Manager, Quality Control, Raw Material [3rd Floor Lab]

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  Iovance is seeking a Manager, Quality Control (QC) Raw Materials, who will be responsible for oversight and management of the QC Raw Material Program at the iCTC site. The manager will be expected to manage and oversee the responsibilities relating to 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.

A good understanding of QC test methods and raw materials release requirements, per USP and EP compendia, is desired.  Experience working in a GMP-regulated environment is essential. The position will report to the Senior Manager, Quality Control – Raw Materials.

Essential Functions and Responsibilities

• Plan and establish the initial setup of internal raw material testing laboratory.
• Hire, train, and manage direct report in the Quality Control Raw Materials testing laboratory.
• Lead and provide scientific oversight of bioassays, safety assays, and bioanalytical studies including qualification, validation, verification and comparability of assays utilizing a variety of microbiological and analytical techniques and instrumentation.
• Subject matter expertise in developing and performing microbiological and analytical methods and data analysis of results for various analytical methodologies 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.
• Expertise in generating microbiological and analytical methods validation master plans is highly beneficial.
• Lead study design for microbiological and analytical runs and investigations, data analysis, as well as culmination and presentation of data for peer review and in support of Regulatory agency submissions.
• Provide project management oversight of and demonstrate ability to troubleshoot external contracts for microbiological and analytical method development and validation, for raw material and excipient release testing.
• Schedule and manage the day-to-day raw material release operations for release testing.
• Oversight and management of QC raw material schedule in alignment with the iCTC site demand.
• Oversight and maintenance of the training program to ensure adequate training within QC Raw Material Group.
•   Technical reviewer of raw material releases.Support Acceptable Quality Level (AQL) sampling and inspection, Carbon Dioxide (CO2) sampling and testing, and other raw material releases, including technical review.
• Manage on-time closure of all quality events and tasks associated to raw material release.
• Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents as applicable.
• Manage raw materials vendor qualification program.

• Act as subject matter expert (SME) for specified functions within QC related to raw materials.
• Lead efforts in on-going readiness for regulatory inspections and compliance audits.
• Provide leadership to the QC Raw Material Group that includes promoting development, timely communication and fostering an open and positive teamwork environment.
• Promote and act as the continuous improvement champion within the QC Raw Material Group
• Act as liaison between QC Raw Material Group /other departments to communicate release schedules.
• Plan, manage and execute assignments, contribute to project planning meetings.
• Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notification.
• Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars.
• Lead 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.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• All duties are performed with minimal supervision and oversight.
• Provide supervision and oversight to analysts and/or supervisors.
• Other Duties, as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree or higher in a relevant discipline (biological sciences or equivalent).
• Minimum (8) years in a GxP regulated setting (pharmaceutical or biotechnology industry); experience with cell and/or gene therapy products is a plus.

• Experience managing a team a plus.
• 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).
• 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.

Preferred Education, Skills, and Knowledge

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

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate Personal Protective Equipment (PPE), i.e. safety glasses, shoes, vest.
• 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 25 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 deadline

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 Lab 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.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s 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, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

By voluntarily providing information and clicking “Submit Application”, you explicitly 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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