Location: Philadelphia,PA, USA
Overview
Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on tumor infiltrating lymphocytes (TIL). The Supervisor, Quality Assurance, Raw Material Release is a newly created position that requires a highly independent individual with strong communication skills.
The position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between manufacturing and Iovance Quality, with the goal of optimizing informed decision making. The position will be fluent in release processes and procedures.
Monday to Friday-standard hours.
Essential Functions and Responsibilities
* Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence.
* Perform real-time support for escalations to ensure compliance with GMP and GDP quality initiatives.
* Ensure appropriate and timely escalation of significant quality issues
* Schedule and coordinate daily activities for raw material release ensuring conformance to the daily schedule and overall site compliance.
* Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.
* Support lot release and disposition activities, as required
* Support final product drug label issuance and reconciliation
* Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
* Drive continuous improvements to systems, policies, procedures, and ways of working to create a more efficient release process that is agile, nimble, compliant, and meets the needs of the business to serve autologous cell therapy patients.
* Review of Quality System records for compliance.
* Must adhere to Iovance Biotherapeutics' 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.
* Provide support for Iovance audits as required
* Track data for Quality Release metrics as required
* Other duties as assigned
Required Education, Skills, and Knowledge
* Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience.
* Minimum of 5 years of experience in biopharmaceutical-based GMP cell therapy or bioloigcs industry. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.
* Quality release experience is required.
* Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals; 21 CFR 1271 is a plus
* Excellent oral and written communication skills
* Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner
* Must be comfortable in a fast-paced environment and changing priorities
* Experience with use of an electronic QMS, MasterControl
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 remain in a stationary position standing or sitting for prolonged periods of time.
* Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
* Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
* This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
* Must be able to communicate with others to exchange information.
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 setting.
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 ...@iovance.com.
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