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). TLead Aseptic Manufacturing Technician - Night Shift A Sun - Wed-5pm - 5:30am 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:
•Develop a comprehensive understanding of and be able to proficiently execute Iovance’s GMP cell therapy manufacturing process(es).
•Complete training sessions and ensure training documentation is maintained.
•Understand and comply with quality standards and requirements as documented.
•Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
•Preps:
oProvide operational support functions including:
▪Materials stocking and transfer.
▪Kit preparation.
▪Room readiness.
▪Equipment cleaning activities.
▪And inventory transactions using electronic inventory systems.
•Hallway:
oMaterial transfer.
oTumor receipt.
oChain of Information/Chain of Custody transactions.
oMaterial incubation.
oFeeder cell retrieval from liquid nitrogen (LN2) tanks.
oAble to perform final product visual inspection.
oFinal product cryopreservation in controlled rate freezers.
•BSCR:
oPerform biosafety cabinet (BSC) runner duties as assigned.
oBalance weight checks and operation.
oOperation of liquid repeater pump.
oOperation of tube sealers and welders.
oIncubator-use for cell culture.
•EM:
oPerform in-suite environmental monitoring during the day of process
oPerform document Environmental Monitoring duties using sample management electronic system.
•Miscellaneous:
oAble to train, pass and maintain gowning qualification.
oPerform logbook review.
oAttend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.
oAbility to work in a team environment and independently as required.
oMust adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
oMust comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
oAdherence to production schedule while maintaining internal production priorities.
oPerform other duties as assigned.

Required Education, Skills, and Knowledge
•Bachelor’s degree or equivalent experience.
•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.
•Must be able to read, write and understand English especially for Good Documentation Practices.
•Proficiency in Microsoft (Excel, Word, Outlook and Teams).
•Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
•May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
•Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
•Ability to build relationships quickly and credibly.
•Ability to work successfully in a fast-paced team-oriented environment and manage constant change.

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:
• Must not be color blind.
• Must have 20/20 near vision in both eyes (can be corrected)
• 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. Physical Demands and Activities Required:
•You must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
•Must meet requirements for and be able to wear a half-faced respirator for use of hazardous chemicals.
•Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
•Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
•Must be able to lift and carry objects weighing 50 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 deadlines.Work Environment:
•This position will work in both an office and a manufacturing setting.
•When in the cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.
•Potential exposure to noise and equipment hazards and strong odors.

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Rotation Schedule:

Week 1: Shift B: Thursday to Saturday from 0700 to 1930

Week 2 Shift B: Wednesday to Saturday from 0700 to 1830

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 (1^st 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:

• Develop a comprehensive understanding of and be able to proficiently execute Iovance’s GMP cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Preps:
  • Provide operational support functions including:
    • Materials stocking and transfer.
    • Kit preparation.
    • Room readiness.
    • Equipment cleaning activities.
    • And inventory transactions using electronic inventory systems.
  • Hallway:
    • Material transfer.
    • Tumor receipt.
    • Chain of Information/Chain of Custody transactions.
    • Material incubation.
    • Feeder cell retrieval from liquid nitrogen (LN2) tanks.
    • Able to perform final product visual inspection.
    • Final product cryopreservation in controlled rate freezers.
  • BSCR:
    • Perform biosafety cabinet (BSC) runner duties as assigned.
    • Balance weight checks and operation.
    • Operation of liquid repeater pump.
    • Operation of tube sealers and welders.
    • Incubator-use for cell culture.
  • EM:
    • Perform in-suite environmental monitoring during the day of process
    • Perform document Environmental Monitoring duties using sample management electronic system.
  • Miscellaneous:
    • Able to train, pass and maintain gowning qualification.
    • Perform logbook review.
    • Attend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.
    • Ability to work in a team environment and independently as required.
    • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
    • Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
    • Adherence to production schedule while maintaining internal production priorities.
    • Perform other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree or equivalent experience.
• 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.
• Must be able to read, write and understand English especially for Good Documentation Practices.
• Proficiency in Microsoft (Excel, Word, Outlook and Teams).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced team-oriented environment and manage constant change.

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: 

• Must not be color blind.
• Must have 20/20 near vision in both eyes (can be corrected)
• 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.

Physical Demands and Activities Required:

• You must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-faced respirator for use of hazardous chemicals.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 50 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 deadlines. 

Work Environment: 

• This position will work in both an office and a manufacturing setting.
• When in the cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.
• Potential exposure to noise and equipment hazards and strong odors. 

#LI-onsite

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.

Schedule & Hours: 

Monday to Friday from 15:00-23:30

Overview

Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on TIL. The company’s lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has a commercially approved product along with multiple ongoing clinical trials in various phases for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company is currently developing its commercial manufacturing capacity to support development and launch of these assets.

Essential Functions and Responsibilities

• Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
• Own and manage change controls associated with manufacturing areas and equipment.
• Participate in technology transfer, conference calls and sharing of technical information.
• Coordination of front-end document requests with supporting departments.
• Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attends the weekly management meeting to discuss timelines and weekly priorities.
• Contribute to projects to ensure timely initiation and completion of work.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
•Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.

•Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
•Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
• 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.

Travel

May require up to 10% travel, based on business need.

Required Education, Skills, and Knowledge

• Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
•Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
•Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
•Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
•Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
•Ability to work successfully in a fast-paced, team-oriented environment.
•Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
•Excellent presentation skills, both written and verbal.
•Understands and complies with quality standards and requirements as documented.
•Must have strong written and verbal communication and organizational skills.
•Strong computer skills, problem solving and attention to detail.
•Familiarity with data and sample management required (LIMS/MES).
•Able to work independently with minimal supervision.
•Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
•This position is currently for regular work week hours (1st shift M-F).
•Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

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 clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
•Able to stand and/or walk 90% (and sit 10%) which may include climbing ladders or steps.
•Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
•Must be able to lift and carry objects weighing 45 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 deadlines.

Work Environment

•This position will work in both an office and a manufacturing cleanroom setting.
•When in the lab, must be able to work in cleanroom 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.

#LI-onsite

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.

Overview

The Supervisor for Aseptic Manufacturing oversees the production process to ensure that all materials are produced safely and follow the company's standards. This position requires timely document review and ensuring all targets are met. In addition, the supervisor will be responsible for developing staff and implementing an effective "First-time right" program to meet Iovance's growing demands. The successful candidate will also help onboard new team members and manage deviations and CAPAs for the training and learning team. It is crucial that the supervisor has innovative technical knowledge and contributes significantly to the overall manufacturing operation. As a leadership team member for autologous cell therapy manufacturing operations, a background in cell culture and manufacturing in ISO class 5 cleanrooms is necessary.

Essential Functions and Responsibilities

• Supervision and Development direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff to foster a culture of continuous improvement and operational excellence.
• Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.
• Develop a comprehensive understanding of the current production process, as this role is viewed as a subject matter expert within a specific area. Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility are required.
• Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and utilize proper aseptic techniques.
• Review batch documentation and logbooks for completeness and accuracy.
• Ability to work under limited supervision and handle problems of a more complex nature.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of the operation.
• Establish objectives and conduct performance reviews, monitor progress toward goals, and provide timely feedback to Management.
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Ensure the department understands and complies with quality standards and requirements as documented.
• Ensure efficient operations and compliance with cGMPs and safety regulations. • Work in a cleanroom with biohazards, human blood components, and chemicals • 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.

Travel - 10%

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 manufacturing operations, including experience in cell culture and associated downstream processing. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Strong knowledge and experience of the end-to-end learning process, i.e., learning needs assessment, program design and delivery, and learning evaluation and training effectiveness assessment.
• Demonstrates strong oral and written communication skills and actively contributes to training, report generation, and documentation (batch records, deviations, etc.). Strong technical writing ability is required.
• Experience leading “development” initiatives, i.e., training, coaching, and learning initiatives.
• Ability to mentor and provide best practices to other team members.
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to the entire staff, with the ability to manage and influence large teams within the manufacturing environment (potentially 50+ employees) representing a variety of personalities and experience levels.
• Proactive, results-oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Ability to work successfully in a fast-paced, team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Remains current regarding Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to address compliance issues fully.

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.

For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
• Must not be color blind.
• Must have 20/20 near vision in both eyes (can be corrected)

Physical Demands and Activities Required

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

#LI-onsite