Iovance Biotherapeutics, Inc.
Associate Director, Quality Assurance, Release
Iovance Biotherapeutics, Inc., Phila, Pennsylvania, United States, 19117
Overview
Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on tumor infiltrating lymphocytes (TIL). The Associate Director, Quality Assurance, 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
Lead team of Quality professionals to support routine release of raw materials, critical reagents, and TIL Drug Product materials in support of clinical and commercial operations.Responsible for QA release of internal manufacturing, raw materials, and components.Ensure appropriate and timely escalation of significant quality issuesManage batch record review.Approval of documentation from 3rd party warehouse as needed.Manage lot closure.Manage lot release and disposition activitiesManage Raw material release, Component release, and kit release as required to support manufacturingLead or provide strong support for investigation of deviations, nonconforming events, and corrective action/preventative action investigationsDrive 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 patientsSupport Change controls and other Quality System recordsDevelop and establish SOPs as needed for product releaseApprove label specificationsReview quality records and documentation for approval including master records, proceduresDevelop and maintain training matrix for release teamManage final product label issuance.Identify, propose, and help implement procedural changes aimed at improving product qualityEnsure knowledge sharing and collaborative troubleshootingProvide support for Iovance audits as requiredTrack and report on Quality Release metrics as requiredOther duties as assignedRequired Education, Skills, and Knowledge
B.S. degree in science. Advanced degree a plus.At least 10 years of experience in the pharmaceutical/biotech industry, with at least 6 years in a commercial manufacturing environment working in cell therapy or biologics release of drug product and materials. a minimum of 5 years supervisory experience required.Excellent interpersonal, verbal and written communication skills are essential in this collaborative position.Experience with label issuance for final drug productExperienced in troubleshooting, investigations, problem solving and in negotiating the path forward with multiple functions to ensure timely product release.Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.Ability to simultaneously manage multiple projectsAbility to follow through on all activities to ensure projects are completed as planned.Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.Able to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.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 deadlineWork 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 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.
#LI-onsite
Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on tumor infiltrating lymphocytes (TIL). The Associate Director, Quality Assurance, 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
Lead team of Quality professionals to support routine release of raw materials, critical reagents, and TIL Drug Product materials in support of clinical and commercial operations.Responsible for QA release of internal manufacturing, raw materials, and components.Ensure appropriate and timely escalation of significant quality issuesManage batch record review.Approval of documentation from 3rd party warehouse as needed.Manage lot closure.Manage lot release and disposition activitiesManage Raw material release, Component release, and kit release as required to support manufacturingLead or provide strong support for investigation of deviations, nonconforming events, and corrective action/preventative action investigationsDrive 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 patientsSupport Change controls and other Quality System recordsDevelop and establish SOPs as needed for product releaseApprove label specificationsReview quality records and documentation for approval including master records, proceduresDevelop and maintain training matrix for release teamManage final product label issuance.Identify, propose, and help implement procedural changes aimed at improving product qualityEnsure knowledge sharing and collaborative troubleshootingProvide support for Iovance audits as requiredTrack and report on Quality Release metrics as requiredOther duties as assignedRequired Education, Skills, and Knowledge
B.S. degree in science. Advanced degree a plus.At least 10 years of experience in the pharmaceutical/biotech industry, with at least 6 years in a commercial manufacturing environment working in cell therapy or biologics release of drug product and materials. a minimum of 5 years supervisory experience required.Excellent interpersonal, verbal and written communication skills are essential in this collaborative position.Experience with label issuance for final drug productExperienced in troubleshooting, investigations, problem solving and in negotiating the path forward with multiple functions to ensure timely product release.Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.Ability to simultaneously manage multiple projectsAbility to follow through on all activities to ensure projects are completed as planned.Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.Able to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.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 deadlineWork 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 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.
#LI-onsite