Qureos Mentor

Iovance Biotherapeutics

<div>Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Rotation Schedule:

Week 1: Shift A: Sunday to Tuesday from 5:00pm to 5:30am

Week 2 Shift A: Sunday to Wednesday from 5:00pm to 4:30am

Overview

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).

The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.

As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use.

This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.

Essential Functions and Responsibilities:
<ul>
<li>Develop a comprehensive understanding of and be able to proficiently execute Iovance's GMP cell therapy manufacturing process(es).</li>
<li>Complete training sessions and ensure training documentation is maintained.</li>
<li>Understand and comply with quality standards and requirements as documented.</li>
<li>Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).</li>
<li>Preps:
<ul><li>Provide operational support functions including:
<ul><li>Materials stocking and transfer.</li>
<li>Kit preparation.</li>
<li>Room readiness.</li>
<li>Equipment cleaning activities.</li>
<li>And inventory transactions using electronic inventory systems.</li>
</ul></li><li>Hallway:
<ul><li>Material transfer.</li>
<li>Tumor receipt.</li>
<li>Chain of Information/Chain of Custody transactions.</li>
<li>Material incubation.</li>
<li>Feeder cell retrieval from liquid nitrogen (LN2) tanks.</li>
<li>Able to perform final product visual inspection.</li>
<li>Final product cryopreservation in controlled rate freezers.</li>
</ul></li><li>BSCR:
<ul><li>Perform biosafety cabinet (BSC) runner duties as assigned.</li>
<li>Balance weight checks and operation.</li>
<li>Operation of liquid repeater pump.</li>
<li>Operation of tube sealers and welders.</li>
<li>Incubator-use for cell culture.</li>
</ul></li><li>EM:
<ul><li>Perform in-suite environmental monitoring during the day of process</li>
<li>Perform document Environmental Monitoring duties using sample management electronic system.</li>
</ul></li><li>Miscellaneous:
<ul><li>Able to train, pass and maintain gowning qualification.</li>
<li>Perform logbook review.</li>
<li>Attend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.</li>
<li>Ability to work in a team environment and independently as required.</li>
<li>Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.</li>
<li>Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.</li>
<li>Adherence to production schedule while maintaining internal production priorities.</li>
<li>Perform other duties as assigned.</li>
</ul>
</li></ul></li></ul>Required Education, Skills, and Knowledge
<ul>
<li>Bachelor's degree or equivalent experience.</li>
<li>Minimum 0-1 year of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.</li>
<li>Must be able to read, write and understand English especially for Good Documentation Practices.</li>
<li>Proficiency in Microsoft (Excel, Word, Outlook and Teams).</li>
<li>Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.</li>
<li>May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.</li>
<li>Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.</li>
<li>Ability to build relationships quickly and credibly.</li>
<li>Ability to work successfully in a fast-paced team-oriented environment and manage constant change.</li>
</ul>
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
<ul>
<li>Must not be color blind.</li>
<li>Must have 20/20 near vision in both eyes (can be corrected)</li>
<li>Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.</li>
</ul>
Physical Demands and Activities Required:
<ul>
<li>You must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.</li>
<li>Must meet requirements for and be able to wear a half-faced respirator for use of hazardous chemicals.</li>
<li>Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.</li>
<li>Able to crouch, bend, twist, reach, and perform activities with repetitive motions.</li>
<li>Must be able to lift and carry objects weighing 50 pounds.</li>
</ul>
Mental:
<ul>
<li>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 deadlines.</li>
</ul>
Work Environment:
<ul>
<li>This position will work in both an office and a manufacturing setting.</li>
<li>When in the cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.</li>
<li>Potential exposure to noise and equipment hazards and strong odors.</li>
</ul>
#LI-onsite<div>

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 &quot;Submit Application&quot;, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.</div></div>

Aseptic Manufacturing Technician I - Night Shift A [Contract to Hire]

<div>Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Rotation Schedule:

Week 1: Shift B: Thursday to Saturday from 18:00 to 06:30

Week 2 Shift B: Wednesday to Saturday from 18:00 to 05:30

Overview

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).

The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.

As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use.

This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.

Essential Functions and Responsibilities:
<ul>
<li>Develop a comprehensive understanding of and be able to proficiently execute Iovance's GMP cell therapy manufacturing process(es).</li>
<li>Complete training sessions and ensure training documentation is maintained.</li>
<li>Understand and comply with quality standards and requirements as documented.</li>
<li>Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).</li>
<li>Preps:
<ul><li>Provide operational support functions including:
<ul><li>Materials stocking and transfer.</li>
<li>Kit preparation.</li>
<li>Room readiness.</li>
<li>Equipment cleaning activities.</li>
<li>And inventory transactions using electronic inventory systems.</li>
</ul></li><li>Hallway:
<ul><li>Material transfer.</li>
<li>Tumor receipt.</li>
<li>Chain of Information/Chain of Custody transactions.</li>
<li>Material incubation.</li>
<li>Feeder cell retrieval from liquid nitrogen (LN2) tanks.</li>
<li>Able to perform final product visual inspection.</li>
<li>Final product cryopreservation in controlled rate freezers.</li>
</ul></li><li>BSCR:
<ul><li>Perform biosafety cabinet (BSC) runner duties as assigned.</li>
<li>Balance weight checks and operation.</li>
<li>Operation of liquid repeater pump.</li>
<li>Operation of tube sealers and welders.</li>
<li>Incubator-use for cell culture.</li>
</ul></li><li>EM:
<ul><li>Perform in-suite environmental monitoring during the day of process</li>
<li>Perform document Environmental Monitoring duties using sample management electronic system.</li>
</ul></li><li>Miscellaneous:
<ul><li>Able to train, pass and maintain gowning qualification.</li>
<li>Perform logbook review.</li>
<li>Attend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.</li>
<li>Ability to work in a team environment and independently as required.</li>
<li>Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.</li>
<li>Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.</li>
<li>Adherence to production schedule while maintaining internal production priorities.</li>
<li>Perform other duties as assigned.</li>
</ul>
</li></ul></li></ul>Required Education, Skills, and Knowledge
<ul>
<li>Bachelor's degree or equivalent experience.</li>
<li>Minimum 0-1 year of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.</li>
<li>Must be able to read, write and understand English especially for Good Documentation Practices.</li>
<li>Proficiency in Microsoft (Excel, Word, Outlook and Teams).</li>
<li>Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.</li>
<li>May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.</li>
<li>Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.</li>
<li>Ability to build relationships quickly and credibly.</li>
<li>Ability to work successfully in a fast-paced team-oriented environment and manage constant change.</li>
</ul>
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
<ul>
<li>Must not be color blind.</li>
<li>Must have 20/20 near vision in both eyes (can be corrected)</li>
<li>Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.</li>
</ul>
Physical Demands and Activities Required:
<ul>
<li>You must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.</li>
<li>Must meet requirements for and be able to wear a half-faced respirator for use of hazardous chemicals.</li>
<li>Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.</li>
<li>Able to crouch, bend, twist, reach, and perform activities with repetitive motions.</li>
<li>Must be able to lift and carry objects weighing 50 pounds.</li>
</ul>
Mental:
<ul>
<li>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 deadlines.</li>
</ul>
Work Environment:
<ul>
<li>This position will work in both an office and a manufacturing setting.</li>
<li>When in the cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.</li>
<li>Potential exposure to noise and equipment hazards and strong odors.</li>
</ul>
#LI-onsite<div>

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 &quot;Submit Application&quot;, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.</div></div>

Aseptic Manufacturing Technician I - Night Shift B [Contract to Hire]

<div>Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Must be onsite once or twice a week.

Overview

Iovance is seeking an experienced and highly motivated contract Recruiting Coordinator to join our HR team. The Recruiting Coordinator aids with and facilitate the movement of candidates through the recruitment process. This role is a key part of the recruiting team in coordinating and scheduling interviews, liaising with candidates/staffing agencies, and supporting the hiring process.

Specific Responsibilities
<ul>
<li>Support and assist recruiters in coordinating with candidates/ managers/ staffing agency to schedule interviews (phone/onsite/Zoom) across multiple department/offices.</li>
<li>Work with multiple scheduling changes and calendar changes with candidates and hiring managers.</li>
<li>Update the Req Report with recruiting activity and information required.</li>
<li>Post open positions on LinkedIn and other job posting boards.</li>
<li>Attending weekly TA meetings with the team and recruiting meeting and able to speak to updates and activities.</li>
<li>Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.</li>
<li>Perform miscellaneous duties as assigned.</li>
</ul>
Education and Qualifications
<ul>
<li>Bachelor's degree in human resources or related area.</li>
<li>1&ndash;3 years of experience in recruiting, talent acquisition, or HR coordination (or equivalent relevant experience).</li>
<li>Must have experience with Greenhouse ATS system or other ATS systems.</li>
<li>Effective HR administration and people management skills.</li>
<li>Excellent written and verbal communication skills.</li>
<li>Works well under pressure, meets tight deadlines with a sense of urgency.</li>
<li>Highly computer literate with capability in email, MS Office and Smartsheets.</li>
<li>Most have good organizational and time management skills.</li>
<li>Meticulous attention to detail.</li>
</ul>
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
<ul>
<li>Must be able to remain in a stationary position standing or sitting for prolonged periods of time.</li>
<li>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.</li>
<li>Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.</li>
<li>This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.</li>
<li>Must be able to communicate with others to exchange information.</li>
</ul>
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 deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.

#LI-Hybrid<div>

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 &quot;Submit Application&quot;, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.</div></div>

Recruiting Coordinator [Contract]

Join Iovance Biotherapeutics and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Iovance Biotherapeutics

About Company

Aseptic Manufacturing Technician I - Night Shift A [Contract to Hire]

Aseptic Manufacturing Technician I - Night Shift B [Contract to Hire]

Recruiting Coordinator [Contract]