Phenix).
• Experience managing a team a plus.
• Broad knowledge of biological drug development with respect to Quality Control.
• Demonstrated ability to manage external partners with respect to quality control activities.
• 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.
• 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.

Nice To Haves

• Experience with cell and/or gene therapy products is a plus.
• Experience with change controls, risk assessments, and validations is highly desirable.

Responsibilities

• Support the planning and establishment of the initial setup of internal raw material testing laboratory.
• Perform day-to-day activities for raw material release testing, including but not limited to USP<71> Sterility, USP <61> Growth Promotion, USP <63> / EP 2.6.7 Mycoplasma, USP<85> Bacterial Endotoxins, USP<197> Spectrophotometric Identification, USP <791> pH, USP <785> Osmolality, USP <841> Specific Gravity / Density, Identification by USP<191>, USP <788> / USP <787> Particulate Matter, Identification by ELISA/Immunoassay, Polyacrylamide Gel Electrophoresis, USP<643> Total Organic Carbon, and USP<645>Conductivity.
• Support Acceptable Quality Level (AQL) sampling and inspection, Carbon Dioxide (CO2) sampling and testing, and other raw material releases.
• Support all quality events and tasks associated to raw material release.
• Author, review, and/or execute SOPs, protocols, reports, specifications, and other quality control documents as applicable.
• Support raw materials vendor qualification program.
• Support efforts in on-going readiness for regulatory inspections and compliance audits.
• Participate in investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Support problem solving for technical issues, pertaining to raw material testing and release.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
• Provide supervision and oversight to entry-level analysts.
• Other duties, as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree